Major Depression
Conditions
Keywords
Depression
Brief summary
This is a two-part (open-label followed by double-blind) study evaluating the safety, tolerability, pharmacokinetics, and efficacy of SAGE-217 in 102 participants diagnosed with moderate to severe Major Depressive Disorder.
Detailed description
Part A of the study is an open-label design with dosing of SAGE-217 for 14 days. Part B of the study is a randomized, double-blind, parallel-group, placebo-controlled design. Eligible participants were randomized to SAGE-217 or placebo for 14 days. This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.
Interventions
DRUGSAGE-217
DRUGPlacebo
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Participant has a diagnosis of Major Depressive Disorder that has been present for at least a 4-week period as diagnosed by Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I)
Exclusion criteria
* Participant has a history of suicide attempt * Participant has a history of treatment-resistant depression, defined as persistent depressive symptoms despite treatment with adequate doses of antidepressants from two different classes for an adequate amount of time * Participant has active psychosis * Participant has a medical history of seizures * Participant has a medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part A | Day 1 up to Day 21 | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was defined as an adverse event with onset after the start of study drug, or any worsening of a pre-existing medical condition/adverse event with onset after the start of study drug and until 7 days after the last dose. The analysis was performed in participants included in Part A of the study. |
| Percentage of Participants With TEAEs, Graded by Severity - Part A | Day 1 up to Day 21 | Severity was assessed according to the following scale: mild (awareness of sign or symptom, but easily tolerated); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with inability to perform normal activities). The analysis was performed in participants included in Part A of the study. |
| Change From Baseline in Basophils - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Basophils to Leukocytes Ratio [Percentage (%)] - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as International System (SI) unit, percentage (%). |
| Change From Baseline in Eosinophils - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| Change From Baseline in Hematocrit - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Hemoglobin - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Lymphocytes - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| Change From Baseline in Monocytes - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| Change From Baseline in Neutrophils - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| Change From Baseline in Platelets - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Erythrocytes - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Reticulocytes - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Leukocytes - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Albumin - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Alkaline Phosphatase - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Alanine Aminotransferase - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Aspartate Aminotransferase - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Bilirubin - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Chloride - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Carbon Dioxide - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Creatinine - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Potassium - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Protein - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Sodium - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Urea Nitrogen - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Activated Partial Thromboplastin Time - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Prothrombin International Normalized Ratio (%) - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The data for prothrombin international normalized ratio are presented as SI unit, percentage (%). |
| Change From Baseline in Prothrombin Time - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in pH - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Urinalysis measures included pH and specific gravity. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline in Specific Gravity - Part A | Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28 | Urinalysis measures included pH and specific gravity. The analysis was performed in participants included in Part A of the study. ET = Early Termination. |
| Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. |
| Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. |
| Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. |
| Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. |
| Change From Baseline (CFB) in Heart Rate - Part A | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. |
| Change From Baseline (CFB) in Respiratory Rate - Part A | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. |
| Change From Baseline (CFB) in Oral Temperature - Part A | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28 | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination. |
| Change From Baseline (CFB) in Oxygen Saturation - Part A | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Day 8 (predose, 1 hour postdose) | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). |
| Change From Baseline in QT Interval - Part A | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 | Electrocardiogram (ECG) measures included QT interval, QTc based on Fridericia formula (QTcF interval), ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. |
| Change From Baseline in QTcF Interval - Part A | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. |
| Change From Baseline in ECG Mean Heart Rate - Part A | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. |
| Change From Baseline in RR Interval - Part A | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. |
| Change From Baseline in PR Interval - Part A | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. |
| Change From Baseline in QRS Interval - Part A | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study. |
| Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Item - Part A | Day 1 up to Day 28 | The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation (SI) and behavior and a postbaseline evaluation that focused on suicidality since the last study visit. The C-SSRS included yes or no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with specific plan. The analysis was performed in participants included in Part A of the study. |
| Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 15 - Part A | Baseline, Day 15 | The SSS was participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of one to seven, where the lowest score of 'one' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of 'seven' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. A negative change from baseline indicated less sleepiness. A positive change from baseline indicated more sleepiness. The analysis was performed in participants included in Part A of the study. |
| Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 - Part B | Baseline, Day 15 | The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in QTcF Interval - Part B | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. |
| Change From Baseline in ECG Mean Heart Rate - Part B | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. |
| Change From Baseline in RR Interval - Part B | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. |
| Change From Baseline in PR Interval - Part B | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. |
| Change From Baseline in QRS Duration - Part B | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. |
| Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Screening, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 15, 21, 28, 35 and 42 | The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation and behavior and a postbaseline evaluation that focused on suicidality since the last study visit. The C-SSRS included yes or no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with specific plan. The analysis was performed in participants included in Part B of the study. SCLR = screening: lifetime recall. |
| Percentage of Participants With HAM-D Response - Part A | Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 | HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score. The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicate a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of the study. Data is reported for participants who had HAM-D response. |
| Percentage of Participants With HAM-D Remission - Part A | Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 | HAM-D remission was defined as having a HAM-D total score of ≤7. The HAM-D total score comprised a sum of the 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of the study. |
| Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part A | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 | The MADRS was a ten-item diagnostic questionnaire which psychiatrists used to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicated more severe depression. A negative change from baseline indicated less severe depression. A positive change from baseline indicated more severe depression. The analysis was performed in participants included in Part A of the study. |
| Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 | HAM-D subscales were: Core, symptoms: depressed mood (DM), feelings of guilt (FG), suicide, work and activities (WA), and retardation (RE); Anxiety, symptoms: anxiety (psychic and somatic), somatic symptoms (SS) (gastrointestinal and general), hypochondriasis, and loss of weight; Bech-6, symptoms: DM, FG, WA, RE, anxiety psychic (AP), and SS general; and Maier, symptoms: DM, FG, WA, RE, agitation, and AP. Each item was scored in a range of 0 to 2 or 0 to 4. Higher scores indicated a greater degree of depression. Subscale scores were calculated as sum of individual rating scores related to each subscale, divided by total possible score within subscale, multiplied by 100, and rounded to a whole number. Therefore, subscale scores would be within range of 0-100 and might be larger than total score. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of study. |
| Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 | The HAM-D comprised individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms \[gastrointestinal (GI) and general\], genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of the study. |
| Change From Baseline in the HAM-D Total Score at Day 15 and All Other Time Points - Part A | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28 | The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicate a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of the study. |
| Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response - Part A | Days 2, 3, 8, 15, 21 and 28 | The CGI-I item employed a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions. CGI-I response was defined as having a CGI-I global improvement score of 1 (very much improved) or 2 (much improved). The analysis was performed in participants included in Part A of the study. Data is reported for participants who had CGI-I response. |
| Change From Baseline (CFB) in the SSS Score - Part B | Baseline, Day 1 (0.25, 0.5, 1, 2 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15 | The SSS was participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of one to seven, where the lowest score of 'one' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of 'seven' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. A negative change from baseline indicated less sleepiness. A positive change from baseline indicated more sleepiness. The analysis was performed in participants included in Part B of the study. H = Hour(s). |
| Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21, 28, 35 and 42 | The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study. |
| Percentage of Participants With HAM-D Response - Part B | Days 2, 8, 15, 21, 28, 35 and 42 | HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score. The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study. Data is reported for participants who had HAM-D response. |
| Percentage of Participants With HAM-D Remission - Part B | Days 2, 8, 15, 21, 28, 35 and 42 | HAM-D remission was defined as having a HAM-D total score of ≤7. The HAM-D total score comprised a sum of the 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study. |
| Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B | Baseline, Days 2, 8, 15, 21, 28, 35 and 42 | The MADRS was a ten-item diagnostic questionnaire which psychiatrists used to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicated more severe depression. A negative change from baseline indicated less severe depression. A positive change from baseline indicated more severe depression. The analysis was performed in participants included in Part B of the study. |
| Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21, 28, 35 and 42 | HAM-D subscales were: Core, symptoms: depressed mood (DM), feelings of guilt (FG), suicide, work and activities (WA), and retardation (RE); Anxiety, symptoms: anxiety (psychic and somatic), somatic symptoms (SS) (gastrointestinal and general), hypochondriasis, and loss of weight; Bech-6, symptoms: DM, FG, WA, RE, anxiety psychic (AP), and SS general; and Maier, symptoms: DM, FG, WA, RE, agitation, and AP. Each item was scored in a range of 0 to 2 or 0 to 4. Higher scores indicated a greater degree of depression. Subscale scores were calculated as sum of individual rating scores related to each subscale, divided by total possible score within subscale, multiplied by 100, and rounded to a whole number. Therefore, subscale scores would be within range of 0-100 and might be larger than total score. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of study. |
| Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21, 28, 35 and 42 | The HAM-D comprised individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (GI and general), genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study. |
| Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B | Baseline, Days 2, 8, 15, 21, 28, 35 and 42 | The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms, and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scoring for HAM-A was calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56, where 0-13=Normal, 14-17 Mild Anxiety, 18-24 Moderate Anxiety, \>=25 Severe Anxiety, per the Psych Congress Network. The HAM-A total score was calculated as the sum of the 14 individual item scores. A negative change from baseline indicated less anxiety. A positive change from baseline indicated more anxiety. The analysis was performed in participants included in Part B of the study. |
| Percentage of Participants With CGI-I Response - Part B | Days 2, 8, 15, 21, 28, 35 and 42 | The CGI-I item employed a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions. CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved). The analysis was performed in participants included in Part B of the study. Data is reported for participants who had CGI-I response. |
| Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points - Part A | Baseline, Days 2, 3, 8, 15, 21 and 28 | The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms, and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scoring for HAM-A was calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56, where 0-13=Normal, 14-17 Mild Anxiety, 18-24 Moderate Anxiety, \>=25 Severe Anxiety, per the Psych Congress Network. The HAM-A total score was calculated as the sum of the 14 individual item scores. A negative change from baseline indicated less anxiety. A positive change from baseline indicated more anxiety. The analysis was performed in participants included in Part A of the study. |
| Percentage of Participants With TEAEs - Part B | Day 1 up to Day 21 | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an adverse event with onset after the start of study drug, or any worsening of a pre-existing medical condition/adverse event with onset after the start of study drug and until 7 days after the last dose. The analysis was performed in participants included in Part B of the study. |
| Percentage of Participants With AEs During Post-TEAE Period | Day 21 up to Day 42 | An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAE was defined as an adverse event with onset after the start of study drug, or any worsening of a pre-existing medical condition/adverse event with onset after the start of study drug and until 7 days after the last dose. Post-TEAE period was defined as 7 days after final dose through last follow-up (Day 42). The analysis was performed in participants included in Part B of the study. |
| Percentage of Participants With TEAEs, Graded by Severity - Part B | Day 1 up to Day 21 | Severity was assessed according to the following scale: mild (awareness of sign or symptom, but easily tolerated); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with inability to perform normal activities). The analysis was performed in participants included in Part B of the study. |
| Change From Baseline in Basophils - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| Change From Baseline in Eosinophils - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| Change From Baseline in Hematocrit - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Hemoglobin - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Lymphocytes - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| Change From Baseline in Monocytes - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| Change From Baseline in Neutrophils - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| Change From Baseline in Platelets - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Erythrocytes - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Reticulocytes - Part B | Baseline, Day 8, Day 15/ET | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%). |
| Change From Baseline in Leukocytes - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Albumin - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Alkaline Phosphatase - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Alanine Aminotransferase - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Aspartate Aminotransferase - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Bilirubin - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Calcium - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Chloride - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Carbon Dioxide - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Creatinine - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Glucose - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Potassium - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Magnesium - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Phosphate - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Protein - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Sodium - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Thyrotropin - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Urea Nitrogen - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Activated Partial Thromboplastin Time - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The data for prothrombin international normalized ratio are presented as SI unit, percentage (%). |
| Change From Baseline in Prothrombin Time - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in pH - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Urinalysis measures included pH and specific gravity. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline in Specific Gravity - Part B | Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42 | Urinalysis measures included pH and specific gravity. The analysis was performed in participants included in Part B of the study. ET = Early Termination. |
| Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. |
| Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. |
| Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. |
| Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. |
| Change From Baseline (CFB) in Heart Rate - Part B | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. |
| Change From Baseline (CFB) in Respiratory Rate - Part B | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. |
| Change From Baseline (CFB) in Oral Temperature - Part B | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42 | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. |
| Change From Baseline (CFB) in Oxygen Saturation - Part B | Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Day 8 (predose, 1 hour postdose) | Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination. |
| Change From Baseline in QT Interval - Part B | Baseline, Days 1, 2, 7, 14 and follow-up Day 21 | ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study. |
Countries
United States
Participant flow
Recruitment details
In Part A, 21 participants were screened; 13 received at least one dose of study drug. In Part B, 169 participants were screened; 89 received at least one dose of study drug.
Participants by arm
| Arm | Count |
|---|---|
| Part A: SAGE-217 Participants received SAGE-217, 30 mg, oral solution, once daily for 14 days, as tolerated. | 13 |
| Part B: Placebo Eligible participants received matching placebo capsules once daily for 14 days. | 44 |
| Part B: SAGE-217 Eligible participants received SAGE-217, 30 mg, oral capsules, once daily for 14 days. | 45 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 2 |
| Overall Study | Lost to Follow-up | 0 | 3 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Part B: Placebo | Total | Part B: SAGE-217 | Part A: SAGE-217 |
|---|---|---|---|---|
| 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score - Part B | 25.7 score on a scale STANDARD_DEVIATION 2.42 | 25.5 score on a scale STANDARD_DEVIATION 2.5 | 25.2 score on a scale STANDARD_DEVIATION 2.58 | — |
| Age, Continuous | 38.3 years STANDARD_DEVIATION 12.15 | 44.3 years STANDARD_DEVIATION 13.83 | 49.1 years STANDARD_DEVIATION 13.61 | 48.0 years STANDARD_DEVIATION 12.83 |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 28 Participants | 73 Participants | 36 Participants | 9 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 7 Participants | 9 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 37 Participants | 93 Participants | 44 Participants | 12 Participants |
| Race/Ethnicity, Customized Other | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 16 Participants | 27 Participants | 7 Participants | 4 Participants |
| Sex: Female, Male Female | 30 Participants | 64 Participants | 25 Participants | 9 Participants |
| Sex: Female, Male Male | 14 Participants | 38 Participants | 20 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 44 | 0 / 45 |
| other Total, other adverse events | 12 / 13 | 12 / 44 | 15 / 45 |
| serious Total, serious adverse events | 0 / 13 | 0 / 44 | 0 / 45 |
Outcome results
Primary
Change From Baseline (CFB) in Heart Rate - Part A
Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination.
Time frame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | Baseline | 80.0 beats per minute (beats/min) | Standard Deviation 13.1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 1: 0.25 H Postdose | -2.7 beats per minute (beats/min) | Standard Deviation 9.91 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 1: 0.5 H Postdose | -5.9 beats per minute (beats/min) | Standard Deviation 13.44 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 1: 1 H Postdose | -4.6 beats per minute (beats/min) | Standard Deviation 13.07 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 1: 2 H Postdose | -2.6 beats per minute (beats/min) | Standard Deviation 14.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 1: 12 H Postdose | -2.2 beats per minute (beats/min) | Standard Deviation 15.22 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 2: Predose | -6.6 beats per minute (beats/min) | Standard Deviation 14.66 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 2: 0.25 H Postdose | -6.6 beats per minute (beats/min) | Standard Deviation 13.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 2: 0.5 H Postdose | -6.4 beats per minute (beats/min) | Standard Deviation 12.96 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 2: 1 H Postdose | -2.8 beats per minute (beats/min) | Standard Deviation 16.75 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 2: 2 H Postdose | -3.5 beats per minute (beats/min) | Standard Deviation 13.97 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 2: 12 H Postdose | -10.7 beats per minute (beats/min) | Standard Deviation 14.68 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 3: Predose | -4.8 beats per minute (beats/min) | Standard Deviation 15.82 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 3: 0.25 H Postdose | -6.1 beats per minute (beats/min) | Standard Deviation 18.02 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 3: 0.5 H Postdose | -6.1 beats per minute (beats/min) | Standard Deviation 14.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 3: 1 H Postdose | -1.2 beats per minute (beats/min) | Standard Deviation 13.83 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 3: 2 H Postdose | -1.4 beats per minute (beats/min) | Standard Deviation 16.19 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 3: 12 H Postdose | -8.2 beats per minute (beats/min) | Standard Deviation 15.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 4: Predose | -6.8 beats per minute (beats/min) | Standard Deviation 15.33 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 4: 0.25 H Postdose | -8.5 beats per minute (beats/min) | Standard Deviation 15.58 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 4: 0.5 H Postdose | -5.3 beats per minute (beats/min) | Standard Deviation 14.09 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 4: 1 H Postdose | -5.0 beats per minute (beats/min) | Standard Deviation 15.46 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 4: 2 H Postdose | 0.7 beats per minute (beats/min) | Standard Deviation 12.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 4: 12 H Postdose | -5.2 beats per minute (beats/min) | Standard Deviation 12.39 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 5: Predose | -5.2 beats per minute (beats/min) | Standard Deviation 12.39 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 5: 0.25 H Postdose | -6.7 beats per minute (beats/min) | Standard Deviation 16.93 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 5: 0.5 H Postdose | -4.4 beats per minute (beats/min) | Standard Deviation 16.11 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 5: 1 H Postdose | -3.2 beats per minute (beats/min) | Standard Deviation 13.57 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 5: 2 H Postdose | -1.0 beats per minute (beats/min) | Standard Deviation 13.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 5: 12 H Postdose | -2.6 beats per minute (beats/min) | Standard Deviation 14.71 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 6: Predose | -2.2 beats per minute (beats/min) | Standard Deviation 13.98 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 6: 0.25 H Postdose | -4.8 beats per minute (beats/min) | Standard Deviation 13.49 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 6: 0.5 H Postdose | -4.8 beats per minute (beats/min) | Standard Deviation 14.9 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 6: 1 H Postdose | -0.5 beats per minute (beats/min) | Standard Deviation 15.98 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 6: 2 H Postdose | -3.5 beats per minute (beats/min) | Standard Deviation 13.48 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 6: 12 H Postdose | -5.8 beats per minute (beats/min) | Standard Deviation 20.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 7: Predose | -3.0 beats per minute (beats/min) | Standard Deviation 20.13 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 7: 0.25 H Postdose | -4.6 beats per minute (beats/min) | Standard Deviation 16.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 7: 0.5 H Postdose | -6.2 beats per minute (beats/min) | Standard Deviation 15.53 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 7: 1 H Postdose | -1.0 beats per minute (beats/min) | Standard Deviation 16.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 7: 2 H Postdose | -0.1 beats per minute (beats/min) | Standard Deviation 16.12 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 7: 12 H Postdose | -7.0 beats per minute (beats/min) | Standard Deviation 18.16 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 8: Predose | -2.1 beats per minute (beats/min) | Standard Deviation 15.74 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 8: 1 H Postdose | -1.0 beats per minute (beats/min) | Standard Deviation 16.07 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 9: Predose | -0.1 beats per minute (beats/min) | Standard Deviation 15.18 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 9: 1 H Postdose | 0.2 beats per minute (beats/min) | Standard Deviation 18.44 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 10: Predose | -1.8 beats per minute (beats/min) | Standard Deviation 15.39 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 10: 1 H Postdose | 0.7 beats per minute (beats/min) | Standard Deviation 13.91 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 11: Predose | 3.3 beats per minute (beats/min) | Standard Deviation 12.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 11: 1 H Postdose | -5.2 beats per minute (beats/min) | Standard Deviation 13.56 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 12: Predose | 1.9 beats per minute (beats/min) | Standard Deviation 10.3 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 12: 1 H Postdose | -1.2 beats per minute (beats/min) | Standard Deviation 16.61 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 13: Predose | 0.2 beats per minute (beats/min) | Standard Deviation 16.69 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 13: 1 H Postdose | 2.9 beats per minute (beats/min) | Standard Deviation 13.76 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 14: Predose | -3.7 beats per minute (beats/min) | Standard Deviation 15.16 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 14: 1 H Postdose | -2.2 beats per minute (beats/min) | Standard Deviation 17.24 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Day 15/ET | -3.5 beats per minute (beats/min) | Standard Deviation 16.06 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Follow-up Day 21 | -6.5 beats per minute (beats/min) | Standard Deviation 17.66 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part A | CFB at Follow-up Day 28 | -6.8 beats per minute (beats/min) | Standard Deviation 13.53 |
Primary
Change From Baseline (CFB) in Oral Temperature - Part A
Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination.
Time frame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | Baseline | 36.71 degrees Celsius (degrees C) | Standard Deviation 0.278 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 1: 0.25 H Postdose | -0.17 degrees Celsius (degrees C) | Standard Deviation 0.457 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 1: 0.5 H Postdose | 0.12 degrees Celsius (degrees C) | Standard Deviation 0.302 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 1: 1 H Postdose | 0.11 degrees Celsius (degrees C) | Standard Deviation 0.468 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 1: 2 H Postdose | 0.03 degrees Celsius (degrees C) | Standard Deviation 0.438 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 1: 12 H Postdose | -0.09 degrees Celsius (degrees C) | Standard Deviation 0.433 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 2: Predose | -0.05 degrees Celsius (degrees C) | Standard Deviation 0.41 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 2: 0.25 H Postdose | 0.04 degrees Celsius (degrees C) | Standard Deviation 0.532 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 2: 0.5 H Postdose | 0.00 degrees Celsius (degrees C) | Standard Deviation 0.493 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 2: 1 H Postdose | 0.20 degrees Celsius (degrees C) | Standard Deviation 0.555 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 2: 2 H Postdose | 0.01 degrees Celsius (degrees C) | Standard Deviation 0.497 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 2: 12 H Postdose | -0.05 degrees Celsius (degrees C) | Standard Deviation 0.399 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 3: Predose | 0.02 degrees Celsius (degrees C) | Standard Deviation 0.58 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 3: 0.25 H Postdose | -0.08 degrees Celsius (degrees C) | Standard Deviation 0.563 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 3: 0.5 H Postdose | -0.17 degrees Celsius (degrees C) | Standard Deviation 0.497 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 3: 1 H Postdose | -0.02 degrees Celsius (degrees C) | Standard Deviation 0.597 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 3: 2 H Postdose | -0.11 degrees Celsius (degrees C) | Standard Deviation 0.459 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 3: 12 H Postdose | -0.22 degrees Celsius (degrees C) | Standard Deviation 0.389 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 4: Predose | -0.05 degrees Celsius (degrees C) | Standard Deviation 0.525 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 4: 0.25 H Postdose | 0.00 degrees Celsius (degrees C) | Standard Deviation 0.473 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 4: 0.5 H Postdose | 0.26 degrees Celsius (degrees C) | Standard Deviation 0.459 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 4: 1 H Postdose | -0.05 degrees Celsius (degrees C) | Standard Deviation 0.619 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 4: 2 H Postdose | -0.04 degrees Celsius (degrees C) | Standard Deviation 0.373 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 4: 12 H Postdose | -0.11 degrees Celsius (degrees C) | Standard Deviation 0.373 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 5: Predose | -0.06 degrees Celsius (degrees C) | Standard Deviation 0.498 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 5: 0.25 H Postdose | 0.01 degrees Celsius (degrees C) | Standard Deviation 0.35 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 5: 0.5 H Postdose | -0.05 degrees Celsius (degrees C) | Standard Deviation 0.418 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 5: 1 H Postdose | -0.08 degrees Celsius (degrees C) | Standard Deviation 0.458 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 5: 2 H Postdose | -0.18 degrees Celsius (degrees C) | Standard Deviation 0.523 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 5: 12 H Postdose | -0.09 degrees Celsius (degrees C) | Standard Deviation 0.499 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 6: Predose | 0.09 degrees Celsius (degrees C) | Standard Deviation 0.56 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 6: 0.25 H Postdose | 0.13 degrees Celsius (degrees C) | Standard Deviation 0.512 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 6: 0.5 H Postdose | -0.05 degrees Celsius (degrees C) | Standard Deviation 0.405 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 6: 1 H Postdose | 0.06 degrees Celsius (degrees C) | Standard Deviation 0.601 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 6: 2 H Postdose | -0.12 degrees Celsius (degrees C) | Standard Deviation 0.526 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 6: 12 H Postdose | -0.04 degrees Celsius (degrees C) | Standard Deviation 0.566 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 7: Predose | -0.11 degrees Celsius (degrees C) | Standard Deviation 0.722 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 7: 0.25 H Postdose | -0.11 degrees Celsius (degrees C) | Standard Deviation 0.566 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 7: 0.5 H Postdose | -0.08 degrees Celsius (degrees C) | Standard Deviation 0.639 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 7: 1 H Postdose | -0.14 degrees Celsius (degrees C) | Standard Deviation 0.588 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 7: 2 H Postdose | -0.02 degrees Celsius (degrees C) | Standard Deviation 0.453 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 7: 12 H Postdose | -0.10 degrees Celsius (degrees C) | Standard Deviation 0.534 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 8: Predose | -0.02 degrees Celsius (degrees C) | Standard Deviation 0.589 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 8: 1 H Postdose | 0.02 degrees Celsius (degrees C) | Standard Deviation 0.351 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 9: Predose | -0.28 degrees Celsius (degrees C) | Standard Deviation 0.675 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 9: 1 H Postdose | -0.17 degrees Celsius (degrees C) | Standard Deviation 0.609 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 10: Predose | -0.20 degrees Celsius (degrees C) | Standard Deviation 0.471 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 10: 1 H Postdose | -0.23 degrees Celsius (degrees C) | Standard Deviation 0.624 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 11: Predose | 0.03 degrees Celsius (degrees C) | Standard Deviation 0.483 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 11: 1 H Postdose | -0.28 degrees Celsius (degrees C) | Standard Deviation 0.506 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 12: Predose | -0.18 degrees Celsius (degrees C) | Standard Deviation 0.504 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 12: 1 H Postdose | -0.10 degrees Celsius (degrees C) | Standard Deviation 0.512 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 13: Predose | -0.12 degrees Celsius (degrees C) | Standard Deviation 0.448 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 13: 1 H Postdose | -0.23 degrees Celsius (degrees C) | Standard Deviation 0.342 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 14: Predose | 0.01 degrees Celsius (degrees C) | Standard Deviation 0.475 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 14: 1 H Postdose | 0.05 degrees Celsius (degrees C) | Standard Deviation 0.57 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Day 15/ET | -0.05 degrees Celsius (degrees C) | Standard Deviation 0.326 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Follow-up Day 21 | -0.10 degrees Celsius (degrees C) | Standard Deviation 0.372 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part A | CFB at Follow-up Day 28 | -0.12 degrees Celsius (degrees C) | Standard Deviation 0.326 |
Primary
Change From Baseline (CFB) in Oxygen Saturation - Part A
Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s).
Time frame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Day 8 (predose, 1 hour postdose)
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | Baseline | 98.6 percentage of oxygen saturation | Standard Deviation 1.08 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 1: 0.25 H Postdose | 0.0 percentage of oxygen saturation | Standard Deviation 1.65 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 1: 0.5 H Postdose | -0.4 percentage of oxygen saturation | Standard Deviation 2.02 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 1: 1 H Postdose | 0.3 percentage of oxygen saturation | Standard Deviation 1.22 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 1: 2 H Postdose | -0.3 percentage of oxygen saturation | Standard Deviation 2.16 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 1: 12 H Postdose | 0.3 percentage of oxygen saturation | Standard Deviation 1.07 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 2: Predose | -0.4 percentage of oxygen saturation | Standard Deviation 1.62 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 2: 0.25 H Postdose | -0.1 percentage of oxygen saturation | Standard Deviation 1.83 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 2: 0.5 H Postdose | -0.3 percentage of oxygen saturation | Standard Deviation 1.44 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 2: 1 H Postdose | 0.1 percentage of oxygen saturation | Standard Deviation 1.62 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 2: 2 H Postdose | -0.2 percentage of oxygen saturation | Standard Deviation 1.34 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 2: 12 H Postdose | -0.6 percentage of oxygen saturation | Standard Deviation 1.62 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 3: Predose | 0.3 percentage of oxygen saturation | Standard Deviation 1.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 3: 0.25 H Postdose | -0.9 percentage of oxygen saturation | Standard Deviation 1.68 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 3: 0.5 H Postdose | -1.3 percentage of oxygen saturation | Standard Deviation 2.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 3: 1 H Postdose | -0.3 percentage of oxygen saturation | Standard Deviation 1.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 3: 2 H Postdose | 0.1 percentage of oxygen saturation | Standard Deviation 1.37 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 3: 12 H Postdose | -0.9 percentage of oxygen saturation | Standard Deviation 1.68 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 4: Predose | -1.1 percentage of oxygen saturation | Standard Deviation 2.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 4: 0.25 H Postdose | -0.2 percentage of oxygen saturation | Standard Deviation 1.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 4: 0.5 H Postdose | -0.6 percentage of oxygen saturation | Standard Deviation 2.19 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 4: 1 H Postdose | -0.5 percentage of oxygen saturation | Standard Deviation 1.68 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 4: 2 H Postdose | -0.4 percentage of oxygen saturation | Standard Deviation 1.5 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 4: 12 H Postdose | -0.5 percentage of oxygen saturation | Standard Deviation 2.07 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 5: Predose | -0.4 percentage of oxygen saturation | Standard Deviation 1.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 5: 0.25 H Postdose | -0.6 percentage of oxygen saturation | Standard Deviation 2.11 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 5: 0.5 H Postdose | -0.2 percentage of oxygen saturation | Standard Deviation 1.53 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 5: 1 H Postdose | -0.5 percentage of oxygen saturation | Standard Deviation 1.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 5: 2 H Postdose | -0.7 percentage of oxygen saturation | Standard Deviation 2.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 5: 12 H Postdose | -0.2 percentage of oxygen saturation | Standard Deviation 1.34 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 6: Predose | -0.4 percentage of oxygen saturation | Standard Deviation 1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 6: 0.25 H Postdose | -0.5 percentage of oxygen saturation | Standard Deviation 1.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 6: 0.5 H Postdose | -0.5 percentage of oxygen saturation | Standard Deviation 1.98 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 6: 1 H Postdose | -0.3 percentage of oxygen saturation | Standard Deviation 0.97 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 6: 2 H Postdose | -0.3 percentage of oxygen saturation | Standard Deviation 1.22 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 6: 12 H Postdose | 0.3 percentage of oxygen saturation | Standard Deviation 1.42 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 7: Predose | -0.5 percentage of oxygen saturation | Standard Deviation 1.44 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 7: 0.25 H Postdose | -0.4 percentage of oxygen saturation | Standard Deviation 2.06 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 7: 0.5 H Postdose | -0.5 percentage of oxygen saturation | Standard Deviation 1.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 7: 1 H Postdose | -1.1 percentage of oxygen saturation | Standard Deviation 1.93 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 7: 2 H Postdose | -0.6 percentage of oxygen saturation | Standard Deviation 1.31 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 7: 12 H Postdose | -0.5 percentage of oxygen saturation | Standard Deviation 1.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 8: Predose | 0.2 percentage of oxygen saturation | Standard Deviation 1.53 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part A | CFB at Day 8: 1 H Postdose | -0.3 percentage of oxygen saturation | Standard Deviation 1.82 |
Primary
Change From Baseline (CFB) in Respiratory Rate - Part A
Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination.
Time frame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | Baseline | 16.9 breaths per minute (breaths/min) | Standard Deviation 1.75 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 1: 0.25 H Postdose | 0.5 breaths per minute (breaths/min) | Standard Deviation 1.45 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 1: 0.5 H Postdose | 0.5 breaths per minute (breaths/min) | Standard Deviation 1.45 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 1: 1 H Postdose | 0.3 breaths per minute (breaths/min) | Standard Deviation 1.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 1: 2 H Postdose | 0.4 breaths per minute (breaths/min) | Standard Deviation 1.57 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 1: 12 H Postdose | -0.1 breaths per minute (breaths/min) | Standard Deviation 1.26 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 2: Predose | 0.5 breaths per minute (breaths/min) | Standard Deviation 1.56 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 2: 0.25 H Postdose | 0.3 breaths per minute (breaths/min) | Standard Deviation 2.1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 2: 0.5 H Postdose | -0.1 breaths per minute (breaths/min) | Standard Deviation 1.66 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 2: 1 H Postdose | -0.2 breaths per minute (breaths/min) | Standard Deviation 1.72 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 2: 2 H Postdose | -0.5 breaths per minute (breaths/min) | Standard Deviation 1.66 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 2: 12 H Postdose | -0.5 breaths per minute (breaths/min) | Standard Deviation 1.71 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 3: Predose | -0.4 breaths per minute (breaths/min) | Standard Deviation 1.61 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 3: 0.25 H Postdose | 0.4 breaths per minute (breaths/min) | Standard Deviation 1.76 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 3: 0.5 H Postdose | -0.3 breaths per minute (breaths/min) | Standard Deviation 1.65 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 3: 1 H Postdose | -0.2 breaths per minute (breaths/min) | Standard Deviation 1.17 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 3: 2 H Postdose | -0.7 breaths per minute (breaths/min) | Standard Deviation 1.35 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 3: 12 H Postdose | -0.1 breaths per minute (breaths/min) | Standard Deviation 1.66 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 4: Predose | 0.1 breaths per minute (breaths/min) | Standard Deviation 1.55 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 4: 0.25 H Postdose | 0.3 breaths per minute (breaths/min) | Standard Deviation 1.55 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 4: 0.5 H Postdose | 0.3 breaths per minute (breaths/min) | Standard Deviation 1.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 4: 1 H Postdose | 0.5 breaths per minute (breaths/min) | Standard Deviation 1.2 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 4: 2 H Postdose | 0.3 breaths per minute (breaths/min) | Standard Deviation 1.67 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 4: 12 H Postdose | 0.4 breaths per minute (breaths/min) | Standard Deviation 1.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 5: Predose | 0.2 breaths per minute (breaths/min) | Standard Deviation 1.57 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 5: 0.25 H Postdose | 0.4 breaths per minute (breaths/min) | Standard Deviation 1.39 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 5: 0.5 H Postdose | 0.4 breaths per minute (breaths/min) | Standard Deviation 1.5 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 5: 1 H Postdose | 0.2 breaths per minute (breaths/min) | Standard Deviation 1.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 5: 2 H Postdose | -0.5 breaths per minute (breaths/min) | Standard Deviation 1.75 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 5: 12 H Postdose | -0.5 breaths per minute (breaths/min) | Standard Deviation 2.99 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 6: Predose | 0.2 breaths per minute (breaths/min) | Standard Deviation 1.83 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 6: 0.25 H Postdose | 0.2 breaths per minute (breaths/min) | Standard Deviation 1.83 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 6: 0.5 H Postdose | 0.1 breaths per minute (breaths/min) | Standard Deviation 1.89 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 6: 1 H Postdose | 0.1 breaths per minute (breaths/min) | Standard Deviation 1.55 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 6: 2 H Postdose | 0.1 breaths per minute (breaths/min) | Standard Deviation 2.1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 6: 12 H Postdose | -0.1 breaths per minute (breaths/min) | Standard Deviation 1.12 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 7: Predose | 0.1 breaths per minute (breaths/min) | Standard Deviation 1.55 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 7: 0.25 H Postdose | 0.8 breaths per minute (breaths/min) | Standard Deviation 1.99 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 7: 0.5 H Postdose | 0.2 breaths per minute (breaths/min) | Standard Deviation 0.83 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 7: 1 H Postdose | 0.5 breaths per minute (breaths/min) | Standard Deviation 1.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 7: 2 H Postdose | -0.1 breaths per minute (breaths/min) | Standard Deviation 2.02 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 7: 12 H Postdose | -0.3 breaths per minute (breaths/min) | Standard Deviation 2.53 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 8: Predose | 1.2 breaths per minute (breaths/min) | Standard Deviation 2.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 8: 1 H Postdose | -0.3 breaths per minute (breaths/min) | Standard Deviation 1.84 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 9: Predose | 0.5 breaths per minute (breaths/min) | Standard Deviation 2.18 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 9: 1 H Postdose | 0.5 breaths per minute (breaths/min) | Standard Deviation 2.67 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 10: Predose | 0.6 breaths per minute (breaths/min) | Standard Deviation 2.5 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 10: 1 H Postdose | 0.0 breaths per minute (breaths/min) | Standard Deviation 1.96 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 11: Predose | 0.8 breaths per minute (breaths/min) | Standard Deviation 1.95 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 11: 1 H Postdose | -0.2 breaths per minute (breaths/min) | Standard Deviation 1.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 12: Predose | 0.5 breaths per minute (breaths/min) | Standard Deviation 1.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 12: 1 H Postdose | 0.5 breaths per minute (breaths/min) | Standard Deviation 2.54 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 13: Predose | 0.3 breaths per minute (breaths/min) | Standard Deviation 2.39 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 13: 1 H Postdose | 0.5 breaths per minute (breaths/min) | Standard Deviation 1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 14: Predose | 0.3 breaths per minute (breaths/min) | Standard Deviation 1.55 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 14: 1 H Postdose | 0.0 breaths per minute (breaths/min) | Standard Deviation 2.12 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Day 15/ET | 0.1 breaths per minute (breaths/min) | Standard Deviation 2.1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Follow-up Day 21 | 0.8 breaths per minute (breaths/min) | Standard Deviation 1.92 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part A | CFB at Follow-up Day 28 | 0.3 breaths per minute (breaths/min) | Standard Deviation 1.6 |
Primary
Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A
Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination.
Time frame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | Baseline | 83.9 mmHg | Standard Deviation 8.17 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 1: 0.25 H Postdose | -0.2 mmHg | Standard Deviation 7.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 1: 0.5 H Postdose | -1.5 mmHg | Standard Deviation 6.33 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 1: 1 H Postdose | -1.8 mmHg | Standard Deviation 5.1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 1: 2 H Postdose | -1.5 mmHg | Standard Deviation 9.13 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 1: 12 H Postdose | -3.5 mmHg | Standard Deviation 7.49 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 2: Predose | -4.9 mmHg | Standard Deviation 5.41 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 2: 0.25 H Postdose | -3.3 mmHg | Standard Deviation 9.53 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 2: 0.5 H Postdose | -1.8 mmHg | Standard Deviation 7.46 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 2: 1 H Postdose | -3.4 mmHg | Standard Deviation 9.9 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 2: 2 H Postdose | -5.8 mmHg | Standard Deviation 9.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 2: 12 H Postdose | -3.2 mmHg | Standard Deviation 13.06 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 3: Predose | -4.2 mmHg | Standard Deviation 13.31 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 3: 0.25 H Postdose | -3.6 mmHg | Standard Deviation 10.79 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 3: 0.5 H Postdose | -1.9 mmHg | Standard Deviation 9.84 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 3: 1 H Postdose | -0.8 mmHg | Standard Deviation 9.58 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 3: 2 H Postdose | -2.2 mmHg | Standard Deviation 13.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 3: 12 H Postdose | 0.7 mmHg | Standard Deviation 10.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 4: Predose | -0.8 mmHg | Standard Deviation 13.05 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 4: 0.25 H Postdose | -1.4 mmHg | Standard Deviation 10.91 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 4: 0.5 H Postdose | -2.6 mmHg | Standard Deviation 11 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 4: 1 H Postdose | -3.3 mmHg | Standard Deviation 9.02 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 4: 2 H Postdose | -2.9 mmHg | Standard Deviation 10.16 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 4: 12 H Postdose | -2.6 mmHg | Standard Deviation 12.31 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 5: Predose | -2.1 mmHg | Standard Deviation 10.54 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 5: 0.25 H Postdose | -2.6 mmHg | Standard Deviation 11.99 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 5: 0.5 H Postdose | -5.3 mmHg | Standard Deviation 10.71 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 5: 1 H Postdose | -5.9 mmHg | Standard Deviation 13.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 5: 2 H Postdose | -5.4 mmHg | Standard Deviation 13.26 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 5: 12 H Postdose | -2.2 mmHg | Standard Deviation 12.98 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 6: Predose | -2.2 mmHg | Standard Deviation 10.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 6: 0.25 H Postdose | -0.9 mmHg | Standard Deviation 9.27 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 6: 0.5 H Postdose | 1.2 mmHg | Standard Deviation 7.97 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 6: 1 H Postdose | -1.8 mmHg | Standard Deviation 9.08 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 6: 2 H Postdose | -2.6 mmHg | Standard Deviation 6.7 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 6: 12 H Postdose | -4.5 mmHg | Standard Deviation 9.75 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 7: Predose | -0.2 mmHg | Standard Deviation 14.31 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 7: 0.25 H Postdose | 0.8 mmHg | Standard Deviation 9.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 7: 0.5 H Postdose | -0.4 mmHg | Standard Deviation 12.76 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 7: 1 H Postdose | -2.5 mmHg | Standard Deviation 11.33 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 7: 2 H Postdose | -2.4 mmHg | Standard Deviation 7.97 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 7: 12 H Postdose | -3.0 mmHg | Standard Deviation 8.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 8: Predose | 1.3 mmHg | Standard Deviation 9.91 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 8: 1 H Postdose | -4.5 mmHg | Standard Deviation 11.97 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 9: Predose | -2.5 mmHg | Standard Deviation 10.83 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 9: 1 H Postdose | -4.2 mmHg | Standard Deviation 10.61 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 10: Predose | -2.0 mmHg | Standard Deviation 9.7 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 10: 1 H Postdose | -3.7 mmHg | Standard Deviation 9.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 11: Predose | 2.0 mmHg | Standard Deviation 9.03 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 11: 1 H Postdose | -7.1 mmHg | Standard Deviation 8.61 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 12: Predose | -3.8 mmHg | Standard Deviation 10.4 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 12: 1 H Postdose | -2.5 mmHg | Standard Deviation 10.62 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 13: Predose | 0.5 mmHg | Standard Deviation 4.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 13: 1 H Postdose | 1.4 mmHg | Standard Deviation 7.08 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 14: Predose | -0.7 mmHg | Standard Deviation 9.76 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 14: 1 H Postdose | -3.2 mmHg | Standard Deviation 9.24 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Day 15/ET | 0.5 mmHg | Standard Deviation 8.39 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Follow-up Day 21 | 0.8 mmHg | Standard Deviation 10.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part A | CFB at Follow-up Day 28 | 1.7 mmHg | Standard Deviation 6.8 |
Primary
Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A
Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination.
Time frame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | Baseline | 126.8 mmHg | Standard Deviation 15.09 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 1: 0.25 H Postdose | -0.1 mmHg | Standard Deviation 9.67 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 1: 0.5 H Postdose | -3.8 mmHg | Standard Deviation 8.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 1: 1 H Postdose | -6.5 mmHg | Standard Deviation 10.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 1: 2 H Postdose | -3.9 mmHg | Standard Deviation 8.9 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 1: 12 H Postdose | -4.2 mmHg | Standard Deviation 10.4 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 2: Predose | -3.5 mmHg | Standard Deviation 11.74 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 2: 0.25 H Postdose | -0.9 mmHg | Standard Deviation 15.14 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 2: 0.5 H Postdose | -1.2 mmHg | Standard Deviation 11.29 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 2: 1 H Postdose | -3.8 mmHg | Standard Deviation 13.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 2: 2 H Postdose | -3.2 mmHg | Standard Deviation 14.52 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 2: 12 H Postdose | -1.7 mmHg | Standard Deviation 13.68 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 3: Predose | -0.5 mmHg | Standard Deviation 9.57 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 3: 0.25 H Postdose | -0.4 mmHg | Standard Deviation 12.39 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 3: 0.5 H Postdose | -1.2 mmHg | Standard Deviation 15.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 3: 1 H Postdose | -0.6 mmHg | Standard Deviation 15.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 3: 2 H Postdose | 3.3 mmHg | Standard Deviation 16.41 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 3: 12 H Postdose | -1.0 mmHg | Standard Deviation 15.56 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 4: Predose | -1.1 mmHg | Standard Deviation 15.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 4: 0.25 H Postdose | 0.4 mmHg | Standard Deviation 13.26 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 4: 0.5 H Postdose | -0.8 mmHg | Standard Deviation 13.55 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 4: 1 H Postdose | -0.8 mmHg | Standard Deviation 14.81 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 4: 2 H Postdose | -5.8 mmHg | Standard Deviation 13.5 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 4: 12 H Postdose | -7.1 mmHg | Standard Deviation 20.47 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 5: Predose | -3.8 mmHg | Standard Deviation 16.67 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 5: 0.25 H Postdose | -1.9 mmHg | Standard Deviation 16.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 5: 0.5 H Postdose | -7.0 mmHg | Standard Deviation 15.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 5: 1 H Postdose | -7.4 mmHg | Standard Deviation 13.74 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 5: 2 H Postdose | -4.4 mmHg | Standard Deviation 10.26 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 5: 12 H Postdose | -7.2 mmHg | Standard Deviation 17.29 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 6: Predose | -3.7 mmHg | Standard Deviation 16.2 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 6: 0.25 H Postdose | 1.2 mmHg | Standard Deviation 12.65 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 6: 0.5 H Postdose | 0.3 mmHg | Standard Deviation 11.73 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 6: 1 H Postdose | -3.2 mmHg | Standard Deviation 15.96 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 6: 2 H Postdose | -7.1 mmHg | Standard Deviation 12.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 6: 12 H Postdose | -5.6 mmHg | Standard Deviation 17.41 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 7: Predose | -2.2 mmHg | Standard Deviation 21.07 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 7: 0.25 H Postdose | -1.8 mmHg | Standard Deviation 12.25 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 7: 0.5 H Postdose | -1.0 mmHg | Standard Deviation 19.46 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 7: 1 H Postdose | -6.8 mmHg | Standard Deviation 12.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 7: 2 H Postdose | -3.6 mmHg | Standard Deviation 11.35 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 7: 12 H Postdose | -5.5 mmHg | Standard Deviation 14.01 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 8: Predose | 1.5 mmHg | Standard Deviation 12.27 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 8: 1 H Postdose | -6.6 mmHg | Standard Deviation 12.91 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 9: Predose | -0.9 mmHg | Standard Deviation 12.05 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 9: 1 H Postdose | -1.9 mmHg | Standard Deviation 15.18 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 10: Predose | 2.8 mmHg | Standard Deviation 15.82 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 10: 1 H Postdose | -4.0 mmHg | Standard Deviation 14.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 11: Predose | 5.9 mmHg | Standard Deviation 13.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 11: 1 H Postdose | -4.9 mmHg | Standard Deviation 10.18 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 12: Predose | 4.1 mmHg | Standard Deviation 19.31 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 12: 1 H Postdose | -3.8 mmHg | Standard Deviation 19.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 13: Predose | 0.5 mmHg | Standard Deviation 14.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 13: 1 H Postdose | 0.8 mmHg | Standard Deviation 13.04 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 14: Predose | -0.8 mmHg | Standard Deviation 12.19 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 14: 1 H Postdose | -8.9 mmHg | Standard Deviation 12.53 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Day 15/ET | -1.4 mmHg | Standard Deviation 11.39 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Follow-up Day 21 | 7.8 mmHg | Standard Deviation 14.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part A | CFB at Follow-up Day 28 | 3.8 mmHg | Standard Deviation 13.53 |
Primary
Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A
Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination.
Time frame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | Baseline | 79.4 mmHg | Standard Deviation 8.84 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 1: 0.25 H Postdose | -1.1 mmHg | Standard Deviation 5.5 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 1: 0.5 H Postdose | -1.6 mmHg | Standard Deviation 6.27 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 1: 1 H Postdose | -2.0 mmHg | Standard Deviation 7.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 1: 2 H Postdose | -5.2 mmHg | Standard Deviation 11.69 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 1: 12 H Postdose | 1.3 mmHg | Standard Deviation 7.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 2: Predose | -3.5 mmHg | Standard Deviation 9.4 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 2: 0.25 H Postdose | -0.2 mmHg | Standard Deviation 8.36 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 2: 0.5 H Postdose | -2.4 mmHg | Standard Deviation 7.84 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 2: 1 H Postdose | -2.5 mmHg | Standard Deviation 10.52 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 2: 2 H Postdose | -5.4 mmHg | Standard Deviation 11.14 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 2: 12 H Postdose | -2.4 mmHg | Standard Deviation 7.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 3: Predose | 0.3 mmHg | Standard Deviation 6.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 3: 0.25 H Postdose | 1.9 mmHg | Standard Deviation 10.33 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 3: 0.5 H Postdose | 0.2 mmHg | Standard Deviation 9.12 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 3: 1 H Postdose | -0.2 mmHg | Standard Deviation 9.13 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 3: 2 H Postdose | -3.9 mmHg | Standard Deviation 10.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 3: 12 H Postdose | 0.0 mmHg | Standard Deviation 9.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 4: Predose | -0.8 mmHg | Standard Deviation 10.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 4: 0.25 H Postdose | -1.1 mmHg | Standard Deviation 12.13 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 4: 0.5 H Postdose | 0.1 mmHg | Standard Deviation 14.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 4: 1 H Postdose | -3.5 mmHg | Standard Deviation 12.03 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 4: 2 H Postdose | -2.3 mmHg | Standard Deviation 10.27 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 4: 12 H Postdose | -1.1 mmHg | Standard Deviation 13.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 5: Predose | -1.3 mmHg | Standard Deviation 13.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 5: 0.25 H Postdose | -1.5 mmHg | Standard Deviation 11.49 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 5: 0.5 H Postdose | -1.3 mmHg | Standard Deviation 12.14 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 5: 1 H Postdose | -6.0 mmHg | Standard Deviation 12.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 5: 2 H Postdose | -4.3 mmHg | Standard Deviation 12.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 5: 12 H Postdose | -1.1 mmHg | Standard Deviation 10.16 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 6: Predose | -2.6 mmHg | Standard Deviation 12.05 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 6: 0.25 H Postdose | -0.8 mmHg | Standard Deviation 10.38 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 6: 0.5 H Postdose | 1.8 mmHg | Standard Deviation 10.3 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 6: 1 H Postdose | 0.8 mmHg | Standard Deviation 11.96 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 6: 2 H Postdose | -0.8 mmHg | Standard Deviation 13.04 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 6: 12 H Postdose | -2.5 mmHg | Standard Deviation 14.08 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 7: Predose | 2.2 mmHg | Standard Deviation 13.53 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 7: 0.25 H Postdose | 2.0 mmHg | Standard Deviation 11.31 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 7: 0.5 H Postdose | 0.2 mmHg | Standard Deviation 10.39 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 7: 1 H Postdose | -0.2 mmHg | Standard Deviation 12.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 7: 2 H Postdose | -1.8 mmHg | Standard Deviation 9.16 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 7: 12 H Postdose | -2.5 mmHg | Standard Deviation 8.27 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 8: Predose | 2.3 mmHg | Standard Deviation 11.27 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 8: 1 H Postdose | -2.9 mmHg | Standard Deviation 9.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 9: Predose | 3.2 mmHg | Standard Deviation 11.91 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 9: 1 H Postdose | 0.5 mmHg | Standard Deviation 11.72 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 10: Predose | 1.6 mmHg | Standard Deviation 10.02 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 10: 1 H Postdose | -3.7 mmHg | Standard Deviation 9.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 11: Predose | 5.2 mmHg | Standard Deviation 10.54 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 11: 1 H Postdose | 0.0 mmHg | Standard Deviation 9.41 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 12: Predose | 0.4 mmHg | Standard Deviation 8.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 12: 1 H Postdose | 2.1 mmHg | Standard Deviation 12.11 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 13: Predose | 3.2 mmHg | Standard Deviation 9.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 13: 1 H Postdose | 3.7 mmHg | Standard Deviation 8.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 14: Predose | -1.3 mmHg | Standard Deviation 10.16 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 14: 1 H Postdose | -0.2 mmHg | Standard Deviation 9.08 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Day 15/ET | -0.7 mmHg | Standard Deviation 8.73 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Follow-up Day 21 | 3.1 mmHg | Standard Deviation 10.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part A | CFB at Follow-up Day 28 | 1.8 mmHg | Standard Deviation 11.26 |
Primary
Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A
Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part A of the study. H = Hour(s). ET = Early Termination.
Time frame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | Baseline | 122.8 millimeter of mercury (mmHg) | Standard Deviation 15.92 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 1: 0.25 H Postdose | -1.7 millimeter of mercury (mmHg) | Standard Deviation 10.82 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 1: 0.5 H Postdose | -4.2 millimeter of mercury (mmHg) | Standard Deviation 9.5 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 1: 1 H Postdose | -2.4 millimeter of mercury (mmHg) | Standard Deviation 13.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 1: 2 H Postdose | -4.9 millimeter of mercury (mmHg) | Standard Deviation 13.47 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 1: 12 H Postdose | -0.8 millimeter of mercury (mmHg) | Standard Deviation 12.12 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 2: Predose | -0.8 millimeter of mercury (mmHg) | Standard Deviation 17.66 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 2: 0.25 H Postdose | 8.2 millimeter of mercury (mmHg) | Standard Deviation 17.46 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 2: 0.5 H Postdose | 0.8 millimeter of mercury (mmHg) | Standard Deviation 16.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 2: 1 H Postdose | 2.3 millimeter of mercury (mmHg) | Standard Deviation 16.65 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 2: 2 H Postdose | -4.7 millimeter of mercury (mmHg) | Standard Deviation 13.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 2: 12 H Postdose | -0.5 millimeter of mercury (mmHg) | Standard Deviation 12.01 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 3: Predose | -2.1 millimeter of mercury (mmHg) | Standard Deviation 14.33 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 3: 0.25 H Postdose | 5.8 millimeter of mercury (mmHg) | Standard Deviation 15.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 3: 0.5 H Postdose | 0.5 millimeter of mercury (mmHg) | Standard Deviation 17.08 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 3: 1 H Postdose | 2.5 millimeter of mercury (mmHg) | Standard Deviation 13.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 3: 2 H Postdose | -0.8 millimeter of mercury (mmHg) | Standard Deviation 16.49 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 3: 12 H Postdose | 1.7 millimeter of mercury (mmHg) | Standard Deviation 12.98 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 4: Predose | -0.5 millimeter of mercury (mmHg) | Standard Deviation 17.7 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 4: 0.25 H Postdose | -0.4 millimeter of mercury (mmHg) | Standard Deviation 15.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 4: 0.5 H Postdose | 1.8 millimeter of mercury (mmHg) | Standard Deviation 18.69 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 4: 1 H Postdose | -0.4 millimeter of mercury (mmHg) | Standard Deviation 19.35 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 4: 2 H Postdose | -3.4 millimeter of mercury (mmHg) | Standard Deviation 13.58 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 4: 12 H Postdose | -2.7 millimeter of mercury (mmHg) | Standard Deviation 18.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 5: Predose | -0.1 millimeter of mercury (mmHg) | Standard Deviation 20.01 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 5: 0.25 H Postdose | 3.1 millimeter of mercury (mmHg) | Standard Deviation 18.18 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 5: 0.5 H Postdose | 0.3 millimeter of mercury (mmHg) | Standard Deviation 16.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 5: 1 H Postdose | -4.8 millimeter of mercury (mmHg) | Standard Deviation 20.99 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 5: 2 H Postdose | -2.9 millimeter of mercury (mmHg) | Standard Deviation 16.11 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 5: 12 H Postdose | -1.5 millimeter of mercury (mmHg) | Standard Deviation 15.9 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 6: Predose | -0.2 millimeter of mercury (mmHg) | Standard Deviation 15.95 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 6: 0.25 H Postdose | -0.2 millimeter of mercury (mmHg) | Standard Deviation 17.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 6: 0.5 H Postdose | 1.8 millimeter of mercury (mmHg) | Standard Deviation 14.62 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 6: 1 H Postdose | 0.9 millimeter of mercury (mmHg) | Standard Deviation 15.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 6: 2 H Postdose | -3.5 millimeter of mercury (mmHg) | Standard Deviation 16.79 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 6: 12 H Postdose | -1.9 millimeter of mercury (mmHg) | Standard Deviation 22.35 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 7: Predose | -1.2 millimeter of mercury (mmHg) | Standard Deviation 21.17 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 7: 0.25 H Postdose | 4.0 millimeter of mercury (mmHg) | Standard Deviation 16.4 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 7: 0.5 H Postdose | 1.5 millimeter of mercury (mmHg) | Standard Deviation 17.47 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 7: 1 H Postdose | -3.2 millimeter of mercury (mmHg) | Standard Deviation 19.95 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 7: 2 H Postdose | 0.3 millimeter of mercury (mmHg) | Standard Deviation 13.45 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 7: 12 H Postdose | -4.3 millimeter of mercury (mmHg) | Standard Deviation 13.04 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 8: Predose | 4.3 millimeter of mercury (mmHg) | Standard Deviation 17.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 8: 1 H Postdose | -4.5 millimeter of mercury (mmHg) | Standard Deviation 13.15 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 9: Predose | 9.4 millimeter of mercury (mmHg) | Standard Deviation 15.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 9: 1 H Postdose | 3.3 millimeter of mercury (mmHg) | Standard Deviation 15.54 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 10: Predose | 8.4 millimeter of mercury (mmHg) | Standard Deviation 14.93 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 10: 1 H Postdose | 2.4 millimeter of mercury (mmHg) | Standard Deviation 14.19 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 11: Predose | 8.8 millimeter of mercury (mmHg) | Standard Deviation 19.16 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 11: 1 H Postdose | -1.7 millimeter of mercury (mmHg) | Standard Deviation 14.26 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 12: Predose | 7.4 millimeter of mercury (mmHg) | Standard Deviation 16.59 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 12: 1 H Postdose | -0.2 millimeter of mercury (mmHg) | Standard Deviation 18.93 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 13: Predose | 3.2 millimeter of mercury (mmHg) | Standard Deviation 19.62 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 13: 1 H Postdose | 1.3 millimeter of mercury (mmHg) | Standard Deviation 16.31 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 14: Predose | -3.8 millimeter of mercury (mmHg) | Standard Deviation 18.2 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 14: 1 H Postdose | -3.9 millimeter of mercury (mmHg) | Standard Deviation 15.01 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Day 15/ET | 3.8 millimeter of mercury (mmHg) | Standard Deviation 17.1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Follow-up Day 21 | 3.9 millimeter of mercury (mmHg) | Standard Deviation 10.84 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part A | CFB at Follow-up Day 28 | 7.3 millimeter of mercury (mmHg) | Standard Deviation 15.19 |
Primary
Change From Baseline in Activated Partial Thromboplastin Time - Part A
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part A | Baseline | 28.00 seconds |
| Part A: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part A | Change from Baseline at Day 8 | 1.00 seconds |
| Part A: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part A | Change from Baseline at Day 15/ET | 1.20 seconds |
| Part A: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part A | Change from Baseline at Follow-up Day 21 | 0.70 seconds |
| Part A: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part A | Change from Baseline at Follow-up Day 28 | 1.00 seconds |
Primary
Change From Baseline in Alanine Aminotransferase - Part A
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part A | Baseline | 18.8 U/L | Standard Deviation 10.85 |
| Part A: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part A | Change from Baseline at Day 8 | 8.8 U/L | Standard Deviation 11.31 |
| Part A: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part A | Change from Baseline at Day 15/ET | 11.0 U/L | Standard Deviation 21.63 |
| Part A: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part A | Change from Baseline at Follow-up Day 21 | 2.8 U/L | Standard Deviation 7.73 |
| Part A: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part A | Change from Baseline at Follow-up Day 28 | -1.7 U/L | Standard Deviation 9.39 |
Primary
Change From Baseline in Albumin - Part A
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Albumin - Part A | Baseline | 42.8 g/L | Standard Deviation 2.82 |
| Part A: SAGE-217 | Change From Baseline in Albumin - Part A | Change from Baseline at Day 8 | -1.5 g/L | Standard Deviation 2.07 |
| Part A: SAGE-217 | Change From Baseline in Albumin - Part A | Change from Baseline at Day 15/ET | -1.0 g/L | Standard Deviation 2.45 |
| Part A: SAGE-217 | Change From Baseline in Albumin - Part A | Change from Baseline at Follow-up Day 21 | -1.5 g/L | Standard Deviation 2.57 |
| Part A: SAGE-217 | Change From Baseline in Albumin - Part A | Change from Baseline at Follow-up Day 28 | -0.8 g/L | Standard Deviation 2.34 |
Primary
Change From Baseline in Alkaline Phosphatase - Part A
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part A | Baseline | 84.3 units per liter (U/L) | Standard Deviation 43.15 |
| Part A: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part A | Change from Baseline at Day 8 | 6.1 units per liter (U/L) | Standard Deviation 20.73 |
| Part A: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part A | Change from Baseline at Day 15/ET | 16.5 units per liter (U/L) | Standard Deviation 30.62 |
| Part A: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part A | Change from Baseline at Follow-up Day 21 | 2.3 units per liter (U/L) | Standard Deviation 9.93 |
| Part A: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part A | Change from Baseline at Follow-up Day 28 | 2.5 units per liter (U/L) | Standard Deviation 10.34 |
Primary
Change From Baseline in Aspartate Aminotransferase - Part A
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part A | Baseline | 18.7 U/L | Standard Deviation 8.07 |
| Part A: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part A | Change from Baseline at Day 8 | 3.7 U/L | Standard Deviation 8.63 |
| Part A: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part A | Change from Baseline at Day 15/ET | 5.7 U/L | Standard Deviation 17.5 |
| Part A: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part A | Change from Baseline at Follow-up Day 21 | 0.0 U/L | Standard Deviation 7.59 |
| Part A: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part A | Change from Baseline at Follow-up Day 28 | 0.5 U/L | Standard Deviation 12.6 |
Primary
Change From Baseline in Basophils - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Basophils - Part A | Baseline | 0.032 10^9 cells per liter (10^9 cells/L) | Standard Deviation 0.0286 |
| Part A: SAGE-217 | Change From Baseline in Basophils - Part A | Change from Baseline at Day 8 | -0.002 10^9 cells per liter (10^9 cells/L) | Standard Deviation 0.0388 |
| Part A: SAGE-217 | Change From Baseline in Basophils - Part A | Change from Baseline at Day 15/ET | 0.005 10^9 cells per liter (10^9 cells/L) | Standard Deviation 0.0445 |
| Part A: SAGE-217 | Change From Baseline in Basophils - Part A | Change from Baseline at Follow-up Day 21 | -0.003 10^9 cells per liter (10^9 cells/L) | Standard Deviation 0.0273 |
| Part A: SAGE-217 | Change From Baseline in Basophils - Part A | Change from Baseline at Follow-up Day 28 | -0.007 10^9 cells per liter (10^9 cells/L) | Standard Deviation 0.0244 |
Primary
Change From Baseline in Basophils to Leukocytes Ratio [Percentage (%)] - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as International System (SI) unit, percentage (%).
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio [Percentage (%)] - Part A | Baseline | 0.56 percentage | Standard Deviation 0.323 |
| Part A: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio [Percentage (%)] - Part A | Change from Baseline at Day 8 | 0.38 percentage | Standard Deviation 1.308 |
| Part A: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio [Percentage (%)] - Part A | Change from Baseline at Day 15/ET | 0.13 percentage | Standard Deviation 0.681 |
| Part A: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio [Percentage (%)] - Part A | Change from Baseline at Follow-up Day 21 | 0.02 percentage | Standard Deviation 0.453 |
| Part A: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio [Percentage (%)] - Part A | Change from Baseline at Follow-up Day 28 | -0.05 percentage | Standard Deviation 0.31 |
Primary
Change From Baseline in Bilirubin - Part A
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Bilirubin - Part A | Baseline | 8.945 micro-moles per liter (umol/L) | Standard Deviation 4.586 |
| Part A: SAGE-217 | Change From Baseline in Bilirubin - Part A | Change from Baseline at Day 8 | -1.052 micro-moles per liter (umol/L) | Standard Deviation 2.5687 |
| Part A: SAGE-217 | Change From Baseline in Bilirubin - Part A | Change from Baseline at Day 15/ET | -1.973 micro-moles per liter (umol/L) | Standard Deviation 2.9491 |
| Part A: SAGE-217 | Change From Baseline in Bilirubin - Part A | Change from Baseline at Follow-up Day 21 | -1.842 micro-moles per liter (umol/L) | Standard Deviation 3.7243 |
| Part A: SAGE-217 | Change From Baseline in Bilirubin - Part A | Change from Baseline at Follow-up Day 28 | -1.184 micro-moles per liter (umol/L) | Standard Deviation 2.7382 |
Primary
Change From Baseline in Carbon Dioxide - Part A
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Carbon Dioxide - Part A | Baseline | 26.4 mmol/L | Standard Deviation 2.5 |
| Part A: SAGE-217 | Change From Baseline in Carbon Dioxide - Part A | Change from Baseline at Day 8 | -1.0 mmol/L | Standard Deviation 2.35 |
| Part A: SAGE-217 | Change From Baseline in Carbon Dioxide - Part A | Change from Baseline at Day 15/ET | -0.8 mmol/L | Standard Deviation 1.63 |
| Part A: SAGE-217 | Change From Baseline in Carbon Dioxide - Part A | Change from Baseline at Follow-up Day 21 | 0.0 mmol/L | Standard Deviation 2.24 |
| Part A: SAGE-217 | Change From Baseline in Carbon Dioxide - Part A | Change from Baseline at Follow-up Day 28 | -0.5 mmol/L | Standard Deviation 1.56 |
Primary
Change From Baseline in Chloride - Part A
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Chloride - Part A | Baseline | 102.9 milli-moles per liter (mmol/L) | Standard Deviation 3.07 |
| Part A: SAGE-217 | Change From Baseline in Chloride - Part A | Change from Baseline at Day 8 | 1.2 milli-moles per liter (mmol/L) | Standard Deviation 2.55 |
| Part A: SAGE-217 | Change From Baseline in Chloride - Part A | Change from Baseline at Day 15/ET | 1.5 milli-moles per liter (mmol/L) | Standard Deviation 2.96 |
| Part A: SAGE-217 | Change From Baseline in Chloride - Part A | Change from Baseline at Follow-up Day 21 | 1.3 milli-moles per liter (mmol/L) | Standard Deviation 1.97 |
| Part A: SAGE-217 | Change From Baseline in Chloride - Part A | Change from Baseline at Follow-up Day 28 | 1.1 milli-moles per liter (mmol/L) | Standard Deviation 2.1 |
Primary
Change From Baseline in Creatinine - Part A
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Creatinine - Part A | Baseline | 73.848 umol/L | Standard Deviation 18.2228 |
| Part A: SAGE-217 | Change From Baseline in Creatinine - Part A | Change from Baseline at Day 8 | -0.748 umol/L | Standard Deviation 6.7791 |
| Part A: SAGE-217 | Change From Baseline in Creatinine - Part A | Change from Baseline at Day 15/ET | 0.136 umol/L | Standard Deviation 8.4394 |
| Part A: SAGE-217 | Change From Baseline in Creatinine - Part A | Change from Baseline at Follow-up Day 21 | 0.952 umol/L | Standard Deviation 9.4279 |
| Part A: SAGE-217 | Change From Baseline in Creatinine - Part A | Change from Baseline at Follow-up Day 28 | 0.816 umol/L | Standard Deviation 7.6084 |
Primary
Change From Baseline in ECG Mean Heart Rate - Part A
ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study.
Time frame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part A | Baseline | 65.6 beats/min | Standard Deviation 7.74 |
| Part A: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part A | Change from Baseline at Day 1 | 5.8 beats/min | Standard Deviation 7.83 |
| Part A: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part A | Change from Baseline at Day 2 | 5.6 beats/min | Standard Deviation 7.05 |
| Part A: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part A | Change from Baseline at Day 7 | 8.8 beats/min | Standard Deviation 9.72 |
| Part A: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part A | Change from Baseline at Day 14 | 6.0 beats/min | Standard Deviation 10.79 |
| Part A: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part A | Change from Baseline at Follow-up Day 21 | 7.0 beats/min | Standard Deviation 6.06 |
Primary
Change From Baseline in Eosinophils - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Eosinophils - Part A | Baseline | 0.155 10^9 cells/L | Standard Deviation 0.099 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils - Part A | Change from Baseline at Day 8 | 0.031 10^9 cells/L | Standard Deviation 0.0749 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils - Part A | Change from Baseline at Day 15/ET | 0.044 10^9 cells/L | Standard Deviation 0.0906 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils - Part A | Change from Baseline at Follow-up Day 21 | 0.018 10^9 cells/L | Standard Deviation 0.0796 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils - Part A | Change from Baseline at Follow-up Day 28 | 0.011 10^9 cells/L | Standard Deviation 0.103 |
Primary
Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part A | Baseline | 2.20 percentage | Standard Deviation 1.155 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part A | Change from Baseline at Day 8 | 0.68 percentage | Standard Deviation 1.174 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part A | Change from Baseline at Day 15/ET | 0.98 percentage | Standard Deviation 1.438 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part A | Change from Baseline at Follow-up Day 21 | 0.52 percentage | Standard Deviation 1.382 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part A | Change from Baseline at Follow-up Day 28 | 0.43 percentage | Standard Deviation 1.865 |
Primary
Change From Baseline in Erythrocytes - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Erythrocytes - Part A | Baseline | 4.661 10^12 cells per liter (10^12 cells/L) | Standard Deviation 0.4521 |
| Part A: SAGE-217 | Change From Baseline in Erythrocytes - Part A | Change from Baseline at Day 8 | 0.021 10^12 cells per liter (10^12 cells/L) | Standard Deviation 0.1406 |
| Part A: SAGE-217 | Change From Baseline in Erythrocytes - Part A | Change from Baseline at Day 15/ET | -0.050 10^12 cells per liter (10^12 cells/L) | Standard Deviation 0.192 |
| Part A: SAGE-217 | Change From Baseline in Erythrocytes - Part A | Change from Baseline at Follow-up Day 21 | -0.198 10^12 cells per liter (10^12 cells/L) | Standard Deviation 0.2302 |
| Part A: SAGE-217 | Change From Baseline in Erythrocytes - Part A | Change from Baseline at Follow-up Day 28 | -0.164 10^12 cells per liter (10^12 cells/L) | Standard Deviation 0.2382 |
Primary
Change From Baseline in Hematocrit - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Hematocrit - Part A | Baseline | 0.419 fraction of one | Standard Deviation 0.0341 |
| Part A: SAGE-217 | Change From Baseline in Hematocrit - Part A | Change from Baseline at Day 8 | 0.001 fraction of one | Standard Deviation 0.0123 |
| Part A: SAGE-217 | Change From Baseline in Hematocrit - Part A | Change from Baseline at Day 15/ET | -0.006 fraction of one | Standard Deviation 0.0203 |
| Part A: SAGE-217 | Change From Baseline in Hematocrit - Part A | Change from Baseline at Follow-up Day 21 | -0.020 fraction of one | Standard Deviation 0.0239 |
| Part A: SAGE-217 | Change From Baseline in Hematocrit - Part A | Change from Baseline at Follow-up Day 28 | -0.017 fraction of one | Standard Deviation 0.0256 |
Primary
Change From Baseline in Hemoglobin - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Hemoglobin - Part A | Baseline | 136.7 grams per liter (g/L) | Standard Deviation 11.28 |
| Part A: SAGE-217 | Change From Baseline in Hemoglobin - Part A | Change from Baseline at Day 8 | 0.2 grams per liter (g/L) | Standard Deviation 4.3 |
| Part A: SAGE-217 | Change From Baseline in Hemoglobin - Part A | Change from Baseline at Day 15/ET | -2.4 grams per liter (g/L) | Standard Deviation 5.25 |
| Part A: SAGE-217 | Change From Baseline in Hemoglobin - Part A | Change from Baseline at Follow-up Day 21 | -5.7 grams per liter (g/L) | Standard Deviation 5.79 |
| Part A: SAGE-217 | Change From Baseline in Hemoglobin - Part A | Change from Baseline at Follow-up Day 28 | -4.8 grams per liter (g/L) | Standard Deviation 6.21 |
Primary
Change From Baseline in Leukocytes - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Leukocytes - Part A | Baseline | 7.16 10^9 cells/L | Standard Deviation 2.098 |
| Part A: SAGE-217 | Change From Baseline in Leukocytes - Part A | Change from Baseline at Day 8 | -0.82 10^9 cells/L | Standard Deviation 1.446 |
| Part A: SAGE-217 | Change From Baseline in Leukocytes - Part A | Change from Baseline at Day 15/ET | -0.91 10^9 cells/L | Standard Deviation 1.388 |
| Part A: SAGE-217 | Change From Baseline in Leukocytes - Part A | Change from Baseline at Follow-up Day 21 | -0.75 10^9 cells/L | Standard Deviation 1.331 |
| Part A: SAGE-217 | Change From Baseline in Leukocytes - Part A | Change from Baseline at Follow-up Day 28 | -0.49 10^9 cells/L | Standard Deviation 1.387 |
Primary
Change From Baseline in Lymphocytes - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Lymphocytes - Part A | Baseline | 2.356 10^9 cells/L | Standard Deviation 0.4184 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes - Part A | Change from Baseline at Day 8 | -0.302 10^9 cells/L | Standard Deviation 0.3742 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes - Part A | Change from Baseline at Day 15/ET | -0.339 10^9 cells/L | Standard Deviation 0.433 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes - Part A | Change from Baseline at Follow-up Day 21 | -0.260 10^9 cells/L | Standard Deviation 0.455 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes - Part A | Change from Baseline at Follow-up Day 28 | -0.204 10^9 cells/L | Standard Deviation 0.3183 |
Primary
Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part A | Baseline | 34.89 percentage | Standard Deviation 9.321 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part A | Change from Baseline at Day 8 | -1.75 percentage | Standard Deviation 4.741 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part A | Change from Baseline at Day 15/ET | -1.25 percentage | Standard Deviation 7.573 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part A | Change from Baseline at Follow-up Day 21 | -1.11 percentage | Standard Deviation 5.716 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part A | Change from Baseline at Follow-up Day 28 | -0.62 percentage | Standard Deviation 7.047 |
Primary
Change From Baseline in Monocytes - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Monocytes - Part A | Baseline | 0.485 10^9 cells/L | Standard Deviation 0.1785 |
| Part A: SAGE-217 | Change From Baseline in Monocytes - Part A | Change from Baseline at Day 8 | -0.042 10^9 cells/L | Standard Deviation 0.1673 |
| Part A: SAGE-217 | Change From Baseline in Monocytes - Part A | Change from Baseline at Day 15/ET | -0.074 10^9 cells/L | Standard Deviation 0.1373 |
| Part A: SAGE-217 | Change From Baseline in Monocytes - Part A | Change from Baseline at Follow-up Day 21 | -0.090 10^9 cells/L | Standard Deviation 0.1513 |
| Part A: SAGE-217 | Change From Baseline in Monocytes - Part A | Change from Baseline at Follow-up Day 28 | -0.103 10^9 cells/L | Standard Deviation 0.1369 |
Primary
Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part A | Baseline | 6.72 percentage | Standard Deviation 1.263 |
| Part A: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part A | Change from Baseline at Day 8 | 0.35 percentage | Standard Deviation 1.805 |
| Part A: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part A | Change from Baseline at Day 15/ET | -0.03 percentage | Standard Deviation 1.625 |
| Part A: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part A | Change from Baseline at Follow-up Day 21 | -0.67 percentage | Standard Deviation 2.364 |
| Part A: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part A | Change from Baseline at Follow-up Day 28 | -0.82 percentage | Standard Deviation 2.403 |
Primary
Change From Baseline in Neutrophils - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Neutrophils - Part A | Baseline | 4.126 10^9 cells/L | Standard Deviation 1.7922 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils - Part A | Change from Baseline at Day 8 | -0.485 10^9 cells/L | Standard Deviation 1.069 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils - Part A | Change from Baseline at Day 15/ET | -0.528 10^9 cells/L | Standard Deviation 1.1266 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils - Part A | Change from Baseline at Follow-up Day 21 | -0.411 10^9 cells/L | Standard Deviation 1.1296 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils - Part A | Change from Baseline at Follow-up Day 28 | -0.190 10^9 cells/L | Standard Deviation 1.2929 |
Primary
Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part A | Baseline | 55.63 percentage | Standard Deviation 8.925 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part A | Change from Baseline at Day 8 | 0.76 percentage | Standard Deviation 5.123 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part A | Change from Baseline at Day 15/ET | 0.16 percentage | Standard Deviation 8.428 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part A | Change from Baseline at Follow-up Day 21 | 1.23 percentage | Standard Deviation 7.037 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part A | Change from Baseline at Follow-up Day 28 | 1.06 percentage | Standard Deviation 8.908 |
Primary
Change From Baseline in pH - Part A
Urinalysis measures included pH and specific gravity. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in pH - Part A | Baseline | 6.46 pH | Standard Deviation 0.803 |
| Part A: SAGE-217 | Change From Baseline in pH - Part A | Change from Baseline at Day 8 | -0.15 pH | Standard Deviation 1.049 |
| Part A: SAGE-217 | Change From Baseline in pH - Part A | Change from Baseline at Day 15/ET | -0.35 pH | Standard Deviation 0.826 |
| Part A: SAGE-217 | Change From Baseline in pH - Part A | Change from Baseline at Follow-up Day 21 | -0.31 pH | Standard Deviation 1.407 |
| Part A: SAGE-217 | Change From Baseline in pH - Part A | Change from Baseline at Follow-up Day 28 | -0.19 pH | Standard Deviation 1.3 |
Primary
Change From Baseline in Platelets - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Platelets - Part A | Baseline | 265.5 10^9 cells/L | Standard Deviation 50.99 |
| Part A: SAGE-217 | Change From Baseline in Platelets - Part A | Change from Baseline at Day 8 | -13.4 10^9 cells/L | Standard Deviation 26.77 |
| Part A: SAGE-217 | Change From Baseline in Platelets - Part A | Change from Baseline at Day 15/ET | -7.8 10^9 cells/L | Standard Deviation 25 |
| Part A: SAGE-217 | Change From Baseline in Platelets - Part A | Change from Baseline at Follow-up Day 21 | 8.8 10^9 cells/L | Standard Deviation 19.68 |
| Part A: SAGE-217 | Change From Baseline in Platelets - Part A | Change from Baseline at Follow-up Day 28 | -9.9 10^9 cells/L | Standard Deviation 34.29 |
Primary
Change From Baseline in Potassium - Part A
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Potassium - Part A | Baseline | 4.25 mmol/L | Standard Deviation 0.273 |
| Part A: SAGE-217 | Change From Baseline in Potassium - Part A | Change from Baseline at Day 8 | 0.12 mmol/L | Standard Deviation 0.365 |
| Part A: SAGE-217 | Change From Baseline in Potassium - Part A | Change from Baseline at Day 15/ET | 0.02 mmol/L | Standard Deviation 0.349 |
| Part A: SAGE-217 | Change From Baseline in Potassium - Part A | Change from Baseline at Follow-up Day 21 | -0.04 mmol/L | Standard Deviation 0.423 |
| Part A: SAGE-217 | Change From Baseline in Potassium - Part A | Change from Baseline at Follow-up Day 28 | -0.10 mmol/L | Standard Deviation 0.416 |
Primary
Change From Baseline in PR Interval - Part A
ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study.
Time frame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in PR Interval - Part A | Baseline | 158.0 msec |
| Part A: SAGE-217 | Change From Baseline in PR Interval - Part A | Change from Baseline at Day 1 | 1.0 msec |
| Part A: SAGE-217 | Change From Baseline in PR Interval - Part A | Change from Baseline at Day 2 | -8.0 msec |
| Part A: SAGE-217 | Change From Baseline in PR Interval - Part A | Change from Baseline at Day 7 | 2.0 msec |
| Part A: SAGE-217 | Change From Baseline in PR Interval - Part A | Change from Baseline at Day 14 | 5.0 msec |
| Part A: SAGE-217 | Change From Baseline in PR Interval - Part A | Change from Baseline at Follow-up Day 21 | -3.5 msec |
Primary
Change From Baseline in Protein - Part A
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Protein - Part A | Baseline | 71.8 g/L | Standard Deviation 3.59 |
| Part A: SAGE-217 | Change From Baseline in Protein - Part A | Change from Baseline at Day 8 | -0.6 g/L | Standard Deviation 5.36 |
| Part A: SAGE-217 | Change From Baseline in Protein - Part A | Change from Baseline at Day 15/ET | -0.2 g/L | Standard Deviation 4.85 |
| Part A: SAGE-217 | Change From Baseline in Protein - Part A | Change from Baseline at Follow-up Day 21 | -2.5 g/L | Standard Deviation 4.33 |
| Part A: SAGE-217 | Change From Baseline in Protein - Part A | Change from Baseline at Follow-up Day 28 | -0.1 g/L | Standard Deviation 3.57 |
Primary
Change From Baseline in Prothrombin International Normalized Ratio (%) - Part A
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part A of the study. ET = Early Termination. The data for prothrombin international normalized ratio are presented as SI unit, percentage (%).
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part A | Baseline | 1.02 percentage | Standard Deviation 0.055 |
| Part A: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part A | Change from Baseline at Day 8 | 0.04 percentage | Standard Deviation 0.087 |
| Part A: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part A | Change from Baseline at Day 15/ET | -0.04 percentage | Standard Deviation 0.051 |
| Part A: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part A | Change from Baseline at Follow-up Day 21 | -0.01 percentage | Standard Deviation 0.049 |
| Part A: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part A | Change from Baseline at Follow-up Day 28 | -0.02 percentage | Standard Deviation 0.038 |
Primary
Change From Baseline in Prothrombin Time - Part A
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Prothrombin Time - Part A | Baseline | 10.50 seconds |
| Part A: SAGE-217 | Change From Baseline in Prothrombin Time - Part A | Change from Baseline at Day 8 | 0.10 seconds |
| Part A: SAGE-217 | Change From Baseline in Prothrombin Time - Part A | Change from Baseline at Day 15/ET | -0.40 seconds |
| Part A: SAGE-217 | Change From Baseline in Prothrombin Time - Part A | Change from Baseline at Follow-up Day 21 | -0.10 seconds |
| Part A: SAGE-217 | Change From Baseline in Prothrombin Time - Part A | Change from Baseline at Follow-up Day 28 | 0.00 seconds |
Primary
Change From Baseline in QRS Interval - Part A
ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study.
Time frame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in QRS Interval - Part A | Change from Baseline at Day 1 | 0.0 msec |
| Part A: SAGE-217 | Change From Baseline in QRS Interval - Part A | Change from Baseline at Day 2 | -2.0 msec |
| Part A: SAGE-217 | Change From Baseline in QRS Interval - Part A | Baseline | 94.0 msec |
| Part A: SAGE-217 | Change From Baseline in QRS Interval - Part A | Change from Baseline at Day 7 | -1.0 msec |
| Part A: SAGE-217 | Change From Baseline in QRS Interval - Part A | Change from Baseline at Day 14 | 4.0 msec |
| Part A: SAGE-217 | Change From Baseline in QRS Interval - Part A | Change from Baseline at Follow-up Day 21 | -0.5 msec |
Primary
Change From Baseline in QTcF Interval - Part A
ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study.
Time frame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in QTcF Interval - Part A | Baseline | 423.0 msec |
| Part A: SAGE-217 | Change From Baseline in QTcF Interval - Part A | Change from Baseline at Day 1 | 2.0 msec |
| Part A: SAGE-217 | Change From Baseline in QTcF Interval - Part A | Change from Baseline at Day 2 | -5.0 msec |
| Part A: SAGE-217 | Change From Baseline in QTcF Interval - Part A | Change from Baseline at Day 7 | -4.0 msec |
| Part A: SAGE-217 | Change From Baseline in QTcF Interval - Part A | Change from Baseline at Day 14 | -8.0 msec |
| Part A: SAGE-217 | Change From Baseline in QTcF Interval - Part A | Change from Baseline at Follow-up Day 21 | -7.0 msec |
Primary
Change From Baseline in QT Interval - Part A
Electrocardiogram (ECG) measures included QT interval, QTc based on Fridericia formula (QTcF interval), ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study.
Time frame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in QT Interval - Part A | Baseline | 401.0 milliseconds (msec) |
| Part A: SAGE-217 | Change From Baseline in QT Interval - Part A | Change from Baseline at Day 1 | -8.0 milliseconds (msec) |
| Part A: SAGE-217 | Change From Baseline in QT Interval - Part A | Change from Baseline at Day 2 | -12.0 milliseconds (msec) |
| Part A: SAGE-217 | Change From Baseline in QT Interval - Part A | Change from Baseline at Day 7 | -22.0 milliseconds (msec) |
| Part A: SAGE-217 | Change From Baseline in QT Interval - Part A | Change from Baseline at Day 14 | -16.0 milliseconds (msec) |
| Part A: SAGE-217 | Change From Baseline in QT Interval - Part A | Change from Baseline at Follow-up Day 21 | -17.5 milliseconds (msec) |
Primary
Change From Baseline in Reticulocytes - Part A
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes and leukocytes. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Reticulocytes - Part A | Baseline | 51.926 10^9 cells/L | Standard Deviation 21.8233 |
| Part A: SAGE-217 | Change From Baseline in Reticulocytes - Part A | Change from Baseline at Day 8 | -3.694 10^9 cells/L | Standard Deviation 22.4664 |
| Part A: SAGE-217 | Change From Baseline in Reticulocytes - Part A | Change from Baseline at Day 15/ET | -6.163 10^9 cells/L | Standard Deviation 24.9724 |
| Part A: SAGE-217 | Change From Baseline in Reticulocytes - Part A | Change from Baseline at Follow-up Day 21 | 6.174 10^9 cells/L | Standard Deviation 27.1013 |
| Part A: SAGE-217 | Change From Baseline in Reticulocytes - Part A | Change from Baseline at Follow-up Day 28 | 13.012 10^9 cells/L | Standard Deviation 24.3634 |
Primary
Change From Baseline in RR Interval - Part A
ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part A of the study.
Time frame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in RR Interval - Part A | Baseline | 952.0 msec |
| Part A: SAGE-217 | Change From Baseline in RR Interval - Part A | Change from Baseline at Day 1 | -65.0 msec |
| Part A: SAGE-217 | Change From Baseline in RR Interval - Part A | Change from Baseline at Day 2 | -45.0 msec |
| Part A: SAGE-217 | Change From Baseline in RR Interval - Part A | Change from Baseline at Day 7 | -88.0 msec |
| Part A: SAGE-217 | Change From Baseline in RR Interval - Part A | Change from Baseline at Day 14 | -107.0 msec |
| Part A: SAGE-217 | Change From Baseline in RR Interval - Part A | Change from Baseline at Follow-up Day 21 | -97.0 msec |
Primary
Change From Baseline in Sodium - Part A
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Sodium - Part A | Baseline | 138.5 mmol/L | Standard Deviation 2.18 |
| Part A: SAGE-217 | Change From Baseline in Sodium - Part A | Change from Baseline at Day 8 | -0.2 mmol/L | Standard Deviation 2.05 |
| Part A: SAGE-217 | Change From Baseline in Sodium - Part A | Change from Baseline at Day 15/ET | -0.1 mmol/L | Standard Deviation 2.43 |
| Part A: SAGE-217 | Change From Baseline in Sodium - Part A | Change from Baseline at Follow-up Day 21 | 0.5 mmol/L | Standard Deviation 2.76 |
| Part A: SAGE-217 | Change From Baseline in Sodium - Part A | Change from Baseline at Follow-up Day 28 | 0.5 mmol/L | Standard Deviation 2.9 |
Primary
Change From Baseline in Specific Gravity - Part A
Urinalysis measures included pH and specific gravity. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Specific Gravity - Part A | Baseline | 1.014 ratio | Standard Deviation 0.0083 |
| Part A: SAGE-217 | Change From Baseline in Specific Gravity - Part A | Change from Baseline at Day 8 | 0.001 ratio | Standard Deviation 0.0075 |
| Part A: SAGE-217 | Change From Baseline in Specific Gravity - Part A | Change from Baseline at Day 15/ET | 0.000 ratio | Standard Deviation 0.0066 |
| Part A: SAGE-217 | Change From Baseline in Specific Gravity - Part A | Change from Baseline at Follow-up Day 21 | 0.003 ratio | Standard Deviation 0.0084 |
| Part A: SAGE-217 | Change From Baseline in Specific Gravity - Part A | Change from Baseline at Follow-up Day 28 | -0.001 ratio | Standard Deviation 0.0076 |
Primary
Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 15 - Part A
The SSS was participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of one to seven, where the lowest score of 'one' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of 'seven' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. A negative change from baseline indicated less sleepiness. A positive change from baseline indicated more sleepiness. The analysis was performed in participants included in Part A of the study.
Time frame: Baseline, Day 15
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 15 - Part A | Baseline | 2.3 score on a scale | Standard Deviation 1.6 |
| Part A: SAGE-217 | Change From Baseline in Stanford Sleepiness Scale (SSS) Score at Day 15 - Part A | Change from Baseline at Day 15 | -0.6 score on a scale | Standard Deviation 1.5 |
Primary
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 - Part B
The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study.
Time frame: Baseline, Day 15
Population: The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 - Part B | -10.3 score on a scale | Standard Error 1.33 |
| Part B: SAGE-217 | Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 - Part B | -17.4 score on a scale | Standard Error 1.31 |
p-value: <0.000195% CI: [-10.2, -3.9]Mixed Effect Model for Repeated Measures
Primary
Change From Baseline in Urea Nitrogen - Part A
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, chloride, carbon dioxide, creatinine, potassium, protein, sodium, and urea nitrogen. The analysis was performed in participants included in Part A of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Day 21, follow-up Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Urea Nitrogen - Part A | Baseline | 4.888 mmol/L | Standard Deviation 1.4234 |
| Part A: SAGE-217 | Change From Baseline in Urea Nitrogen - Part A | Change from Baseline at Day 8 | -0.275 mmol/L | Standard Deviation 1.6435 |
| Part A: SAGE-217 | Change From Baseline in Urea Nitrogen - Part A | Change from Baseline at Day 15/ET | -0.412 mmol/L | Standard Deviation 1.4563 |
| Part A: SAGE-217 | Change From Baseline in Urea Nitrogen - Part A | Change from Baseline at Follow-up Day 21 | -0.357 mmol/L | Standard Deviation 0.9885 |
| Part A: SAGE-217 | Change From Baseline in Urea Nitrogen - Part A | Change from Baseline at Follow-up Day 28 | -0.741 mmol/L | Standard Deviation 1.3552 |
Primary
Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Item - Part A
The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation (SI) and behavior and a postbaseline evaluation that focused on suicidality since the last study visit. The C-SSRS included yes or no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with specific plan. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 up to Day 28
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: SAGE-217 | Percentage of Participants With a Response of 'Yes' to Any Columbia Suicide Severity Rating Scale (C-SSRS) Suicidal Ideation Item - Part A | 0 percentage of participants |
Primary
Percentage of Participants With TEAEs, Graded by Severity - Part A
Severity was assessed according to the following scale: mild (awareness of sign or symptom, but easily tolerated); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with inability to perform normal activities). The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 up to Day 21
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: SAGE-217 | Percentage of Participants With TEAEs, Graded by Severity - Part A | Severe | 0 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With TEAEs, Graded by Severity - Part A | Mild | 69.2 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With TEAEs, Graded by Severity - Part A | Moderate | 23.1 percentage of participants |
Primary
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part A
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was defined as an adverse event with onset after the start of study drug, or any worsening of a pre-existing medical condition/adverse event with onset after the start of study drug and until 7 days after the last dose. The analysis was performed in participants included in Part A of the study.
Time frame: Day 1 up to Day 21
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: SAGE-217 | Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) - Part A | 92.3 percentage of participants |
Secondary
Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B
The HAM-D comprised individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (GI and general), genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study.
Time frame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21, 28, 35 and 42
Population: The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. Number analyzed: Number of participants in efficacy set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: Baseline | 0.8 score on a scale | Standard Deviation 0.89 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 28 | -1.0 score on a scale | Standard Deviation 1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 2 | -0.1 score on a scale | Standard Deviation 0.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 28 | -0.6 score on a scale | Standard Deviation 0.97 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 3 | -0.2 score on a scale | Standard Deviation 0.67 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 35 | -0.9 score on a scale | Standard Deviation 1.13 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 4 | -0.3 score on a scale | Standard Deviation 0.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 21 | -1.1 score on a scale | Standard Deviation 1.04 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 5 | -0.3 score on a scale | Standard Deviation 0.82 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 42 | -0.9 score on a scale | Standard Deviation 1.08 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 6 | -0.3 score on a scale | Standard Deviation 0.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 15 | -0.7 score on a scale | Standard Deviation 0.91 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 7 | -0.4 score on a scale | Standard Deviation 0.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: Baseline | 1.4 score on a scale | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 8 | -0.4 score on a scale | Standard Deviation 0.93 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 28 | -1.0 score on a scale | Standard Deviation 1.03 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 15 | -0.4 score on a scale | Standard Deviation 0.96 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 2 | -0.3 score on a scale | Standard Deviation 0.61 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 21 | -0.4 score on a scale | Standard Deviation 0.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 2 | -0.1 score on a scale | Standard Deviation 0.55 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 28 | -0.4 score on a scale | Standard Deviation 0.75 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 3 | -0.4 score on a scale | Standard Deviation 0.75 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 35 | -0.5 score on a scale | Standard Deviation 0.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 35 | -1.2 score on a scale | Standard Deviation 1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 42 | -0.5 score on a scale | Standard Deviation 0.79 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 4 | -0.5 score on a scale | Standard Deviation 0.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: Baseline | 3.1 score on a scale | Standard Deviation 0.56 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 21 | -0.8 score on a scale | Standard Deviation 0.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 2 | -0.3 score on a scale | Standard Deviation 0.54 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 5 | -0.4 score on a scale | Standard Deviation 0.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 3 | -0.5 score on a scale | Standard Deviation 0.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 42 | -1.3 score on a scale | Standard Deviation 0.95 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 4 | -0.7 score on a scale | Standard Deviation 0.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 6 | -0.4 score on a scale | Standard Deviation 0.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 5 | -1.0 score on a scale | Standard Deviation 0.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 8 | -0.6 score on a scale | Standard Deviation 0.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 6 | -1.0 score on a scale | Standard Deviation 0.99 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 7 | -0.4 score on a scale | Standard Deviation 0.91 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 7 | -1.1 score on a scale | Standard Deviation 1.14 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: Baseline | 0.3 score on a scale | Standard Deviation 0.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 8 | -1.4 score on a scale | Standard Deviation 1.25 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 8 | -0.6 score on a scale | Standard Deviation 0.99 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 15 | -1.3 score on a scale | Standard Deviation 1.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 28 | -0.8 score on a scale | Standard Deviation 0.96 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 21 | -1.3 score on a scale | Standard Deviation 1.34 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 15 | -0.6 score on a scale | Standard Deviation 0.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 28 | -1.3 score on a scale | Standard Deviation 1.31 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 2 | -0.2 score on a scale | Standard Deviation 0.46 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 35 | -1.3 score on a scale | Standard Deviation 1.31 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 21 | -0.7 score on a scale | Standard Deviation 0.92 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 42 | -1.4 score on a scale | Standard Deviation 1.29 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 3 | -0.3 score on a scale | Standard Deviation 0.47 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: Baseline | 3.1 score on a scale | Standard Deviation 0.42 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 28 | -0.7 score on a scale | Standard Deviation 0.9 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 2 | -0.3 score on a scale | Standard Deviation 0.56 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 3 | -0.2 score on a scale | Standard Deviation 0.46 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 3 | -0.5 score on a scale | Standard Deviation 0.59 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 35 | -0.8 score on a scale | Standard Deviation 0.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 4 | -0.9 score on a scale | Standard Deviation 0.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 35 | -0.9 score on a scale | Standard Deviation 0.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 5 | -1.0 score on a scale | Standard Deviation 0.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 42 | -0.6 score on a scale | Standard Deviation 1.02 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 6 | -1.2 score on a scale | Standard Deviation 0.99 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 4 | -0.2 score on a scale | Standard Deviation 0.45 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 7 | -1.1 score on a scale | Standard Deviation 1.05 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: Baseline | 1.1 score on a scale | Standard Deviation 0.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 8 | -1.4 score on a scale | Standard Deviation 1.15 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 35 | -0.7 score on a scale | Standard Deviation 0.97 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 15 | -1.5 score on a scale | Standard Deviation 1.09 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 2 | -0.2 score on a scale | Standard Deviation 0.76 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 21 | -1.5 score on a scale | Standard Deviation 1.22 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 5 | -0.2 score on a scale | Standard Deviation 0.45 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 28 | -1.6 score on a scale | Standard Deviation 1.27 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 3 | -0.3 score on a scale | Standard Deviation 0.74 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 35 | -1.7 score on a scale | Standard Deviation 1.26 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 42 | -0.8 score on a scale | Standard Deviation 0.92 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 42 | -1.8 score on a scale | Standard Deviation 1.29 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 4 | -0.5 score on a scale | Standard Deviation 0.83 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: Baseline | 1.7 score on a scale | Standard Deviation 0.71 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 6 | -0.2 score on a scale | Standard Deviation 0.48 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 2 | 0.0 score on a scale | Standard Deviation 0.82 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 5 | -0.5 score on a scale | Standard Deviation 0.9 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 3 | -0.2 score on a scale | Standard Deviation 0.92 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 4 | -0.5 score on a scale | Standard Deviation 0.74 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 4 | -0.3 score on a scale | Standard Deviation 0.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 6 | -0.5 score on a scale | Standard Deviation 1.02 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 5 | -0.3 score on a scale | Standard Deviation 0.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 7 | -0.2 score on a scale | Standard Deviation 0.48 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 6 | -0.5 score on a scale | Standard Deviation 1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 7 | -0.5 score on a scale | Standard Deviation 1.03 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 7 | -0.3 score on a scale | Standard Deviation 0.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: Baseline | 2.1 score on a scale | Standard Deviation 0.7 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 8 | -0.4 score on a scale | Standard Deviation 1.01 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 8 | -0.5 score on a scale | Standard Deviation 1.02 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 15 | -0.2 score on a scale | Standard Deviation 0.96 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 8 | -0.2 score on a scale | Standard Deviation 0.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 21 | -0.3 score on a scale | Standard Deviation 1.14 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 15 | -0.5 score on a scale | Standard Deviation 0.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 28 | -0.5 score on a scale | Standard Deviation 1.17 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 21 | -0.7 score on a scale | Standard Deviation 0.93 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 35 | -0.5 score on a scale | Standard Deviation 1.13 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 21 | -0.5 score on a scale | Standard Deviation 0.73 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 42 | -0.7 score on a scale | Standard Deviation 1.13 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 15 | -0.2 score on a scale | Standard Deviation 0.52 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: Baseline | 1.8 score on a scale | Standard Deviation 0.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 28 | -0.5 score on a scale | Standard Deviation 0.91 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 2 | -0.4 score on a scale | Standard Deviation 0.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 2 | -0.3 score on a scale | Standard Deviation 0.69 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 3 | -0.5 score on a scale | Standard Deviation 0.79 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 35 | -0.6 score on a scale | Standard Deviation 0.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 4 | -0.6 score on a scale | Standard Deviation 0.95 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 21 | -0.2 score on a scale | Standard Deviation 0.54 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 5 | -0.6 score on a scale | Standard Deviation 0.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 42 | -0.6 score on a scale | Standard Deviation 0.96 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 6 | -0.8 score on a scale | Standard Deviation 1.05 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 5 | -0.5 score on a scale | Standard Deviation 0.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 7 | -0.7 score on a scale | Standard Deviation 0.99 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: Baseline | 0.1 score on a scale | Standard Deviation 0.25 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 8 | -0.9 score on a scale | Standard Deviation 1.01 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 28 | -0.2 score on a scale | Standard Deviation 0.52 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 15 | -0.6 score on a scale | Standard Deviation 0.99 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 2 | 0.0 score on a scale | Standard Deviation 0.15 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 21 | -0.8 score on a scale | Standard Deviation 0.9 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 3 | -0.5 score on a scale | Standard Deviation 0.73 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 28 | -0.8 score on a scale | Standard Deviation 0.98 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 3 | 0.0 score on a scale | Standard Deviation 0.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 35 | -0.9 score on a scale | Standard Deviation 1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 35 | -0.2 score on a scale | Standard Deviation 0.52 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 42 | -0.8 score on a scale | Standard Deviation 0.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 4 | 0.0 score on a scale | Standard Deviation 0.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: Baseline | 1.6 score on a scale | Standard Deviation 0.7 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 42 | -0.6 score on a scale | Standard Deviation 0.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 2 | -0.5 score on a scale | Standard Deviation 0.95 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 5 | 0.0 score on a scale | Standard Deviation 0.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 3 | -0.6 score on a scale | Standard Deviation 1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 42 | -0.2 score on a scale | Standard Deviation 0.52 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 4 | -0.7 score on a scale | Standard Deviation 1.09 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 6 | 0.0 score on a scale | Standard Deviation 0.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 5 | -0.8 score on a scale | Standard Deviation 1.06 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 4 | -0.6 score on a scale | Standard Deviation 0.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 6 | -0.8 score on a scale | Standard Deviation 1.06 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 7 | 0.0 score on a scale | Standard Deviation 0.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 7 | -0.9 score on a scale | Standard Deviation 1.1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: Baseline | 2.3 score on a scale | Standard Deviation 0.67 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 8 | -0.9 score on a scale | Standard Deviation 1.05 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 8 | 0.0 score on a scale | Standard Deviation 0.22 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 15 | -0.7 score on a scale | Standard Deviation 1.04 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 6 | -0.6 score on a scale | Standard Deviation 0.7 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 21 | -0.8 score on a scale | Standard Deviation 1.05 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 15 | 0.0 score on a scale | Standard Deviation 0.22 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 28 | -0.8 score on a scale | Standard Deviation 1.14 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 2 | -0.3 score on a scale | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 35 | -1.0 score on a scale | Standard Deviation 1.11 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 21 | -0.1 score on a scale | Standard Deviation 0.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 42 | -0.9 score on a scale | Standard Deviation 1.09 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 5 | -0.7 score on a scale | Standard Deviation 0.76 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: Baseline | 1.7 score on a scale | Standard Deviation 0.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 28 | -0.1 score on a scale | Standard Deviation 0.22 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 2 | -0.1 score on a scale | Standard Deviation 0.5 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 3 | -0.5 score on a scale | Standard Deviation 0.66 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 3 | -0.1 score on a scale | Standard Deviation 0.42 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 35 | -0.1 score on a scale | Standard Deviation 0.22 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 4 | -0.2 score on a scale | Standard Deviation 0.57 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 15 | -0.7 score on a scale | Standard Deviation 0.93 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 5 | -0.2 score on a scale | Standard Deviation 0.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 42 | -0.1 score on a scale | Standard Deviation 0.22 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 6 | -0.3 score on a scale | Standard Deviation 0.61 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 4 | -0.7 score on a scale | Standard Deviation 1.05 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 7 | -0.3 score on a scale | Standard Deviation 0.58 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: Baseline | 0.8 score on a scale | Standard Deviation 0.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 8 | -0.4 score on a scale | Standard Deviation 0.67 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 6 | -0.8 score on a scale | Standard Deviation 0.97 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 15 | -0.6 score on a scale | Standard Deviation 0.79 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 2 | -0.2 score on a scale | Standard Deviation 0.73 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 21 | -0.6 score on a scale | Standard Deviation 0.89 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 5 | -0.8 score on a scale | Standard Deviation 1.05 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 28 | -0.6 score on a scale | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 3 | -0.2 score on a scale | Standard Deviation 0.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 35 | -0.7 score on a scale | Standard Deviation 0.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 7 | -0.6 score on a scale | Standard Deviation 0.72 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 42 | -0.6 score on a scale | Standard Deviation 0.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 4 | -0.2 score on a scale | Standard Deviation 0.97 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: Baseline | 1.3 score on a scale | Standard Deviation 0.79 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 6 | -0.8 score on a scale | Standard Deviation 0.91 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 2 | -0.1 score on a scale | Standard Deviation 0.69 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 5 | -0.4 score on a scale | Standard Deviation 0.76 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 3 | -0.2 score on a scale | Standard Deviation 0.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 7 | -0.9 score on a scale | Standard Deviation 0.99 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 4 | -0.4 score on a scale | Standard Deviation 0.82 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 6 | -0.3 score on a scale | Standard Deviation 0.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 5 | -0.5 score on a scale | Standard Deviation 0.98 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 7 | -0.9 score on a scale | Standard Deviation 1.01 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 6 | -0.5 score on a scale | Standard Deviation 0.95 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 7 | -0.3 score on a scale | Standard Deviation 0.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 7 | -0.4 score on a scale | Standard Deviation 1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: Baseline | 1.7 score on a scale | Standard Deviation 0.5 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 8 | -0.5 score on a scale | Standard Deviation 0.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 8 | -0.5 score on a scale | Standard Deviation 0.92 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 15 | -0.4 score on a scale | Standard Deviation 1.01 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 8 | -1.1 score on a scale | Standard Deviation 0.97 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 21 | -0.6 score on a scale | Standard Deviation 0.95 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 15 | -0.4 score on a scale | Standard Deviation 0.99 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 28 | -0.6 score on a scale | Standard Deviation 0.91 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 8 | -1.2 score on a scale | Standard Deviation 0.91 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 35 | -0.7 score on a scale | Standard Deviation 0.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 21 | -0.4 score on a scale | Standard Deviation 0.79 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 42 | -0.7 score on a scale | Standard Deviation 0.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 15 | -0.9 score on a scale | Standard Deviation 0.93 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: Baseline | 0.9 score on a scale | Standard Deviation 0.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 28 | -0.6 score on a scale | Standard Deviation 1.04 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 2 | -0.5 score on a scale | Standard Deviation 0.73 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 8 | -0.6 score on a scale | Standard Deviation 0.79 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 3 | -0.5 score on a scale | Standard Deviation 0.9 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 35 | -0.6 score on a scale | Standard Deviation 0.96 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 4 | -0.5 score on a scale | Standard Deviation 0.91 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 21 | -1.0 score on a scale | Standard Deviation 0.9 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 5 | -0.6 score on a scale | Standard Deviation 0.97 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 42 | -0.6 score on a scale | Standard Deviation 0.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 6 | -0.6 score on a scale | Standard Deviation 0.9 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 15 | -1.0 score on a scale | Standard Deviation 1.15 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 7 | -0.7 score on a scale | Standard Deviation 0.87 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 2 | -0.5 score on a scale | Standard Deviation 0.89 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 8 | -0.8 score on a scale | Standard Deviation 0.91 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 15 | -0.8 score on a scale | Standard Deviation 0.88 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 21 | -0.9 score on a scale | Standard Deviation 0.88 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 28 | -1.0 score on a scale | Standard Deviation 0.88 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 35 | -0.9 score on a scale | Standard Deviation 0.9 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 42 | -0.9 score on a scale | Standard Deviation 0.95 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: Baseline | 1.7 score on a scale | Standard Deviation 0.46 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 2 | -0.3 score on a scale | Standard Deviation 0.6 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 3 | -0.4 score on a scale | Standard Deviation 0.66 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 4 | -0.5 score on a scale | Standard Deviation 0.73 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 5 | -0.5 score on a scale | Standard Deviation 0.89 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 6 | -0.7 score on a scale | Standard Deviation 0.89 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 7 | -0.9 score on a scale | Standard Deviation 0.76 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 8 | -0.8 score on a scale | Standard Deviation 0.86 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 15 | -1.1 score on a scale | Standard Deviation 0.78 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 21 | -1.0 score on a scale | Standard Deviation 0.9 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 28 | -0.9 score on a scale | Standard Deviation 0.87 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 35 | -1.0 score on a scale | Standard Deviation 0.89 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms General: CFB at Day 42 | -0.9 score on a scale | Standard Deviation 0.89 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: Baseline | 1.9 score on a scale | Standard Deviation 0.83 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 2 | -0.4 score on a scale | Standard Deviation 0.68 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 3 | -0.5 score on a scale | Standard Deviation 0.82 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 4 | -0.7 score on a scale | Standard Deviation 0.84 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 5 | -1.0 score on a scale | Standard Deviation 0.93 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 6 | -1.2 score on a scale | Standard Deviation 0.96 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 7 | -1.2 score on a scale | Standard Deviation 1.04 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 8 | -1.2 score on a scale | Standard Deviation 1.12 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 15 | -1.4 score on a scale | Standard Deviation 1.01 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 21 | -1.2 score on a scale | Standard Deviation 1.12 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 28 | -1.3 score on a scale | Standard Deviation 1.05 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 35 | -1.1 score on a scale | Standard Deviation 1.14 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Feelings of Guilt: CFB at Day 42 | -1.2 score on a scale | Standard Deviation 1.09 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: Baseline | 0.1 score on a scale | Standard Deviation 0.29 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 2 | 0.0 score on a scale | Standard Deviation 0.15 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 3 | 0.0 score on a scale | Standard Deviation 0.15 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 4 | 0.0 score on a scale | Standard Deviation 0.21 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 5 | 0.0 score on a scale | Standard Deviation 0.26 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 6 | 0.0 score on a scale | Standard Deviation 0.21 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 7 | -0.1 score on a scale | Standard Deviation 0.25 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 8 | -0.1 score on a scale | Standard Deviation 0.29 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 15 | -0.1 score on a scale | Standard Deviation 0.3 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 21 | -0.1 score on a scale | Standard Deviation 0.3 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 28 | -0.1 score on a scale | Standard Deviation 0.3 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 35 | -0.1 score on a scale | Standard Deviation 0.26 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Suicide: CFB at Day 42 | -0.1 score on a scale | Standard Deviation 0.3 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: Baseline | 2.1 score on a scale | Standard Deviation 0.49 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 2 | -0.4 score on a scale | Standard Deviation 0.75 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 3 | -0.8 score on a scale | Standard Deviation 0.94 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 4 | -1.0 score on a scale | Standard Deviation 1.16 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 5 | -1.1 score on a scale | Standard Deviation 0.98 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 6 | -1.2 score on a scale | Standard Deviation 1.13 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 7 | -1.1 score on a scale | Standard Deviation 1.25 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 8 | -1.2 score on a scale | Standard Deviation 1.01 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 15 | -1.5 score on a scale | Standard Deviation 0.86 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 21 | -1.4 score on a scale | Standard Deviation 0.97 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 28 | -1.2 score on a scale | Standard Deviation 0.92 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 35 | -1.1 score on a scale | Standard Deviation 1.04 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Psychic: CFB at Day 42 | -1.2 score on a scale | Standard Deviation 0.83 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: Baseline | 1.4 score on a scale | Standard Deviation 0.75 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 2 | -0.4 score on a scale | Standard Deviation 0.81 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 3 | -0.6 score on a scale | Standard Deviation 0.84 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 4 | -0.5 score on a scale | Standard Deviation 0.84 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 5 | -0.6 score on a scale | Standard Deviation 0.81 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 6 | -0.6 score on a scale | Standard Deviation 0.69 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 7 | -0.5 score on a scale | Standard Deviation 0.87 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 8 | -0.7 score on a scale | Standard Deviation 0.87 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 15 | -0.8 score on a scale | Standard Deviation 0.83 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 21 | -0.8 score on a scale | Standard Deviation 0.87 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 28 | -0.7 score on a scale | Standard Deviation 0.94 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 35 | -0.8 score on a scale | Standard Deviation 0.86 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Anxiety Somatic: CFB at Day 42 | -0.8 score on a scale | Standard Deviation 0.85 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: Baseline | 1.0 score on a scale | Standard Deviation 0.83 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 2 | -0.2 score on a scale | Standard Deviation 0.67 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 3 | -0.3 score on a scale | Standard Deviation 0.84 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 4 | -0.5 score on a scale | Standard Deviation 0.82 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 5 | -0.6 score on a scale | Standard Deviation 0.78 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 6 | -0.6 score on a scale | Standard Deviation 0.8 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 7 | -0.5 score on a scale | Standard Deviation 0.84 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 8 | -0.6 score on a scale | Standard Deviation 0.87 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 15 | -0.7 score on a scale | Standard Deviation 0.91 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 21 | -0.7 score on a scale | Standard Deviation 0.81 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 28 | -0.7 score on a scale | Standard Deviation 0.92 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 35 | -0.7 score on a scale | Standard Deviation 0.94 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Hypochondriasis: CFB at Day 42 | -0.7 score on a scale | Standard Deviation 0.92 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: Baseline | 0.1 score on a scale | Standard Deviation 0.25 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 2 | 0.0 score on a scale | Standard Deviation 0.21 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 3 | 0.0 score on a scale | Standard Deviation 0.26 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 4 | 0.0 score on a scale | Standard Deviation 0.26 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 5 | 0.0 score on a scale | Standard Deviation 0.26 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 6 | 0.0 score on a scale | Standard Deviation 0.26 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 7 | 0.0 score on a scale | Standard Deviation 0.26 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 8 | 0.0 score on a scale | Standard Deviation 0.26 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 15 | 0.0 score on a scale | Standard Deviation 0.22 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 21 | 0.0 score on a scale | Standard Deviation 0.22 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 28 | 0.0 score on a scale | Standard Deviation 0.15 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 35 | 0.0 score on a scale | Standard Deviation 0.16 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insight: CFB at Day 42 | 0.0 score on a scale | Standard Deviation 0.22 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: Baseline | 0.5 score on a scale | Standard Deviation 0.63 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 2 | 0.0 score on a scale | Standard Deviation 0.52 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 3 | -0.2 score on a scale | Standard Deviation 0.53 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 4 | -0.2 score on a scale | Standard Deviation 0.53 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 5 | -0.2 score on a scale | Standard Deviation 0.61 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 6 | -0.3 score on a scale | Standard Deviation 0.6 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 7 | -0.3 score on a scale | Standard Deviation 0.6 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 8 | -0.3 score on a scale | Standard Deviation 0.64 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 15 | -0.4 score on a scale | Standard Deviation 0.66 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 21 | -0.3 score on a scale | Standard Deviation 0.65 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 28 | -0.4 score on a scale | Standard Deviation 0.59 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 35 | -0.4 score on a scale | Standard Deviation 0.63 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Agitation: CFB at Day 42 | -0.3 score on a scale | Standard Deviation 0.68 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: Baseline | 1.2 score on a scale | Standard Deviation 0.97 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 2 | -0.2 score on a scale | Standard Deviation 0.83 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 3 | -0.5 score on a scale | Standard Deviation 0.87 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 4 | -0.7 score on a scale | Standard Deviation 0.95 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 5 | -0.8 score on a scale | Standard Deviation 0.96 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 6 | -0.9 score on a scale | Standard Deviation 0.99 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 7 | -0.8 score on a scale | Standard Deviation 0.9 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 8 | -0.8 score on a scale | Standard Deviation 0.93 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 15 | -1.0 score on a scale | Standard Deviation 0.91 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 21 | -1.1 score on a scale | Standard Deviation 0.93 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 28 | -1.0 score on a scale | Standard Deviation 1.02 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 35 | -1.0 score on a scale | Standard Deviation 0.94 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Retardation: CFB at Day 42 | -0.9 score on a scale | Standard Deviation 0.99 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: Baseline | 3.1 score on a scale | Standard Deviation 0.32 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 2 | -0.5 score on a scale | Standard Deviation 0.84 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 3 | -0.8 score on a scale | Standard Deviation 0.9 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 4 | -1.2 score on a scale | Standard Deviation 1.09 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 5 | -1.2 score on a scale | Standard Deviation 1.1 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 6 | -1.6 score on a scale | Standard Deviation 1.12 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 7 | -1.4 score on a scale | Standard Deviation 1.16 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 8 | -1.7 score on a scale | Standard Deviation 1.14 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 15 | -2.0 score on a scale | Standard Deviation 1.07 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 21 | -1.8 score on a scale | Standard Deviation 1.09 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 28 | -1.7 score on a scale | Standard Deviation 1.22 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 35 | -1.7 score on a scale | Standard Deviation 1.15 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Depressed Mood: CFB at Day 42 | -1.7 score on a scale | Standard Deviation 1.2 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: Baseline | 3.1 score on a scale | Standard Deviation 0.33 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 7 | -0.7 score on a scale | Standard Deviation 0.94 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 3 | -1.0 score on a scale | Standard Deviation 1.18 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 4 | -1.1 score on a scale | Standard Deviation 1.12 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 5 | -1.3 score on a scale | Standard Deviation 1.28 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 6 | -1.4 score on a scale | Standard Deviation 1.27 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 7 | -1.4 score on a scale | Standard Deviation 1.2 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 8 | -1.6 score on a scale | Standard Deviation 1.22 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 15 | -2.1 score on a scale | Standard Deviation 1.18 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 21 | -1.9 score on a scale | Standard Deviation 1.09 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 28 | -1.8 score on a scale | Standard Deviation 1.22 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 35 | -1.8 score on a scale | Standard Deviation 1.31 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Work and Activities: CFB at Day 42 | -1.7 score on a scale | Standard Deviation 1.29 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: Baseline | 1.7 score on a scale | Standard Deviation 0.65 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 2 | -0.5 score on a scale | Standard Deviation 1.08 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 3 | -0.8 score on a scale | Standard Deviation 1.07 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 4 | -0.7 score on a scale | Standard Deviation 1.16 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 5 | -1.0 score on a scale | Standard Deviation 1.13 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 6 | -1.0 score on a scale | Standard Deviation 1.02 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 7 | -1.0 score on a scale | Standard Deviation 1.02 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 8 | -1.2 score on a scale | Standard Deviation 0.9 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 15 | -1.3 score on a scale | Standard Deviation 1 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 21 | -1.2 score on a scale | Standard Deviation 0.94 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 28 | -1.0 score on a scale | Standard Deviation 0.96 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 35 | -1.0 score on a scale | Standard Deviation 1.04 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Early: CFB at Day 42 | -0.9 score on a scale | Standard Deviation 0.98 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: Baseline | 1.7 score on a scale | Standard Deviation 0.64 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 2 | -0.5 score on a scale | Standard Deviation 0.99 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 3 | -1.0 score on a scale | Standard Deviation 0.93 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 4 | -0.9 score on a scale | Standard Deviation 0.97 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 5 | -0.9 score on a scale | Standard Deviation 1.07 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 6 | -0.9 score on a scale | Standard Deviation 1.06 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 7 | -1.0 score on a scale | Standard Deviation 0.95 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 8 | -1.1 score on a scale | Standard Deviation 0.93 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 15 | -1.2 score on a scale | Standard Deviation 0.95 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 21 | -1.2 score on a scale | Standard Deviation 0.86 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 28 | -0.9 score on a scale | Standard Deviation 0.96 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 35 | -0.9 score on a scale | Standard Deviation 0.98 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Middle: CFB at Day 42 | -1.0 score on a scale | Standard Deviation 0.94 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: Baseline | 1.5 score on a scale | Standard Deviation 0.82 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 2 | -0.6 score on a scale | Standard Deviation 1.05 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 3 | -0.7 score on a scale | Standard Deviation 1.24 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 4 | -0.7 score on a scale | Standard Deviation 1.18 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 5 | -0.8 score on a scale | Standard Deviation 1.24 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 6 | -0.9 score on a scale | Standard Deviation 1.22 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 7 | -0.8 score on a scale | Standard Deviation 1.31 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 8 | -0.9 score on a scale | Standard Deviation 1.18 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 15 | -1.1 score on a scale | Standard Deviation 1.13 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 21 | -1.0 score on a scale | Standard Deviation 1.22 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 28 | -1.0 score on a scale | Standard Deviation 1.19 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 35 | -0.9 score on a scale | Standard Deviation 1.21 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Insomnia Late: CFB at Day 42 | -1.1 score on a scale | Standard Deviation 1.01 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: Baseline | 1.6 score on a scale | Standard Deviation 0.68 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 2 | -0.1 score on a scale | Standard Deviation 0.5 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 3 | -0.1 score on a scale | Standard Deviation 0.42 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 4 | -0.1 score on a scale | Standard Deviation 0.67 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 5 | -0.4 score on a scale | Standard Deviation 0.69 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 6 | -0.3 score on a scale | Standard Deviation 0.56 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 7 | -0.6 score on a scale | Standard Deviation 0.72 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 8 | -0.5 score on a scale | Standard Deviation 0.66 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 15 | -0.8 score on a scale | Standard Deviation 0.78 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 21 | -0.9 score on a scale | Standard Deviation 0.8 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 28 | -0.8 score on a scale | Standard Deviation 0.87 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 35 | -0.8 score on a scale | Standard Deviation 0.9 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Genital Symptoms: CFB at Day 42 | -0.7 score on a scale | Standard Deviation 0.86 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: Baseline | 1.5 score on a scale | Standard Deviation 0.76 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 2 | -0.4 score on a scale | Standard Deviation 0.62 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 3 | -0.6 score on a scale | Standard Deviation 0.77 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 4 | -0.7 score on a scale | Standard Deviation 0.73 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 5 | -0.8 score on a scale | Standard Deviation 0.77 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 6 | -0.8 score on a scale | Standard Deviation 0.85 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 7 | -0.9 score on a scale | Standard Deviation 0.89 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 8 | -0.9 score on a scale | Standard Deviation 0.95 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 15 | -1.1 score on a scale | Standard Deviation 0.86 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 21 | -1.1 score on a scale | Standard Deviation 0.89 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 28 | -1.0 score on a scale | Standard Deviation 0.92 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 35 | -1.0 score on a scale | Standard Deviation 0.89 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Somatic Symptoms GI: CFB at Day 42 | -0.9 score on a scale | Standard Deviation 0.84 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: Baseline | 1.1 score on a scale | Standard Deviation 0.86 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 2 | -0.5 score on a scale | Standard Deviation 0.79 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 3 | -0.7 score on a scale | Standard Deviation 0.88 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 4 | -0.7 score on a scale | Standard Deviation 1 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 5 | -0.7 score on a scale | Standard Deviation 0.86 |
| Part B: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at All Time Points - Part B | Loss of Weight: CFB at Day 6 | -0.8 score on a scale | Standard Deviation 0.93 |
Secondary
Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A
The HAM-D comprised individual ratings of the following symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms \[gastrointestinal (GI) and general\], genital symptoms, loss of weight, and insight. The following symptoms were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of the study.
Time frame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28
Population: The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Early: CFB at Day 4 | -1.5 score on a scale | Standard Deviation 0.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Early: CFB at Day 5 | -1.5 score on a scale | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Early: CFB at Day 6 | -1.6 score on a scale | Standard Deviation 0.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Early: CFB at Day 7 | -1.5 score on a scale | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Early: CFB at Day 8 | -1.8 score on a scale | Standard Deviation 0.55 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Early: CFB at Day 15 | -1.8 score on a scale | Standard Deviation 0.55 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Early: CFB at Day 21 | -1.8 score on a scale | Standard Deviation 0.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Early: CFB at Day 28 | -1.5 score on a scale | Standard Deviation 0.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Middle: Baseline | 2.0 score on a scale | Standard Deviation 0 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Middle: CFB at Day 2 | -0.9 score on a scale | Standard Deviation 0.95 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Middle: CFB at Day 3 | -1.1 score on a scale | Standard Deviation 0.76 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Middle: CFB at Day 4 | -1.2 score on a scale | Standard Deviation 0.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Middle: CFB at Day 5 | -1.4 score on a scale | Standard Deviation 0.65 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Middle: CFB at Day 6 | -1.4 score on a scale | Standard Deviation 0.65 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Middle: CFB at Day 7 | -1.5 score on a scale | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Middle: CFB at Day 8 | -1.6 score on a scale | Standard Deviation 0.65 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Middle: CFB at Day 15 | -1.7 score on a scale | Standard Deviation 0.48 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Middle: CFB at Day 21 | -1.5 score on a scale | Standard Deviation 0.66 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Middle: CFB at Day 28 | -1.5 score on a scale | Standard Deviation 0.66 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Late: Baseline | 1.8 score on a scale | Standard Deviation 0.38 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Late: CFB at Day 2 | -0.8 score on a scale | Standard Deviation 0.93 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Late: CFB at Day 3 | -0.8 score on a scale | Standard Deviation 0.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Late: CFB at Day 4 | -1.0 score on a scale | Standard Deviation 0.82 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Late: CFB at Day 5 | -1.3 score on a scale | Standard Deviation 0.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Late: CFB at Day 6 | -1.2 score on a scale | Standard Deviation 0.93 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Late: CFB at Day 7 | -1.3 score on a scale | Standard Deviation 0.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Late: CFB at Day 8 | -1.3 score on a scale | Standard Deviation 0.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Late: CFB at Day 15 | -1.5 score on a scale | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Late: CFB at Day 21 | -1.5 score on a scale | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Late: CFB at Day 28 | -1.4 score on a scale | Standard Deviation 0.96 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Genital Symptoms: Baseline | 2.0 score on a scale | Standard Deviation 0 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Genital Symptoms: CFB at Day 2 | -0.1 score on a scale | Standard Deviation 0.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Genital Symptoms: CFB at Day 3 | -0.1 score on a scale | Standard Deviation 0.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Genital Symptoms: CFB at Day 4 | -0.2 score on a scale | Standard Deviation 0.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Genital Symptoms: CFB at Day 5 | -0.3 score on a scale | Standard Deviation 0.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Genital Symptoms: CFB at Day 6 | -0.5 score on a scale | Standard Deviation 0.66 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Genital Symptoms: CFB at Day 7 | -0.5 score on a scale | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Genital Symptoms: CFB at Day 8 | -0.6 score on a scale | Standard Deviation 0.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Genital Symptoms: CFB at Day 15 | -0.8 score on a scale | Standard Deviation 0.73 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Genital Symptoms: CFB at Day 21 | -1.3 score on a scale | Standard Deviation 0.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Genital Symptoms: CFB at Day 28 | -1.3 score on a scale | Standard Deviation 0.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms GI: Baseline | 1.3 score on a scale | Standard Deviation 0.75 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms GI: CFB at Day 2 | -0.3 score on a scale | Standard Deviation 0.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms GI: CFB at Day 3 | -0.7 score on a scale | Standard Deviation 0.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms GI: CFB at Day 4 | -0.8 score on a scale | Standard Deviation 0.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms GI: CFB at Day 5 | -0.8 score on a scale | Standard Deviation 0.73 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms GI: CFB at Day 6 | -0.9 score on a scale | Standard Deviation 0.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms GI: CFB at Day 7 | -0.8 score on a scale | Standard Deviation 0.69 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms GI: CFB at Day 8 | -0.9 score on a scale | Standard Deviation 0.76 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms GI: CFB at Day 15 | -1.0 score on a scale | Standard Deviation 0.82 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms GI: CFB at Day 21 | -1.1 score on a scale | Standard Deviation 0.76 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms GI: CFB at Day 28 | -1.0 score on a scale | Standard Deviation 0.82 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Loss of Weight: Baseline | 0.5 score on a scale | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Loss of Weight: CFB at Day 2 | -0.5 score on a scale | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Loss of Weight: CFB at Day 3 | -0.4 score on a scale | Standard Deviation 0.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Loss of Weight: CFB at Day 4 | -0.4 score on a scale | Standard Deviation 0.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Loss of Weight: CFB at Day 5 | -0.4 score on a scale | Standard Deviation 0.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Loss of Weight: CFB at Day 6 | -0.5 score on a scale | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Loss of Weight: CFB at Day 7 | -0.5 score on a scale | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Loss of Weight: CFB at Day 8 | -0.4 score on a scale | Standard Deviation 0.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Depressed Mood: Baseline | 3.2 score on a scale | Standard Deviation 0.55 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Depressed Mood: CFB at Day 2 | -0.2 score on a scale | Standard Deviation 0.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Depressed Mood: CFB at Day 3 | -0.8 score on a scale | Standard Deviation 0.83 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Loss of Weight: CFB at Day 15 | -0.3 score on a scale | Standard Deviation 0.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Depressed Mood: CFB at Day 4 | -1.3 score on a scale | Standard Deviation 1.18 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Depressed Mood: CFB at Day 5 | -1.4 score on a scale | Standard Deviation 1.33 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Depressed Mood: CFB at Day 6 | -1.6 score on a scale | Standard Deviation 1.19 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Depressed Mood: CFB at Day 7 | -1.6 score on a scale | Standard Deviation 1.19 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Loss of Weight: CFB at Day 21 | -0.5 score on a scale | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Loss of Weight: CFB at Day 28 | -0.5 score on a scale | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms General: Baseline | 1.9 score on a scale | Standard Deviation 0.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms General: CFB at Day 2 | -0.3 score on a scale | Standard Deviation 0.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms General: CFB at Day 3 | -0.4 score on a scale | Standard Deviation 0.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms General: CFB at Day 4 | -0.7 score on a scale | Standard Deviation 0.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms General: CFB at Day 5 | -0.8 score on a scale | Standard Deviation 0.83 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms General: CFB at Day 6 | -0.7 score on a scale | Standard Deviation 0.95 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms General: CFB at Day 7 | -0.8 score on a scale | Standard Deviation 0.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms General: CFB at Day 8 | -1.0 score on a scale | Standard Deviation 0.82 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms General: CFB at Day 15 | -1.2 score on a scale | Standard Deviation 0.73 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Depressed Mood: CFB at Day 8 | -1.8 score on a scale | Standard Deviation 1.14 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Depressed Mood: CFB at Day 15 | -2.2 score on a scale | Standard Deviation 1.07 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms General: CFB at Day 21 | -1.2 score on a scale | Standard Deviation 0.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Depressed Mood: CFB at Day 21 | -2.2 score on a scale | Standard Deviation 1.24 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Depressed Mood: CFB at Day 28 | -2.0 score on a scale | Standard Deviation 1.29 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Work and Activities: Baseline | 3.1 score on a scale | Standard Deviation 0.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Work and Activities: CFB at Day 2 | -0.3 score on a scale | Standard Deviation 0.48 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Work and Activities: CFB at Day 3 | -0.7 score on a scale | Standard Deviation 0.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Work and Activities: CFB at Day 4 | -0.9 score on a scale | Standard Deviation 0.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Somatic Symptoms General: CFB at Day 28 | -1.2 score on a scale | Standard Deviation 0.9 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Work and Activities: CFB at Day 5 | -1.4 score on a scale | Standard Deviation 0.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Feelings of Guilt: Baseline | 1.7 score on a scale | Standard Deviation 0.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Feelings of Guilt: CFB at Day 2 | -0.1 score on a scale | Standard Deviation 0.49 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Agitation: CFB at Day 7 | -0.9 score on a scale | Standard Deviation 0.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Feelings of Guilt: CFB at Day 3 | -0.3 score on a scale | Standard Deviation 1.03 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Feelings of Guilt: CFB at Day 4 | -0.8 score on a scale | Standard Deviation 0.83 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Feelings of Guilt: CFB at Day 5 | -0.8 score on a scale | Standard Deviation 0.99 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Feelings of Guilt: CFB at Day 6 | -1.1 score on a scale | Standard Deviation 0.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Feelings of Guilt: CFB at Day 7 | -1.0 score on a scale | Standard Deviation 0.91 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Feelings of Guilt: CFB at Day 8 | -1.2 score on a scale | Standard Deviation 0.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Feelings of Guilt: CFB at Day 15 | -1.3 score on a scale | Standard Deviation 0.75 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Feelings of Guilt: CFB at Day 21 | -1.4 score on a scale | Standard Deviation 0.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Feelings of Guilt: CFB at Day 28 | -1.4 score on a scale | Standard Deviation 0.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Suicide: Baseline | 0.1 score on a scale | Standard Deviation 0.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Suicide: CFB at Day 2 | -0.1 score on a scale | Standard Deviation 0.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Suicide: CFB at Day 3 | -0.1 score on a scale | Standard Deviation 0.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Suicide: CFB at Day 4 | -0.1 score on a scale | Standard Deviation 0.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Suicide: CFB at Day 5 | -0.1 score on a scale | Standard Deviation 0.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Suicide: CFB at Day 6 | -0.1 score on a scale | Standard Deviation 0.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Suicide: CFB at Day 7 | -0.1 score on a scale | Standard Deviation 0.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Suicide: CFB at Day 8 | -0.1 score on a scale | Standard Deviation 0.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Suicide: CFB at Day 15 | -0.1 score on a scale | Standard Deviation 0.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Suicide: CFB at Day 21 | -0.1 score on a scale | Standard Deviation 0.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Suicide: CFB at Day 28 | -0.1 score on a scale | Standard Deviation 0.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Psychic: Baseline | 2.7 score on a scale | Standard Deviation 0.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Psychic: CFB at Day 2 | -0.5 score on a scale | Standard Deviation 0.52 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Psychic: CFB at Day 3 | -0.8 score on a scale | Standard Deviation 0.55 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Psychic: CFB at Day 4 | -1.3 score on a scale | Standard Deviation 0.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Psychic: CFB at Day 5 | -1.4 score on a scale | Standard Deviation 0.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Psychic: CFB at Day 6 | -1.8 score on a scale | Standard Deviation 1.09 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Psychic: CFB at Day 7 | -1.7 score on a scale | Standard Deviation 1.03 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Psychic: CFB at Day 8 | -1.8 score on a scale | Standard Deviation 0.99 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Psychic: CFB at Day 15 | -1.9 score on a scale | Standard Deviation 0.95 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Psychic: CFB at Day 21 | -1.7 score on a scale | Standard Deviation 0.95 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Psychic: CFB at Day 28 | -1.5 score on a scale | Standard Deviation 0.97 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Somatic: Baseline | 1.5 score on a scale | Standard Deviation 0.66 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Somatic: CFB at Day 2 | -0.2 score on a scale | Standard Deviation 0.55 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Somatic: CFB at Day 3 | -0.2 score on a scale | Standard Deviation 0.73 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Somatic: CFB at Day 4 | -0.5 score on a scale | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Somatic: CFB at Day 5 | -0.8 score on a scale | Standard Deviation 0.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Somatic: CFB at Day 6 | -0.8 score on a scale | Standard Deviation 0.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Somatic: CFB at Day 7 | -0.8 score on a scale | Standard Deviation 0.69 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Somatic: CFB at Day 8 | -0.8 score on a scale | Standard Deviation 0.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Somatic: CFB at Day 15 | -1.1 score on a scale | Standard Deviation 0.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Somatic: CFB at Day 21 | -1.1 score on a scale | Standard Deviation 0.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Anxiety Somatic: CFB at Day 28 | -1.2 score on a scale | Standard Deviation 0.69 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Hypochondriasis: Baseline | 1.1 score on a scale | Standard Deviation 0.76 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Hypochondriasis: CFB at Day 2 | -0.2 score on a scale | Standard Deviation 0.9 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Hypochondriasis: CFB at Day 3 | -0.2 score on a scale | Standard Deviation 0.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Hypochondriasis: CFB at Day 4 | -0.3 score on a scale | Standard Deviation 0.48 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Hypochondriasis: CFB at Day 5 | -0.4 score on a scale | Standard Deviation 0.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Hypochondriasis: CFB at Day 6 | -0.6 score on a scale | Standard Deviation 0.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Hypochondriasis: CFB at Day 7 | -0.5 score on a scale | Standard Deviation 0.52 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Hypochondriasis: CFB at Day 8 | -0.8 score on a scale | Standard Deviation 0.55 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Hypochondriasis: CFB at Day 15 | -0.6 score on a scale | Standard Deviation 0.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Hypochondriasis: CFB at Day 21 | -0.7 score on a scale | Standard Deviation 0.75 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Hypochondriasis: CFB at Day 28 | -0.8 score on a scale | Standard Deviation 0.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insight: Baseline | 0.2 score on a scale | Standard Deviation 0.38 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insight: CFB at Day 2 | -0.1 score on a scale | Standard Deviation 0.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insight: CFB at Day 3 | -0.1 score on a scale | Standard Deviation 0.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insight: CFB at Day 4 | -0.2 score on a scale | Standard Deviation 0.38 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insight: CFB at Day 5 | -0.2 score on a scale | Standard Deviation 0.38 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insight: CFB at Day 6 | -0.2 score on a scale | Standard Deviation 0.38 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insight: CFB at Day 7 | -0.2 score on a scale | Standard Deviation 0.38 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insight: CFB at Day 8 | -0.2 score on a scale | Standard Deviation 0.38 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insight: CFB at Day 15 | -0.2 score on a scale | Standard Deviation 0.38 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insight: CFB at Day 21 | -0.2 score on a scale | Standard Deviation 0.38 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insight: CFB at Day 28 | -0.2 score on a scale | Standard Deviation 0.38 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Agitation: Baseline | 1.4 score on a scale | Standard Deviation 0.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Agitation: CFB at Day 2 | -0.2 score on a scale | Standard Deviation 0.44 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Agitation: CFB at Day 3 | -0.6 score on a scale | Standard Deviation 0.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Agitation: CFB at Day 4 | -0.8 score on a scale | Standard Deviation 0.83 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Agitation: CFB at Day 5 | -0.8 score on a scale | Standard Deviation 0.9 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Agitation: CFB at Day 6 | -0.8 score on a scale | Standard Deviation 0.69 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Agitation: CFB at Day 8 | -1.0 score on a scale | Standard Deviation 0.71 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Agitation: CFB at Day 15 | -0.9 score on a scale | Standard Deviation 0.76 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Agitation: CFB at Day 21 | -1.1 score on a scale | Standard Deviation 0.76 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Agitation: CFB at Day 28 | -1.0 score on a scale | Standard Deviation 0.91 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Retardation: Baseline | 1.0 score on a scale | Standard Deviation 0.71 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Retardation: CFB at Day 2 | -0.4 score on a scale | Standard Deviation 0.65 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Retardation: CFB at Day 3 | -0.6 score on a scale | Standard Deviation 0.65 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Retardation: CFB at Day 4 | -0.6 score on a scale | Standard Deviation 0.65 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Retardation: CFB at Day 5 | -0.7 score on a scale | Standard Deviation 0.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Retardation: CFB at Day 6 | -0.9 score on a scale | Standard Deviation 0.76 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Retardation: CFB at Day 7 | -0.8 score on a scale | Standard Deviation 0.69 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Retardation: CFB at Day 8 | -0.8 score on a scale | Standard Deviation 0.69 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Retardation: CFB at Day 15 | -0.9 score on a scale | Standard Deviation 0.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Retardation: CFB at Day 21 | -1.0 score on a scale | Standard Deviation 0.71 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Retardation: CFB at Day 28 | -1.0 score on a scale | Standard Deviation 0.71 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Work and Activities: CFB at Day 6 | -1.4 score on a scale | Standard Deviation 0.96 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Work and Activities: CFB at Day 7 | -1.5 score on a scale | Standard Deviation 1.13 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Work and Activities: CFB at Day 8 | -1.8 score on a scale | Standard Deviation 1.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Work and Activities: CFB at Day 15 | -2.5 score on a scale | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Work and Activities: CFB at Day 21 | -2.3 score on a scale | Standard Deviation 1.11 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Work and Activities: CFB at Day 28 | -2.2 score on a scale | Standard Deviation 1.3 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Early: Baseline | 1.8 score on a scale | Standard Deviation 0.55 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Early: CFB at Day 2 | -0.9 score on a scale | Standard Deviation 0.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in HAM-D Individual Item Scores at Day 15 and All Other Time Points - Part A | Insomnia Early: CFB at Day 3 | -1.2 score on a scale | Standard Deviation 0.9 |
Secondary
Change From Baseline (CFB) in Heart Rate - Part B
Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination.
Time frame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Follow-up Day 35 | -3.8 beats/min | Standard Deviation 11.13 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 9: Predose | 7.7 beats/min | Standard Deviation 10.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Follow-up Day 42 | -3.7 beats/min | Standard Deviation 11.93 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 5: 12 H Postdose | -0.2 beats/min | Standard Deviation 14.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | Baseline | 74.3 beats/min | Standard Deviation 12.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 9: 1 H Postdose | 5.9 beats/min | Standard Deviation 10.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 1: 0.25 H Postdose | -1.9 beats/min | Standard Deviation 9.96 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 7: 0.25 H Postdose | 3.9 beats/min | Standard Deviation 12 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 1: 0.5 H Postdose | -2.1 beats/min | Standard Deviation 10.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 10: Predose | 6.4 beats/min | Standard Deviation 11.4 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 1: 1 H Postdose | -1.8 beats/min | Standard Deviation 11.14 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 6: 1 H Postdose | 3.2 beats/min | Standard Deviation 12.71 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 1: 2 H Postdose | -0.8 beats/min | Standard Deviation 12.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 10: 1 H Postdose | 4.0 beats/min | Standard Deviation 12.11 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 1: 12 H Postdose | -1.0 beats/min | Standard Deviation 11.53 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 7: 0.5 H Postdose | 3.7 beats/min | Standard Deviation 12.25 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 2: Predose | 2.5 beats/min | Standard Deviation 11.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 11: Predose | 6.2 beats/min | Standard Deviation 15.1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 2: 0.25 H Postdose | -0.2 beats/min | Standard Deviation 10.75 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 6: 0.25 H Postdose | 3.1 beats/min | Standard Deviation 11.3 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 2: 0.5 H Postdose | -1.0 beats/min | Standard Deviation 10.98 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 11: 1 H Postdose | 4.3 beats/min | Standard Deviation 14.76 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 2: 1 H Postdose | -0.2 beats/min | Standard Deviation 11.79 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 7: 1 H Postdose | 5.5 beats/min | Standard Deviation 13.3 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 2: 2 H Postdose | -1.7 beats/min | Standard Deviation 8.5 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 12: Predose | 4.4 beats/min | Standard Deviation 11.99 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 2: 12 H Postdose | -2.3 beats/min | Standard Deviation 11.09 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 6: 2 H Postdose | 2.6 beats/min | Standard Deviation 9.7 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 3: Predose | 2.5 beats/min | Standard Deviation 12.4 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 12: 1 H Postdose | 4.8 beats/min | Standard Deviation 13.56 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 3: 0.25 H Postdose | 0.0 beats/min | Standard Deviation 9.56 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 7: 2 H Postdose | 0.9 beats/min | Standard Deviation 10.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 3: 0.5 H Postdose | -0.5 beats/min | Standard Deviation 10.82 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 13: Predose | 3.1 beats/min | Standard Deviation 12.72 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 3: 1 H Postdose | 0.8 beats/min | Standard Deviation 10.24 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 6: Predose | 4.7 beats/min | Standard Deviation 10.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 3: 2 H Postdose | 0.4 beats/min | Standard Deviation 12.45 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 13: 1 H Postdose | 2.9 beats/min | Standard Deviation 10.46 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 3: 12 H Postdose | -3.0 beats/min | Standard Deviation 10.46 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 7: 12 H Postdose | -0.4 beats/min | Standard Deviation 11.53 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 4: Predose | 4.9 beats/min | Standard Deviation 10.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 14: Predose | 6.4 beats/min | Standard Deviation 12.18 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 4: 0.25 H Postdose | 2.8 beats/min | Standard Deviation 9.06 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 6: 12 H Postdose | 1.4 beats/min | Standard Deviation 12.65 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 4: 0.5 H Postdose | 1.9 beats/min | Standard Deviation 10.43 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 14: 1 H Postdose | 3.6 beats/min | Standard Deviation 10.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 4: 1 H Postdose | 1.4 beats/min | Standard Deviation 9.75 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 8: Predose | 10.1 beats/min | Standard Deviation 14.9 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 4: 2 H Postdose | 1.1 beats/min | Standard Deviation 11.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 15/ET | -1.6 beats/min | Standard Deviation 12.73 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 4: 12 H Postdose | -0.6 beats/min | Standard Deviation 11.36 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 6: 0.5 H Postdose | 2.5 beats/min | Standard Deviation 11.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 5: Predose | 4.3 beats/min | Standard Deviation 11.14 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Follow-up Day 21 | 0.1 beats/min | Standard Deviation 10.32 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 5: 0.25 H Postdose | 2.4 beats/min | Standard Deviation 11.59 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 8: 1 H Postdose | 8.5 beats/min | Standard Deviation 12.78 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 5: 0.5 H Postdose | 3.7 beats/min | Standard Deviation 11.81 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Follow-up Day 28 | -0.5 beats/min | Standard Deviation 13.06 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 5: 1 H Postdose | 0.6 beats/min | Standard Deviation 10.52 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 7: Predose | 3.7 beats/min | Standard Deviation 10.26 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 5: 2 H Postdose | 1.5 beats/min | Standard Deviation 11.68 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 1: 12 H Postdose | -4.3 beats/min | Standard Deviation 12.18 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 5: 12 H Postdose | -1.4 beats/min | Standard Deviation 12.45 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 6: Predose | 3.9 beats/min | Standard Deviation 8 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 6: 0.25 H Postdose | 0.7 beats/min | Standard Deviation 9.81 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 6: 0.5 H Postdose | 0.4 beats/min | Standard Deviation 10.44 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 6: 1 H Postdose | 0.4 beats/min | Standard Deviation 8.54 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 6: 2 H Postdose | 0.5 beats/min | Standard Deviation 11.53 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 6: 12 H Postdose | -2.3 beats/min | Standard Deviation 12.57 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 7: Predose | 3.0 beats/min | Standard Deviation 11.63 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 7: 0.25 H Postdose | 1.5 beats/min | Standard Deviation 11.16 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 7: 0.5 H Postdose | -0.4 beats/min | Standard Deviation 11.19 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 7: 1 H Postdose | 1.4 beats/min | Standard Deviation 11.25 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 7: 2 H Postdose | 2.2 beats/min | Standard Deviation 13.04 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 7: 12 H Postdose | -1.3 beats/min | Standard Deviation 13.75 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 8: Predose | 6.9 beats/min | Standard Deviation 14.46 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 8: 1 H Postdose | 6.9 beats/min | Standard Deviation 12.02 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 9: Predose | 7.5 beats/min | Standard Deviation 12 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 9: 1 H Postdose | 4.4 beats/min | Standard Deviation 12.05 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 10: Predose | 8.9 beats/min | Standard Deviation 13.59 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 10: 1 H Postdose | 6.1 beats/min | Standard Deviation 13.09 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 11: Predose | 4.6 beats/min | Standard Deviation 11.26 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 11: 1 H Postdose | 4.5 beats/min | Standard Deviation 11.22 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 12: Predose | 3.8 beats/min | Standard Deviation 13.85 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 12: 1 H Postdose | 2.1 beats/min | Standard Deviation 13.19 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 13: Predose | 4.1 beats/min | Standard Deviation 11.22 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 13: 1 H Postdose | 5.0 beats/min | Standard Deviation 11.53 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 14: Predose | 4.6 beats/min | Standard Deviation 10.91 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 14: 1 H Postdose | 2.8 beats/min | Standard Deviation 9.96 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 15/ET | -0.1 beats/min | Standard Deviation 10.78 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Follow-up Day 21 | -5.9 beats/min | Standard Deviation 10.54 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Follow-up Day 28 | -5.3 beats/min | Standard Deviation 15.54 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Follow-up Day 35 | -3.9 beats/min | Standard Deviation 13.47 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Follow-up Day 42 | -6.0 beats/min | Standard Deviation 12.73 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | Baseline | 76.8 beats/min | Standard Deviation 12.33 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 1: 0.25 H Postdose | -2.8 beats/min | Standard Deviation 8.5 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 1: 0.5 H Postdose | -2.5 beats/min | Standard Deviation 9.26 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 1: 1 H Postdose | -4.6 beats/min | Standard Deviation 9.13 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 1: 2 H Postdose | -1.1 beats/min | Standard Deviation 9.3 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 5: 2 H Postdose | 2.5 beats/min | Standard Deviation 10.62 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 2: Predose | -1.8 beats/min | Standard Deviation 11.47 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 2: 0.25 H Postdose | -1.8 beats/min | Standard Deviation 11.79 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 2: 0.5 H Postdose | -2.4 beats/min | Standard Deviation 10.5 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 2: 1 H Postdose | -3.0 beats/min | Standard Deviation 11.15 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 2: 2 H Postdose | -1.3 beats/min | Standard Deviation 11.5 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 2: 12 H Postdose | -4.0 beats/min | Standard Deviation 11.51 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 3: Predose | -0.7 beats/min | Standard Deviation 13.35 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 3: 0.25 H Postdose | -1.4 beats/min | Standard Deviation 10.93 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 3: 0.5 H Postdose | -1.8 beats/min | Standard Deviation 11.57 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 3: 1 H Postdose | -1.2 beats/min | Standard Deviation 11.03 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 3: 2 H Postdose | -0.5 beats/min | Standard Deviation 11.19 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 3: 12 H Postdose | -4.2 beats/min | Standard Deviation 11.62 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 4: Predose | 2.0 beats/min | Standard Deviation 10.3 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 4: 0.25 H Postdose | 3.5 beats/min | Standard Deviation 15.13 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 4: 0.5 H Postdose | -1.4 beats/min | Standard Deviation 10.73 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 4: 1 H Postdose | -0.8 beats/min | Standard Deviation 10.63 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 4: 2 H Postdose | 1.6 beats/min | Standard Deviation 12.66 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 4: 12 H Postdose | -3.6 beats/min | Standard Deviation 11.76 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 5: Predose | 1.9 beats/min | Standard Deviation 9.7 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 5: 0.25 H Postdose | 0.3 beats/min | Standard Deviation 12.44 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 5: 0.5 H Postdose | 0.0 beats/min | Standard Deviation 9.57 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Heart Rate - Part B | CFB at Day 5: 1 H Postdose | 2.0 beats/min | Standard Deviation 12.34 |
Secondary
Change From Baseline (CFB) in Oral Temperature - Part B
Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination.
Time frame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 4: Predose | -0.14 degrees C | Standard Deviation 0.421 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 1: 1 H Postdose | 0.05 degrees C | Standard Deviation 0.311 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 4: 0.25 H Postdose | -0.07 degrees C | Standard Deviation 0.335 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 11: 1 H Postdose | -0.05 degrees C | Standard Deviation 0.374 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 4: 0.5 H Postdose | -0.03 degrees C | Standard Deviation 0.414 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 1: 2 H Postdose | 0.03 degrees C | Standard Deviation 0.36 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 4: 1 H Postdose | -0.11 degrees C | Standard Deviation 0.31 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Follow-up Day 21 | -0.12 degrees C | Standard Deviation 0.281 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 4: 2 H Postdose | -0.02 degrees C | Standard Deviation 0.458 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 1: 12 H Postdose | -0.09 degrees C | Standard Deviation 0.328 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 4: 12 H Postdose | -0.07 degrees C | Standard Deviation 0.37 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 13: 1 H Postdose | 0.03 degrees C | Standard Deviation 0.449 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 5: Predose | 0.01 degrees C | Standard Deviation 0.414 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 2: Predose | -0.04 degrees C | Standard Deviation 0.25 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 5: 0.25 H Postdose | 0.01 degrees C | Standard Deviation 0.376 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Follow-up Day 28 | -0.04 degrees C | Standard Deviation 0.321 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 5: 0.5 H Postdose | 0.07 degrees C | Standard Deviation 0.359 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 2: 0.25 H Postdose | -0.03 degrees C | Standard Deviation 0.33 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 5: 1 H Postdose | -0.01 degrees C | Standard Deviation 0.345 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 12: 1 H Postdose | 0.01 degrees C | Standard Deviation 0.364 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 5: 2 H Postdose | -0.04 degrees C | Standard Deviation 0.301 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 2: 0.5 H Postdose | 0.01 degrees C | Standard Deviation 0.284 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 5: 12 H Postdose | -0.09 degrees C | Standard Deviation 0.322 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Follow-up Day 35 | -0.05 degrees C | Standard Deviation 0.324 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 6: Predose | 0.06 degrees C | Standard Deviation 0.381 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 2: 1 H Postdose | -0.05 degrees C | Standard Deviation 0.242 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 6: 0.25 H Postdose | 0.01 degrees C | Standard Deviation 0.381 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 14: Predose | 0.06 degrees C | Standard Deviation 0.416 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 6: 0.5 H Postdose | 0.04 degrees C | Standard Deviation 0.401 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 2: 2 H Postdose | -0.06 degrees C | Standard Deviation 0.257 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 6: 1 H Postdose | 0.04 degrees C | Standard Deviation 0.373 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Follow-up Day 42 | 0.03 degrees C | Standard Deviation 0.338 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 6: 2 H Postdose | 0.05 degrees C | Standard Deviation 0.405 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 2: 12 H Postdose | -0.13 degrees C | Standard Deviation 0.307 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 6: 12 H Postdose | -0.10 degrees C | Standard Deviation 0.341 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 12: Predose | 0.01 degrees C | Standard Deviation 0.422 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 7: Predose | 0.02 degrees C | Standard Deviation 0.386 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 3: Predose | -0.03 degrees C | Standard Deviation 0.403 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 7: 0.25 H Postdose | -0.04 degrees C | Standard Deviation 0.341 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | Baseline | 36.72 degrees C | Standard Deviation 0.298 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 7: 0.5 H Postdose | 0.05 degrees C | Standard Deviation 0.402 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 3: 0.25 H Postdose | -0.06 degrees C | Standard Deviation 0.417 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 7: 1 H Postdose | 0.05 degrees C | Standard Deviation 0.388 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 14: 1 H Postdose | 0.06 degrees C | Standard Deviation 0.378 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 7: 2 H Postdose | 0.01 degrees C | Standard Deviation 0.489 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 3: 0.5 H Postdose | 0.08 degrees C | Standard Deviation 0.408 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 7: 12 H Postdose | -0.06 degrees C | Standard Deviation 0.35 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 1: 0.25 H Postdose | 0.03 degrees C | Standard Deviation 0.309 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 8: Predose | 0.05 degrees C | Standard Deviation 0.35 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 3: 1 H Postdose | 0.03 degrees C | Standard Deviation 0.43 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 8: 1 H Postdose | 0.11 degrees C | Standard Deviation 0.372 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 13: Predose | -0.01 degrees C | Standard Deviation 0.348 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 9: Predose | 0.04 degrees C | Standard Deviation 0.421 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 3: 2 H Postdose | -0.03 degrees C | Standard Deviation 0.353 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 9: 1 H Postdose | 0.09 degrees C | Standard Deviation 0.404 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 1: 0.5 H Postdose | 0.03 degrees C | Standard Deviation 0.315 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 10: Predose | -0.01 degrees C | Standard Deviation 0.409 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 3: 12 H Postdose | -0.13 degrees C | Standard Deviation 0.269 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 10: 1 H Postdose | 0.06 degrees C | Standard Deviation 0.454 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 15/ET | -0.09 degrees C | Standard Deviation 0.32 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 11: Predose | -0.02 degrees C | Standard Deviation 0.536 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 5: 0.25 H Postdose | -0.03 degrees C | Standard Deviation 0.349 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 11: 1 H Postdose | -0.10 degrees C | Standard Deviation 0.387 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 12: Predose | -0.06 degrees C | Standard Deviation 0.358 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 12: 1 H Postdose | -0.12 degrees C | Standard Deviation 0.359 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 13: Predose | 0.04 degrees C | Standard Deviation 0.353 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 13: 1 H Postdose | 0.02 degrees C | Standard Deviation 0.418 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 14: Predose | -0.01 degrees C | Standard Deviation 0.315 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 14: 1 H Postdose | 0.00 degrees C | Standard Deviation 0.419 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 15/ET | -0.03 degrees C | Standard Deviation 0.391 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Follow-up Day 21 | -0.03 degrees C | Standard Deviation 0.314 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Follow-up Day 28 | -0.07 degrees C | Standard Deviation 0.352 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Follow-up Day 35 | -0.05 degrees C | Standard Deviation 0.359 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Follow-up Day 42 | -0.08 degrees C | Standard Deviation 0.389 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | Baseline | 36.72 degrees C | Standard Deviation 0.324 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 1: 0.25 H Postdose | 0.03 degrees C | Standard Deviation 0.374 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 1: 0.5 H Postdose | 0.05 degrees C | Standard Deviation 0.367 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 1: 1 H Postdose | -0.02 degrees C | Standard Deviation 0.414 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 1: 2 H Postdose | -0.05 degrees C | Standard Deviation 0.384 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 1: 12 H Postdose | -0.10 degrees C | Standard Deviation 0.382 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 2: Predose | -0.01 degrees C | Standard Deviation 0.283 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 2: 0.25 H Postdose | -0.04 degrees C | Standard Deviation 0.421 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 2: 0.5 H Postdose | -0.06 degrees C | Standard Deviation 0.539 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 2: 1 H Postdose | -0.02 degrees C | Standard Deviation 0.371 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 2: 2 H Postdose | -0.05 degrees C | Standard Deviation 0.327 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 2: 12 H Postdose | -0.06 degrees C | Standard Deviation 0.397 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 3: Predose | -0.02 degrees C | Standard Deviation 0.321 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 3: 0.25 H Postdose | -0.05 degrees C | Standard Deviation 0.332 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 3: 0.5 H Postdose | -0.03 degrees C | Standard Deviation 0.361 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 3: 1 H Postdose | -0.04 degrees C | Standard Deviation 0.33 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 3: 2 H Postdose | 0.00 degrees C | Standard Deviation 0.38 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 3: 12 H Postdose | -0.08 degrees C | Standard Deviation 0.339 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 4: Predose | -0.03 degrees C | Standard Deviation 0.348 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 4: 0.25 H Postdose | -0.04 degrees C | Standard Deviation 0.343 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 4: 0.5 H Postdose | -0.04 degrees C | Standard Deviation 0.333 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 4: 1 H Postdose | 0.01 degrees C | Standard Deviation 0.392 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 4: 2 H Postdose | -0.04 degrees C | Standard Deviation 0.367 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 4: 12 H Postdose | 0.01 degrees C | Standard Deviation 0.586 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 5: Predose | -0.01 degrees C | Standard Deviation 0.343 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 11: Predose | -0.06 degrees C | Standard Deviation 0.382 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 5: 0.5 H Postdose | -0.08 degrees C | Standard Deviation 0.359 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 5: 1 H Postdose | -0.01 degrees C | Standard Deviation 0.354 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 5: 2 H Postdose | -0.08 degrees C | Standard Deviation 0.349 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 5: 12 H Postdose | -0.12 degrees C | Standard Deviation 0.277 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 6: Predose | 0.07 degrees C | Standard Deviation 0.428 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 6: 0.25 H Postdose | 0.04 degrees C | Standard Deviation 0.523 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 6: 0.5 H Postdose | 0.00 degrees C | Standard Deviation 0.376 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 6: 1 H Postdose | -0.05 degrees C | Standard Deviation 0.392 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 6: 2 H Postdose | 0.01 degrees C | Standard Deviation 0.452 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 6: 12 H Postdose | -0.10 degrees C | Standard Deviation 0.366 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 7: Predose | 0.02 degrees C | Standard Deviation 0.43 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 7: 0.25 H Postdose | -0.02 degrees C | Standard Deviation 0.358 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 7: 0.5 H Postdose | 0.00 degrees C | Standard Deviation 0.39 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 7: 1 H Postdose | 0.06 degrees C | Standard Deviation 0.444 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 7: 2 H Postdose | 0.01 degrees C | Standard Deviation 0.387 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 7: 12 H Postdose | -0.10 degrees C | Standard Deviation 0.353 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 8: Predose | 0.02 degrees C | Standard Deviation 0.388 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 8: 1 H Postdose | 0.02 degrees C | Standard Deviation 0.355 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 9: Predose | 0.04 degrees C | Standard Deviation 0.414 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 9: 1 H Postdose | 0.05 degrees C | Standard Deviation 0.389 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 10: Predose | -0.04 degrees C | Standard Deviation 0.402 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oral Temperature - Part B | CFB at Day 10: 1 H Postdose | 0.01 degrees C | Standard Deviation 0.412 |
Secondary
Change From Baseline (CFB) in Oxygen Saturation - Part B
Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination.
Time frame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Day 8 (predose, 1 hour postdose)
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 4: 2 H Postdose | -0.70 percentage of oxygen saturation | Standard Deviation 2.018 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 2: Predose | -0.23 percentage of oxygen saturation | Standard Deviation 1.939 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 4: 12 H Postdose | 0.00 percentage of oxygen saturation | Standard Deviation 2 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 3: Predose | -0.32 percentage of oxygen saturation | Standard Deviation 1.827 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 5: Predose | -0.16 percentage of oxygen saturation | Standard Deviation 1.539 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 1: 0.5 H Postdose | 0.12 percentage of oxygen saturation | Standard Deviation 1.384 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 5: 0.25 H Postdose | 0.20 percentage of oxygen saturation | Standard Deviation 1.407 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 3: 0.25 H Postdose | -0.09 percentage of oxygen saturation | Standard Deviation 1.789 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 5: 0.5 H Postdose | -0.09 percentage of oxygen saturation | Standard Deviation 1.736 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 2: 0.25 H Postdose | -0.23 percentage of oxygen saturation | Standard Deviation 1.915 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 5: 1 H Postdose | -0.07 percentage of oxygen saturation | Standard Deviation 2.161 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 3: 0.5 H Postdose | -0.11 percentage of oxygen saturation | Standard Deviation 1.742 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 5: 2 H Postdose | -0.05 percentage of oxygen saturation | Standard Deviation 1.765 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 1: 2 H Postdose | 0.11 percentage of oxygen saturation | Standard Deviation 1.513 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 5: 12 H Postdose | 0.11 percentage of oxygen saturation | Standard Deviation 1.979 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 3: 1 H Postdose | -0.27 percentage of oxygen saturation | Standard Deviation 1.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 6: Predose | -0.02 percentage of oxygen saturation | Standard Deviation 1.933 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 2: 0.5 H Postdose | -0.20 percentage of oxygen saturation | Standard Deviation 2.041 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 6: 0.25 H Postdose | 0.09 percentage of oxygen saturation | Standard Deviation 1.525 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 3: 2 H Postdose | -0.32 percentage of oxygen saturation | Standard Deviation 2.34 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 6: 0.5 H Postdose | 0.12 percentage of oxygen saturation | Standard Deviation 1.749 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 1: 0.25 H Postdose | -0.11 percentage of oxygen saturation | Standard Deviation 1.768 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 6: 1 H Postdose | 0.09 percentage of oxygen saturation | Standard Deviation 1.849 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 3: 12 H Postdose | 0.14 percentage of oxygen saturation | Standard Deviation 1.959 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 6: 2 H Postdose | -0.07 percentage of oxygen saturation | Standard Deviation 1.92 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 2: 1 H Postdose | -0.09 percentage of oxygen saturation | Standard Deviation 1.902 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 6: 12 H Postdose | 0.37 percentage of oxygen saturation | Standard Deviation 1.852 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 4: Predose | -0.20 percentage of oxygen saturation | Standard Deviation 1.579 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 7: Predose | -0.31 percentage of oxygen saturation | Standard Deviation 1.932 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 1: 12 H Postdose | 0.09 percentage of oxygen saturation | Standard Deviation 1.789 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 7: 0.25 H Postdose | 0.05 percentage of oxygen saturation | Standard Deviation 2.129 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 4: 0.25 H Postdose | 0.09 percentage of oxygen saturation | Standard Deviation 1.709 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 7: 0.5 H Postdose | -0.21 percentage of oxygen saturation | Standard Deviation 2.007 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 2: 2 H Postdose | -0.11 percentage of oxygen saturation | Standard Deviation 1.907 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 7: 1 H Postdose | -0.05 percentage of oxygen saturation | Standard Deviation 1.987 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 4: 0.5 H Postdose | -0.20 percentage of oxygen saturation | Standard Deviation 1.72 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 7: 2 H Postdose | 0.17 percentage of oxygen saturation | Standard Deviation 1.987 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 1: 1 H Postdose | 0.02 percentage of oxygen saturation | Standard Deviation 1.47 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 7: 12 H Postdose | 0.31 percentage of oxygen saturation | Standard Deviation 2.089 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 4: 1 H Postdose | -0.41 percentage of oxygen saturation | Standard Deviation 1.933 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 8: Predose | 0.21 percentage of oxygen saturation | Standard Deviation 1.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 2: 12 H Postdose | -0.34 percentage of oxygen saturation | Standard Deviation 5.278 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 8: 1 H Postdose | 0.08 percentage of oxygen saturation | Standard Deviation 2.005 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | Baseline | 97.95 percentage of oxygen saturation | Standard Deviation 1.509 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 8: 1 H Postdose | -0.67 percentage of oxygen saturation | Standard Deviation 1.789 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | Baseline | 98.02 percentage of oxygen saturation | Standard Deviation 1.485 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 1: 0.25 H Postdose | -0.02 percentage of oxygen saturation | Standard Deviation 1.502 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 1: 0.5 H Postdose | 0.00 percentage of oxygen saturation | Standard Deviation 1.51 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 1: 1 H Postdose | -0.39 percentage of oxygen saturation | Standard Deviation 1.401 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 1: 2 H Postdose | -0.32 percentage of oxygen saturation | Standard Deviation 1.459 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 1: 12 H Postdose | -0.24 percentage of oxygen saturation | Standard Deviation 1.827 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 2: Predose | -0.29 percentage of oxygen saturation | Standard Deviation 1.576 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 2: 0.25 H Postdose | -0.22 percentage of oxygen saturation | Standard Deviation 1.475 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 2: 0.5 H Postdose | -0.44 percentage of oxygen saturation | Standard Deviation 1.726 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 2: 1 H Postdose | -0.38 percentage of oxygen saturation | Standard Deviation 1.762 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 2: 2 H Postdose | -0.36 percentage of oxygen saturation | Standard Deviation 1.654 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 2: 12 H Postdose | -0.47 percentage of oxygen saturation | Standard Deviation 2.599 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 3: Predose | -0.29 percentage of oxygen saturation | Standard Deviation 1.766 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 3: 0.25 H Postdose | -0.32 percentage of oxygen saturation | Standard Deviation 1.695 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 3: 0.5 H Postdose | -0.42 percentage of oxygen saturation | Standard Deviation 1.712 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 3: 1 H Postdose | -0.44 percentage of oxygen saturation | Standard Deviation 1.902 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 3: 2 H Postdose | -0.78 percentage of oxygen saturation | Standard Deviation 1.894 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 3: 12 H Postdose | -0.24 percentage of oxygen saturation | Standard Deviation 1.824 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 4: Predose | -0.27 percentage of oxygen saturation | Standard Deviation 1.643 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 4: 0.25 H Postdose | -0.24 percentage of oxygen saturation | Standard Deviation 1.667 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 4: 0.5 H Postdose | -0.33 percentage of oxygen saturation | Standard Deviation 1.581 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 4: 1 H Postdose | -0.29 percentage of oxygen saturation | Standard Deviation 1.646 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 4: 2 H Postdose | -1.16 percentage of oxygen saturation | Standard Deviation 2.667 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 4: 12 H Postdose | -1.31 percentage of oxygen saturation | Standard Deviation 4.986 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 5: Predose | -0.36 percentage of oxygen saturation | Standard Deviation 2.165 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 5: 0.25 H Postdose | -0.58 percentage of oxygen saturation | Standard Deviation 2.179 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 5: 0.5 H Postdose | -0.49 percentage of oxygen saturation | Standard Deviation 2.564 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 5: 1 H Postdose | -0.61 percentage of oxygen saturation | Standard Deviation 2.895 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 5: 2 H Postdose | -0.62 percentage of oxygen saturation | Standard Deviation 2.338 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 5: 12 H Postdose | 0.09 percentage of oxygen saturation | Standard Deviation 1.856 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 6: Predose | -0.13 percentage of oxygen saturation | Standard Deviation 1.424 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 6: 0.25 H Postdose | -0.02 percentage of oxygen saturation | Standard Deviation 1.631 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 6: 0.5 H Postdose | 0.16 percentage of oxygen saturation | Standard Deviation 1.147 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 6: 1 H Postdose | -0.22 percentage of oxygen saturation | Standard Deviation 1.82 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 6: 2 H Postdose | 0.16 percentage of oxygen saturation | Standard Deviation 1.492 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 6: 12 H Postdose | 0.02 percentage of oxygen saturation | Standard Deviation 1.672 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 7: Predose | -0.16 percentage of oxygen saturation | Standard Deviation 1.656 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 7: 0.25 H Postdose | 0.07 percentage of oxygen saturation | Standard Deviation 1.516 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 7: 0.5 H Postdose | -0.16 percentage of oxygen saturation | Standard Deviation 1.928 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 7: 1 H Postdose | -0.45 percentage of oxygen saturation | Standard Deviation 1.663 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 7: 2 H Postdose | -0.55 percentage of oxygen saturation | Standard Deviation 2.757 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 7: 12 H Postdose | -0.11 percentage of oxygen saturation | Standard Deviation 1.833 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Oxygen Saturation - Part B | CFB at Day 8: Predose | -0.26 percentage of oxygen saturation | Standard Deviation 1.499 |
Secondary
Change From Baseline (CFB) in Respiratory Rate - Part B
Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination.
Time frame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 3: 1 H Postdose | 0.2 breaths/min | Standard Deviation 2.14 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 6: 0.25 H Postdose | 0.6 breaths/min | Standard Deviation 2.11 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | Baseline | 16.7 breaths/min | Standard Deviation 1.72 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 6: 0.5 H Postdose | 0.3 breaths/min | Standard Deviation 1.95 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 3: 2 H Postdose | 0.4 breaths/min | Standard Deviation 1.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 6: 1 H Postdose | 0.3 breaths/min | Standard Deviation 1.71 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 2: 0.5 H Postdose | 0.4 breaths/min | Standard Deviation 1.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 6: 2 H Postdose | 0.5 breaths/min | Standard Deviation 2.18 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 3: 12 H Postdose | 0.0 breaths/min | Standard Deviation 2.33 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 6: 12 H Postdose | 0.1 breaths/min | Standard Deviation 1.92 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 1: 2 H Postdose | 0.4 breaths/min | Standard Deviation 1.66 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 7: Predose | 0.8 breaths/min | Standard Deviation 2.7 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 4: Predose | 0.3 breaths/min | Standard Deviation 1.92 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 7: 0.25 H Postdose | 1.0 breaths/min | Standard Deviation 2.71 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 2: 1 H Postdose | 0.1 breaths/min | Standard Deviation 1.89 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 7: 0.5 H Postdose | 1.1 breaths/min | Standard Deviation 2.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 4: 0.25 H Postdose | 0.4 breaths/min | Standard Deviation 1.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 7: 1 H Postdose | 0.8 breaths/min | Standard Deviation 2.48 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 1: 0.5 H Postdose | 0.4 breaths/min | Standard Deviation 1.08 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 7: 2 H Postdose | 0.5 breaths/min | Standard Deviation 2.26 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 4: 0.5 H Postdose | 0.2 breaths/min | Standard Deviation 2.12 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 7: 12 H Postdose | -0.2 breaths/min | Standard Deviation 1.96 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 2: 2 H Postdose | 0.3 breaths/min | Standard Deviation 1.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 8: Predose | 0.5 breaths/min | Standard Deviation 2.05 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 4: 1 H Postdose | 0.3 breaths/min | Standard Deviation 1.71 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 8: 1 H Postdose | 1.0 breaths/min | Standard Deviation 2.26 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 1: 12 H Postdose | -0.3 breaths/min | Standard Deviation 1.99 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 9: Predose | 0.7 breaths/min | Standard Deviation 2.22 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 4: 2 H Postdose | 0.2 breaths/min | Standard Deviation 1.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 9: 1 H Postdose | 0.4 breaths/min | Standard Deviation 1.91 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 2: 12 H Postdose | -0.2 breaths/min | Standard Deviation 2.14 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 10: Predose | 0.5 breaths/min | Standard Deviation 1.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 4: 12 H Postdose | 0.2 breaths/min | Standard Deviation 2.46 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 10: 1 H Postdose | 0.5 breaths/min | Standard Deviation 2.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 1: 0.25 H Postdose | 0.2 breaths/min | Standard Deviation 1.24 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 11: Predose | 0.3 breaths/min | Standard Deviation 1.97 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 5: Predose | 0.3 breaths/min | Standard Deviation 2.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 11: 1 H Postdose | 0.3 breaths/min | Standard Deviation 2.18 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 3: Predose | 0.0 breaths/min | Standard Deviation 1.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 12: Predose | 0.7 breaths/min | Standard Deviation 2.27 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 5: 0.25 H Postdose | 0.0 breaths/min | Standard Deviation 2.1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 12: 1 H Postdose | 0.6 breaths/min | Standard Deviation 2.05 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 2: Predose | -0.1 breaths/min | Standard Deviation 2.36 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 13: Predose | 1.0 breaths/min | Standard Deviation 1.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 5: 0.5 H Postdose | 0.1 breaths/min | Standard Deviation 2.1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 13: 1 H Postdose | 1.0 breaths/min | Standard Deviation 2.18 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 3: 0.25 H Postdose | 0.0 breaths/min | Standard Deviation 1.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 14: Predose | 0.8 breaths/min | Standard Deviation 2.08 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 5: 1 H Postdose | 0.2 breaths/min | Standard Deviation 2.16 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 14: 1 H Postdose | 0.9 breaths/min | Standard Deviation 1.98 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 1: 1 H Postdose | 0.3 breaths/min | Standard Deviation 1.76 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 15/ET | 1.2 breaths/min | Standard Deviation 8.39 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 5: 2 H Postdose | 0.2 breaths/min | Standard Deviation 2.13 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Follow-up Day 21 | 0.1 breaths/min | Standard Deviation 2.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 3: 0.5 H Postdose | 0.0 breaths/min | Standard Deviation 2 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Follow-up Day 28 | 0.0 breaths/min | Standard Deviation 2.15 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 5: 12 H Postdose | 0.1 breaths/min | Standard Deviation 2.24 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Follow-up Day 35 | 0.0 breaths/min | Standard Deviation 2.4 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 2: 0.25 H Postdose | 0.0 breaths/min | Standard Deviation 1.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Follow-up Day 42 | -0.2 breaths/min | Standard Deviation 2.48 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 6: Predose | 0.5 breaths/min | Standard Deviation 2.02 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Follow-up Day 42 | 0.1 breaths/min | Standard Deviation 1.5 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 1: 0.25 H Postdose | -0.1 breaths/min | Standard Deviation 1.05 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 1: 0.5 H Postdose | 0.0 breaths/min | Standard Deviation 0.71 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 1: 1 H Postdose | 0.1 breaths/min | Standard Deviation 1 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 1: 2 H Postdose | -0.1 breaths/min | Standard Deviation 0.98 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 1: 12 H Postdose | 0.2 breaths/min | Standard Deviation 1.65 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 2: Predose | 0.0 breaths/min | Standard Deviation 1.48 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 2: 0.25 H Postdose | 0.0 breaths/min | Standard Deviation 1.41 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 2: 0.5 H Postdose | 0.1 breaths/min | Standard Deviation 1.59 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 2: 1 H Postdose | -0.2 breaths/min | Standard Deviation 1.4 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 2: 2 H Postdose | 0.0 breaths/min | Standard Deviation 1.45 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 2: 12 H Postdose | 0.0 breaths/min | Standard Deviation 1.83 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 3: Predose | 0.1 breaths/min | Standard Deviation 2.07 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 3: 0.25 H Postdose | 0.0 breaths/min | Standard Deviation 1.52 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 3: 0.5 H Postdose | 0.0 breaths/min | Standard Deviation 1.45 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 3: 1 H Postdose | 0.2 breaths/min | Standard Deviation 1.51 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 3: 2 H Postdose | 0.3 breaths/min | Standard Deviation 1.63 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 3: 12 H Postdose | 0.2 breaths/min | Standard Deviation 1.82 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 4: Predose | -0.1 breaths/min | Standard Deviation 1.75 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 4: 0.25 H Postdose | -0.1 breaths/min | Standard Deviation 2.03 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 4: 0.5 H Postdose | 0.2 breaths/min | Standard Deviation 1.9 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 4: 1 H Postdose | 0.4 breaths/min | Standard Deviation 2.01 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 4: 2 H Postdose | 0.1 breaths/min | Standard Deviation 1.9 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 4: 12 H Postdose | 0.2 breaths/min | Standard Deviation 2.43 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 5: Predose | 0.0 breaths/min | Standard Deviation 1.82 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 5: 0.25 H Postdose | 0.1 breaths/min | Standard Deviation 1.87 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 5: 0.5 H Postdose | 0.0 breaths/min | Standard Deviation 1.82 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 5: 1 H Postdose | 0.2 breaths/min | Standard Deviation 1.66 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 5: 2 H Postdose | 0.1 breaths/min | Standard Deviation 1.9 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 5: 12 H Postdose | 0.4 breaths/min | Standard Deviation 2.01 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 6: Predose | 0.6 breaths/min | Standard Deviation 2.56 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 6: 0.25 H Postdose | 0.2 breaths/min | Standard Deviation 1.85 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 6: 0.5 H Postdose | 0.2 breaths/min | Standard Deviation 1.81 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 6: 1 H Postdose | 0.2 breaths/min | Standard Deviation 2 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 6: 2 H Postdose | 0.4 breaths/min | Standard Deviation 1.84 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 6: 12 H Postdose | 1.4 breaths/min | Standard Deviation 8.64 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 7: Predose | 0.7 breaths/min | Standard Deviation 1.91 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 7: 0.25 H Postdose | 0.0 breaths/min | Standard Deviation 2.01 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 7: 0.5 H Postdose | 0.3 breaths/min | Standard Deviation 1.48 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 7: 1 H Postdose | 0.4 breaths/min | Standard Deviation 1.99 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 7: 2 H Postdose | 0.5 breaths/min | Standard Deviation 1.91 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 7: 12 H Postdose | 0.1 breaths/min | Standard Deviation 1.73 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 8: Predose | 0.4 breaths/min | Standard Deviation 1.88 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 8: 1 H Postdose | 0.4 breaths/min | Standard Deviation 1.65 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 9: Predose | 0.3 breaths/min | Standard Deviation 1.81 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 9: 1 H Postdose | 0.1 breaths/min | Standard Deviation 1.82 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 10: Predose | 0.5 breaths/min | Standard Deviation 2.05 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 10: 1 H Postdose | 0.6 breaths/min | Standard Deviation 1.67 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 11: Predose | 0.5 breaths/min | Standard Deviation 1.99 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 11: 1 H Postdose | 0.3 breaths/min | Standard Deviation 2.04 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 12: Predose | 0.5 breaths/min | Standard Deviation 1.93 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 12: 1 H Postdose | 0.4 breaths/min | Standard Deviation 1.83 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 13: Predose | 0.4 breaths/min | Standard Deviation 1.96 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 13: 1 H Postdose | 0.3 breaths/min | Standard Deviation 1.79 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 14: Predose | 0.1 breaths/min | Standard Deviation 2.89 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 14: 1 H Postdose | 0.4 breaths/min | Standard Deviation 1.61 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Day 15/ET | -0.4 breaths/min | Standard Deviation 1.59 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Follow-up Day 21 | 0.2 breaths/min | Standard Deviation 1.7 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Follow-up Day 28 | 0.0 breaths/min | Standard Deviation 1.88 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | CFB at Follow-up Day 35 | 0.1 breaths/min | Standard Deviation 1.64 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Respiratory Rate - Part B | Baseline | 16.8 breaths/min | Standard Deviation 1.41 |
Secondary
Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B
Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination.
Time frame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | Baseline | 81.9 mmHg | Standard Deviation 9.32 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 1: 0.25 H Postdose | 1.0 mmHg | Standard Deviation 7.45 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 1: 0.5 H Postdose | 0.7 mmHg | Standard Deviation 7.24 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 1: 1 H Postdose | -0.7 mmHg | Standard Deviation 7.75 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 1: 2 H Postdose | 1.5 mmHg | Standard Deviation 7.41 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 1: 12 H Postdose | -0.1 mmHg | Standard Deviation 9.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 2: Predose | -1.5 mmHg | Standard Deviation 8.02 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 2: 0.25 H Postdose | 1.7 mmHg | Standard Deviation 6.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 2: 0.5 H Postdose | -0.2 mmHg | Standard Deviation 7.06 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 2: 1 H Postdose | 0.8 mmHg | Standard Deviation 6.27 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 2: 2 H Postdose | 0.0 mmHg | Standard Deviation 7.65 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 2: 12 H Postdose | -0.1 mmHg | Standard Deviation 7.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 3: Predose | -1.5 mmHg | Standard Deviation 7.83 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 3: 0.25 H Postdose | 1.0 mmHg | Standard Deviation 8.05 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 3: 0.5 H Postdose | 1.3 mmHg | Standard Deviation 8.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 3: 1 H Postdose | 0.3 mmHg | Standard Deviation 8.17 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 3: 2 H Postdose | -0.4 mmHg | Standard Deviation 8.57 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 3: 12 H Postdose | -0.5 mmHg | Standard Deviation 6.72 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 4: Predose | -0.7 mmHg | Standard Deviation 9.7 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 4: 0.25 H Postdose | 0.1 mmHg | Standard Deviation 9.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 4: 0.5 H Postdose | 0.3 mmHg | Standard Deviation 8.49 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 4: 1 H Postdose | 0.2 mmHg | Standard Deviation 8.06 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 4: 2 H Postdose | 0.6 mmHg | Standard Deviation 9.46 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 4: 12 H Postdose | 0.0 mmHg | Standard Deviation 8.35 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 5: Predose | -1.1 mmHg | Standard Deviation 8.74 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 5: 0.25 H Postdose | 0.2 mmHg | Standard Deviation 8.12 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 5: 0.5 H Postdose | -1.1 mmHg | Standard Deviation 10.02 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 5: 1 H Postdose | -0.7 mmHg | Standard Deviation 8.56 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 5: 2 H Postdose | -1.3 mmHg | Standard Deviation 9.05 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 5: 12 H Postdose | -2.1 mmHg | Standard Deviation 8.54 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 6: Predose | -0.9 mmHg | Standard Deviation 9.09 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 6: 0.25 H Postdose | -0.6 mmHg | Standard Deviation 10.69 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 6: 0.5 H Postdose | 0.0 mmHg | Standard Deviation 10.09 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 6: 1 H Postdose | 1.2 mmHg | Standard Deviation 9.07 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 6: 2 H Postdose | 1.0 mmHg | Standard Deviation 9.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 6: 12 H Postdose | -0.7 mmHg | Standard Deviation 7.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 7: Predose | -0.6 mmHg | Standard Deviation 9.33 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 7: 0.25 H Postdose | 2.3 mmHg | Standard Deviation 8.89 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 7: 0.5 H Postdose | 0.1 mmHg | Standard Deviation 11.03 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 7: 1 H Postdose | 0.8 mmHg | Standard Deviation 10.89 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 7: 2 H Postdose | -0.2 mmHg | Standard Deviation 9.69 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 7: 12 H Postdose | -2.7 mmHg | Standard Deviation 7.17 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 8: Predose | -0.3 mmHg | Standard Deviation 9.52 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 8: 1 H Postdose | -0.4 mmHg | Standard Deviation 7.18 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 9: Predose | -1.5 mmHg | Standard Deviation 9.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 9: 1 H Postdose | 0.6 mmHg | Standard Deviation 9.66 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 10: Predose | 0.2 mmHg | Standard Deviation 8.57 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 10: 1 H Postdose | 0.0 mmHg | Standard Deviation 10.47 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 11: Predose | -2.3 mmHg | Standard Deviation 12.73 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 11: 1 H Postdose | -4.3 mmHg | Standard Deviation 12.66 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 12: Predose | 2.1 mmHg | Standard Deviation 9.35 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 12: 1 H Postdose | -1.4 mmHg | Standard Deviation 11.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 13: Predose | 0.0 mmHg | Standard Deviation 9.92 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 13: 1 H Postdose | 0.7 mmHg | Standard Deviation 7.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 14: Predose | -2.8 mmHg | Standard Deviation 9.26 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 14: 1 H Postdose | 1.2 mmHg | Standard Deviation 10.72 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 15/ET | 0.8 mmHg | Standard Deviation 9.09 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Follow-up Day 21 | 1.7 mmHg | Standard Deviation 8.65 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Follow-up Day 28 | -0.3 mmHg | Standard Deviation 7.05 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Follow-up Day 35 | -0.4 mmHg | Standard Deviation 8.34 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Follow-up Day 42 | 0.3 mmHg | Standard Deviation 9.61 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 6: Predose | 1.8 mmHg | Standard Deviation 11.79 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | Baseline | 80.1 mmHg | Standard Deviation 8.26 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 13: 1 H Postdose | -0.8 mmHg | Standard Deviation 9.39 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 1: 0.25 H Postdose | 2.6 mmHg | Standard Deviation 6.06 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 6: 0.25 H Postdose | 3.0 mmHg | Standard Deviation 8.78 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 1: 0.5 H Postdose | 1.5 mmHg | Standard Deviation 7.3 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 10: Predose | 2.0 mmHg | Standard Deviation 10.21 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 1: 1 H Postdose | 0.8 mmHg | Standard Deviation 9.09 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 6: 0.5 H Postdose | 1.3 mmHg | Standard Deviation 12.7 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 1: 2 H Postdose | 0.4 mmHg | Standard Deviation 8.13 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Follow-up Day 21 | 2.3 mmHg | Standard Deviation 8.58 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 1: 12 H Postdose | 0.0 mmHg | Standard Deviation 7.96 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 6: 1 H Postdose | 2.3 mmHg | Standard Deviation 11.84 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 2: Predose | 0.9 mmHg | Standard Deviation 8.07 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 10: 1 H Postdose | 1.7 mmHg | Standard Deviation 12.59 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 2: 0.25 H Postdose | -1.2 mmHg | Standard Deviation 11.02 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 6: 2 H Postdose | 1.7 mmHg | Standard Deviation 9.93 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 2: 0.5 H Postdose | 0.1 mmHg | Standard Deviation 8.21 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 14: Predose | 2.5 mmHg | Standard Deviation 9.59 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 2: 1 H Postdose | -1.8 mmHg | Standard Deviation 8.47 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 6: 12 H Postdose | 1.6 mmHg | Standard Deviation 12.66 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 2: 2 H Postdose | 0.6 mmHg | Standard Deviation 8.05 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 11: Predose | 1.6 mmHg | Standard Deviation 13.81 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 2: 12 H Postdose | 1.1 mmHg | Standard Deviation 9.87 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 7: Predose | -0.5 mmHg | Standard Deviation 8.27 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 3: Predose | -0.4 mmHg | Standard Deviation 8.08 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Follow-up Day 35 | 3.5 mmHg | Standard Deviation 9.6 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 3: 0.25 H Postdose | 0.4 mmHg | Standard Deviation 8.02 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 7: 0.25 H Postdose | 0.2 mmHg | Standard Deviation 9.03 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 3: 0.5 H Postdose | -0.4 mmHg | Standard Deviation 8.11 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 11: 1 H Postdose | 0.0 mmHg | Standard Deviation 10.73 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 3: 1 H Postdose | -0.7 mmHg | Standard Deviation 9.97 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 7: 0.5 H Postdose | 0.7 mmHg | Standard Deviation 11.28 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 3: 2 H Postdose | -0.1 mmHg | Standard Deviation 10.06 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 14: 1 H Postdose | 1.8 mmHg | Standard Deviation 8.36 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 3: 12 H Postdose | -0.4 mmHg | Standard Deviation 8.59 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 7: 1 H Postdose | 0.8 mmHg | Standard Deviation 10.27 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 4: Predose | 2.4 mmHg | Standard Deviation 9.41 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 12: Predose | 1.2 mmHg | Standard Deviation 10.41 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 4: 0.25 H Postdose | 2.2 mmHg | Standard Deviation 9.94 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 7: 2 H Postdose | 0.6 mmHg | Standard Deviation 8.9 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 4: 0.5 H Postdose | 0.2 mmHg | Standard Deviation 9.36 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Follow-up Day 28 | 1.9 mmHg | Standard Deviation 9 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 4: 1 H Postdose | 0.3 mmHg | Standard Deviation 10.05 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 7: 12 H Postdose | 0.4 mmHg | Standard Deviation 9.28 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 4: 2 H Postdose | -0.8 mmHg | Standard Deviation 10.84 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 12: 1 H Postdose | 2.0 mmHg | Standard Deviation 12.93 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 4: 12 H Postdose | -0.6 mmHg | Standard Deviation 9.38 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 8: Predose | 0.7 mmHg | Standard Deviation 9.77 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 5: Predose | -0.2 mmHg | Standard Deviation 8.65 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 15/ET | 1.5 mmHg | Standard Deviation 8.41 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 5: 0.25 H Postdose | 0.6 mmHg | Standard Deviation 9.08 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 8: 1 H Postdose | 2.3 mmHg | Standard Deviation 8.57 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 5: 0.5 H Postdose | 0.8 mmHg | Standard Deviation 9.19 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 13: Predose | 2.1 mmHg | Standard Deviation 8.87 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 5: 1 H Postdose | 1.3 mmHg | Standard Deviation 10.24 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 9: Predose | 0.5 mmHg | Standard Deviation 7.27 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 5: 2 H Postdose | -0.5 mmHg | Standard Deviation 9.62 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Follow-up Day 42 | 2.5 mmHg | Standard Deviation 7.69 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 5: 12 H Postdose | -0.3 mmHg | Standard Deviation 11.77 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Diastolic Blood Pressure - Part B | CFB at Day 9: 1 H Postdose | 1.7 mmHg | Standard Deviation 8.83 |
Secondary
Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B
Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination.
Time frame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | Baseline | 125.9 mmHg | Standard Deviation 14.19 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 1: 0.25 H Postdose | 0.3 mmHg | Standard Deviation 8.48 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 1: 0.5 H Postdose | -0.7 mmHg | Standard Deviation 8.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 1: 1 H Postdose | -0.7 mmHg | Standard Deviation 9.44 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 1: 2 H Postdose | 0.2 mmHg | Standard Deviation 11.68 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 1: 12 H Postdose | -3.8 mmHg | Standard Deviation 13.79 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 2: Predose | -1.3 mmHg | Standard Deviation 9.2 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 2: 0.25 H Postdose | 1.1 mmHg | Standard Deviation 10.1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 2: 0.5 H Postdose | -0.2 mmHg | Standard Deviation 10.16 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 2: 1 H Postdose | -0.7 mmHg | Standard Deviation 11.01 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 2: 2 H Postdose | -1.5 mmHg | Standard Deviation 11.38 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 2: 12 H Postdose | -5.5 mmHg | Standard Deviation 11.62 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 3: Predose | -3.0 mmHg | Standard Deviation 10.48 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 3: 0.25 H Postdose | -0.1 mmHg | Standard Deviation 11.97 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 3: 0.5 H Postdose | -1.0 mmHg | Standard Deviation 12.26 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 3: 1 H Postdose | -0.7 mmHg | Standard Deviation 12.22 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 3: 2 H Postdose | -1.9 mmHg | Standard Deviation 11.45 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 3: 12 H Postdose | -4.3 mmHg | Standard Deviation 8.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 4: Predose | -1.2 mmHg | Standard Deviation 16.11 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 4: 0.25 H Postdose | -1.3 mmHg | Standard Deviation 13.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 4: 0.5 H Postdose | -1.9 mmHg | Standard Deviation 10.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 4: 1 H Postdose | -3.1 mmHg | Standard Deviation 13.79 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 4: 2 H Postdose | -2.5 mmHg | Standard Deviation 13.34 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 4: 12 H Postdose | -5.5 mmHg | Standard Deviation 13.01 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 5: Predose | -1.3 mmHg | Standard Deviation 12.57 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 5: 0.25 H Postdose | -0.5 mmHg | Standard Deviation 11.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 5: 0.5 H Postdose | -1.0 mmHg | Standard Deviation 11.04 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 5: 1 H Postdose | -2.4 mmHg | Standard Deviation 10.89 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 5: 2 H Postdose | -1.6 mmHg | Standard Deviation 13.12 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 5: 12 H Postdose | -5.5 mmHg | Standard Deviation 14.11 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 6: Predose | -4.2 mmHg | Standard Deviation 14.69 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 6: 0.25 H Postdose | -1.6 mmHg | Standard Deviation 11.52 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 6: 0.5 H Postdose | -3.6 mmHg | Standard Deviation 12.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 6: 1 H Postdose | -1.9 mmHg | Standard Deviation 12.98 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 6: 2 H Postdose | -2.9 mmHg | Standard Deviation 12.89 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 6: 12 H Postdose | -5.7 mmHg | Standard Deviation 11.59 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 7: Predose | -2.8 mmHg | Standard Deviation 14.48 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 7: 0.25 H Postdose | -2.6 mmHg | Standard Deviation 15.62 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 7: 0.5 H Postdose | -2.6 mmHg | Standard Deviation 15.42 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 7: 1 H Postdose | -1.5 mmHg | Standard Deviation 15.18 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 7: 2 H Postdose | -2.9 mmHg | Standard Deviation 16.37 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 7: 12 H Postdose | -6.9 mmHg | Standard Deviation 12.84 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 8: Predose | -2.2 mmHg | Standard Deviation 13.37 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 8: 1 H Postdose | -0.9 mmHg | Standard Deviation 10.82 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 9: Predose | -3.9 mmHg | Standard Deviation 13.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 9: 1 H Postdose | -2.6 mmHg | Standard Deviation 14.5 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 10: Predose | -2.1 mmHg | Standard Deviation 16.07 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 10: 1 H Postdose | -1.2 mmHg | Standard Deviation 16.73 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 11: Predose | -4.8 mmHg | Standard Deviation 16.81 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 11: 1 H Postdose | -6.1 mmHg | Standard Deviation 16.18 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 12: Predose | -2.3 mmHg | Standard Deviation 13.7 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 12: 1 H Postdose | -2.5 mmHg | Standard Deviation 13.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 13: Predose | -4.1 mmHg | Standard Deviation 12.65 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 13: 1 H Postdose | -1.6 mmHg | Standard Deviation 10.92 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 14: Predose | -4.4 mmHg | Standard Deviation 12.31 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 14: 1 H Postdose | -1.2 mmHg | Standard Deviation 13.75 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 15/ET | -2.8 mmHg | Standard Deviation 13.56 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Follow-up Day 21 | -1.7 mmHg | Standard Deviation 14.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Follow-up Day 28 | -3.2 mmHg | Standard Deviation 12.13 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Follow-up Day 35 | -1.0 mmHg | Standard Deviation 13 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Follow-up Day 42 | -2.5 mmHg | Standard Deviation 14.02 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 6: Predose | 3.2 mmHg | Standard Deviation 13.5 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | Baseline | 125.1 mmHg | Standard Deviation 14 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 13: 1 H Postdose | 1.8 mmHg | Standard Deviation 11.83 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 1: 0.25 H Postdose | 0.8 mmHg | Standard Deviation 8.2 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 6: 0.25 H Postdose | 2.8 mmHg | Standard Deviation 12.65 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 1: 0.5 H Postdose | -1.7 mmHg | Standard Deviation 12.05 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 10: Predose | -0.7 mmHg | Standard Deviation 11.64 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 1: 1 H Postdose | -0.3 mmHg | Standard Deviation 12.46 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 6: 0.5 H Postdose | 1.7 mmHg | Standard Deviation 14.73 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 1: 2 H Postdose | -2.6 mmHg | Standard Deviation 10.56 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Follow-up Day 21 | 1.7 mmHg | Standard Deviation 12.63 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 1: 12 H Postdose | -4.5 mmHg | Standard Deviation 11.27 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 6: 1 H Postdose | 2.3 mmHg | Standard Deviation 14.61 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 2: Predose | -0.3 mmHg | Standard Deviation 14.5 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 10: 1 H Postdose | -0.6 mmHg | Standard Deviation 16.41 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 2: 0.25 H Postdose | -3.9 mmHg | Standard Deviation 15.98 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 6: 2 H Postdose | 2.2 mmHg | Standard Deviation 13.98 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 2: 0.5 H Postdose | 0.4 mmHg | Standard Deviation 11.25 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 14: Predose | 2.3 mmHg | Standard Deviation 11.6 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 2: 1 H Postdose | -1.8 mmHg | Standard Deviation 10.26 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 6: 12 H Postdose | -1.6 mmHg | Standard Deviation 13.21 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 2: 2 H Postdose | -2.7 mmHg | Standard Deviation 12.51 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 11: Predose | 2.0 mmHg | Standard Deviation 17.24 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 2: 12 H Postdose | -2.4 mmHg | Standard Deviation 12.67 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 7: Predose | 4.3 mmHg | Standard Deviation 15.71 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 3: Predose | 0.1 mmHg | Standard Deviation 13.03 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Follow-up Day 35 | 2.6 mmHg | Standard Deviation 12.04 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 3: 0.25 H Postdose | -0.2 mmHg | Standard Deviation 12.78 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 7: 0.25 H Postdose | 1.2 mmHg | Standard Deviation 13.56 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 3: 0.5 H Postdose | -2.1 mmHg | Standard Deviation 10.83 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 11: 1 H Postdose | -0.1 mmHg | Standard Deviation 12.09 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 3: 1 H Postdose | -1.7 mmHg | Standard Deviation 13.34 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 7: 0.5 H Postdose | 1.0 mmHg | Standard Deviation 11.22 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 3: 2 H Postdose | -1.4 mmHg | Standard Deviation 14.55 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 14: 1 H Postdose | 3.1 mmHg | Standard Deviation 13.9 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 3: 12 H Postdose | -3.4 mmHg | Standard Deviation 11.42 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 7: 1 H Postdose | 1.5 mmHg | Standard Deviation 12.2 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 4: Predose | -0.2 mmHg | Standard Deviation 10.91 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 12: Predose | 2.4 mmHg | Standard Deviation 12.2 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 4: 0.25 H Postdose | 1.6 mmHg | Standard Deviation 11.83 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 7: 2 H Postdose | -1.9 mmHg | Standard Deviation 10.48 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 4: 0.5 H Postdose | -0.4 mmHg | Standard Deviation 9.38 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Follow-up Day 28 | -1.9 mmHg | Standard Deviation 11.32 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 4: 1 H Postdose | 1.2 mmHg | Standard Deviation 10.7 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 7: 12 H Postdose | -3.2 mmHg | Standard Deviation 11.19 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 4: 2 H Postdose | -1.8 mmHg | Standard Deviation 13.77 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 12: 1 H Postdose | 3.1 mmHg | Standard Deviation 14.1 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 4: 12 H Postdose | -4.5 mmHg | Standard Deviation 11.79 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 8: Predose | 1.9 mmHg | Standard Deviation 10.57 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 5: Predose | 1.3 mmHg | Standard Deviation 13.7 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 15/ET | -0.3 mmHg | Standard Deviation 11.32 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 5: 0.25 H Postdose | 1.4 mmHg | Standard Deviation 13.22 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 8: 1 H Postdose | 0.6 mmHg | Standard Deviation 11.49 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 5: 0.5 H Postdose | 1.3 mmHg | Standard Deviation 11.9 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 13: Predose | 0.6 mmHg | Standard Deviation 11.69 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 5: 1 H Postdose | 1.8 mmHg | Standard Deviation 11.63 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 9: Predose | 1.5 mmHg | Standard Deviation 13.77 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 5: 2 H Postdose | -2.2 mmHg | Standard Deviation 12.56 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Follow-up Day 42 | 0.8 mmHg | Standard Deviation 9.94 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 5: 12 H Postdose | -3.5 mmHg | Standard Deviation 13.36 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Standing Systolic Blood Pressure - Part B | CFB at Day 9: 1 H Postdose | 0.8 mmHg | Standard Deviation 11.08 |
Secondary
Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B
Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination.
Time frame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | Baseline | 76.1 mmHg | Standard Deviation 10.1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 1: 0.25 H Postdose | 0.8 mmHg | Standard Deviation 5.04 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 1: 0.5 H Postdose | -0.1 mmHg | Standard Deviation 6.38 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 1: 1 H Postdose | 0.6 mmHg | Standard Deviation 6.4 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 1: 2 H Postdose | 0.8 mmHg | Standard Deviation 7.32 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 1: 12 H Postdose | 1.7 mmHg | Standard Deviation 9.22 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 2: Predose | -0.5 mmHg | Standard Deviation 8.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 2: 0.25 H Postdose | 1.8 mmHg | Standard Deviation 8.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 2: 0.5 H Postdose | 1.6 mmHg | Standard Deviation 7.86 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 2: 1 H Postdose | 2.2 mmHg | Standard Deviation 8.74 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 2: 2 H Postdose | 0.8 mmHg | Standard Deviation 7.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 2: 12 H Postdose | -0.1 mmHg | Standard Deviation 7.15 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 3: Predose | 1.7 mmHg | Standard Deviation 7.35 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 3: 0.25 H Postdose | 3.4 mmHg | Standard Deviation 8.57 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 3: 0.5 H Postdose | 3.0 mmHg | Standard Deviation 7.96 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 3: 1 H Postdose | 1.3 mmHg | Standard Deviation 8.29 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 3: 2 H Postdose | 1.3 mmHg | Standard Deviation 7.97 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 3: 12 H Postdose | -0.5 mmHg | Standard Deviation 7.14 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 4: Predose | 1.9 mmHg | Standard Deviation 9.49 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 4: 0.25 H Postdose | 1.8 mmHg | Standard Deviation 9.53 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 4: 0.5 H Postdose | 0.9 mmHg | Standard Deviation 10.07 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 4: 1 H Postdose | 1.3 mmHg | Standard Deviation 9.83 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 4: 2 H Postdose | 0.3 mmHg | Standard Deviation 9.61 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 4: 12 H Postdose | -0.1 mmHg | Standard Deviation 9.06 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 5: Predose | -1.5 mmHg | Standard Deviation 9.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 5: 0.25 H Postdose | 0.8 mmHg | Standard Deviation 9.99 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 5: 0.5 H Postdose | 1.3 mmHg | Standard Deviation 9.75 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 5: 1 H Postdose | 0.3 mmHg | Standard Deviation 9.49 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 5: 2 H Postdose | 0.8 mmHg | Standard Deviation 10.59 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 5: 12 H Postdose | 0.0 mmHg | Standard Deviation 9.72 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 6: Predose | 1.4 mmHg | Standard Deviation 10.96 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 6: 0.25 H Postdose | 0.6 mmHg | Standard Deviation 10.12 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 6: 0.5 H Postdose | 1.3 mmHg | Standard Deviation 11.29 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 6: 1 H Postdose | 1.5 mmHg | Standard Deviation 9.74 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 6: 2 H Postdose | 2.9 mmHg | Standard Deviation 11.43 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 6: 12 H Postdose | -1.0 mmHg | Standard Deviation 8.3 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 7: Predose | 0.0 mmHg | Standard Deviation 8.25 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 7: 0.25 H Postdose | 1.4 mmHg | Standard Deviation 10.33 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 7: 0.5 H Postdose | 0.2 mmHg | Standard Deviation 10.1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 7: 1 H Postdose | 0.1 mmHg | Standard Deviation 9.03 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 7: 2 H Postdose | 1.3 mmHg | Standard Deviation 11.2 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 7: 12 H Postdose | -0.4 mmHg | Standard Deviation 8.09 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 8: Predose | -0.1 mmHg | Standard Deviation 9.22 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 8: 1 H Postdose | 0.9 mmHg | Standard Deviation 9.85 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 9: Predose | -0.1 mmHg | Standard Deviation 9.03 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 9: 1 H Postdose | 0.4 mmHg | Standard Deviation 9.87 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 10: Predose | -0.5 mmHg | Standard Deviation 10.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 10: 1 H Postdose | 0.8 mmHg | Standard Deviation 9.97 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 11: Predose | -0.5 mmHg | Standard Deviation 11.53 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 11: 1 H Postdose | -2.1 mmHg | Standard Deviation 10.72 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 12: Predose | -1.0 mmHg | Standard Deviation 8.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 12: 1 H Postdose | -0.5 mmHg | Standard Deviation 9.17 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 13: Predose | 0.7 mmHg | Standard Deviation 11.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 13: 1 H Postdose | 2.7 mmHg | Standard Deviation 10.42 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 14: Predose | -3.3 mmHg | Standard Deviation 9.52 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 14: 1 H Postdose | 1.3 mmHg | Standard Deviation 9.96 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 15/ET | 2.4 mmHg | Standard Deviation 10 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Follow-up Day 21 | 2.8 mmHg | Standard Deviation 9.47 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Follow-up Day 28 | 2.9 mmHg | Standard Deviation 9.73 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Follow-up Day 35 | -0.4 mmHg | Standard Deviation 11.31 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Follow-up Day 42 | 0.5 mmHg | Standard Deviation 10.98 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 6: Predose | 2.1 mmHg | Standard Deviation 9.04 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | Baseline | 75.2 mmHg | Standard Deviation 7.91 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 13: 1 H Postdose | -0.1 mmHg | Standard Deviation 8.04 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 1: 0.25 H Postdose | 1.0 mmHg | Standard Deviation 7.26 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 6: 0.25 H Postdose | 2.7 mmHg | Standard Deviation 7.23 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 1: 0.5 H Postdose | 0.6 mmHg | Standard Deviation 7.09 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 10: Predose | 0.7 mmHg | Standard Deviation 10.23 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 1: 1 H Postdose | 0.3 mmHg | Standard Deviation 8.43 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 6: 0.5 H Postdose | 2.0 mmHg | Standard Deviation 8.85 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 1: 2 H Postdose | -0.2 mmHg | Standard Deviation 8.16 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Follow-up Day 21 | 3.9 mmHg | Standard Deviation 9.13 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 1: 12 H Postdose | 0.2 mmHg | Standard Deviation 7.98 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 6: 1 H Postdose | 0.9 mmHg | Standard Deviation 10.62 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 2: Predose | 0.3 mmHg | Standard Deviation 7.21 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 10: 1 H Postdose | -0.5 mmHg | Standard Deviation 9.14 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 2: 0.25 H Postdose | 0.8 mmHg | Standard Deviation 9.53 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 6: 2 H Postdose | 2.7 mmHg | Standard Deviation 11 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 2: 0.5 H Postdose | 0.2 mmHg | Standard Deviation 9.3 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 14: Predose | 1.6 mmHg | Standard Deviation 9.68 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 2: 1 H Postdose | -0.3 mmHg | Standard Deviation 7.97 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 6: 12 H Postdose | 0.4 mmHg | Standard Deviation 10.66 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 2: 2 H Postdose | 1.3 mmHg | Standard Deviation 10.1 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 11: Predose | 0.6 mmHg | Standard Deviation 8.57 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 2: 12 H Postdose | -0.5 mmHg | Standard Deviation 10.11 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 7: Predose | 0.5 mmHg | Standard Deviation 8.78 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 3: Predose | 0.1 mmHg | Standard Deviation 9.03 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Follow-up Day 35 | 4.3 mmHg | Standard Deviation 9.86 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 3: 0.25 H Postdose | 0.6 mmHg | Standard Deviation 8.99 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 7: 0.25 H Postdose | 1.5 mmHg | Standard Deviation 9.49 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 3: 0.5 H Postdose | -0.4 mmHg | Standard Deviation 9.78 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 11: 1 H Postdose | 2.2 mmHg | Standard Deviation 9.15 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 3: 1 H Postdose | 0.0 mmHg | Standard Deviation 10.69 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 7: 0.5 H Postdose | 2.3 mmHg | Standard Deviation 9.66 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 3: 2 H Postdose | -0.7 mmHg | Standard Deviation 10.86 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 14: 1 H Postdose | 2.1 mmHg | Standard Deviation 8.38 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 3: 12 H Postdose | -1.7 mmHg | Standard Deviation 10.42 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 7: 1 H Postdose | 2.0 mmHg | Standard Deviation 9.14 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 4: Predose | 1.5 mmHg | Standard Deviation 9.23 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 12: Predose | 1.1 mmHg | Standard Deviation 7.98 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 4: 0.25 H Postdose | 0.3 mmHg | Standard Deviation 10.77 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 7: 2 H Postdose | 2.1 mmHg | Standard Deviation 9.9 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 4: 0.5 H Postdose | 0.6 mmHg | Standard Deviation 10.5 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Follow-up Day 28 | 3.4 mmHg | Standard Deviation 8.42 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 4: 1 H Postdose | 0.4 mmHg | Standard Deviation 9.16 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 7: 12 H Postdose | 2.0 mmHg | Standard Deviation 10 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 4: 2 H Postdose | 0.9 mmHg | Standard Deviation 10.25 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 12: 1 H Postdose | 0.0 mmHg | Standard Deviation 9.06 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 4: 12 H Postdose | -1.3 mmHg | Standard Deviation 9.86 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 8: Predose | 0.6 mmHg | Standard Deviation 7.76 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 5: Predose | 0.0 mmHg | Standard Deviation 8.94 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 15/ET | 4.1 mmHg | Standard Deviation 8.94 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 5: 0.25 H Postdose | 0.1 mmHg | Standard Deviation 8.78 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 8: 1 H Postdose | 1.9 mmHg | Standard Deviation 9.92 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 5: 0.5 H Postdose | 0.7 mmHg | Standard Deviation 9.12 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 13: Predose | 0.5 mmHg | Standard Deviation 9.33 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 5: 1 H Postdose | 0.3 mmHg | Standard Deviation 9.45 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 9: Predose | 1.0 mmHg | Standard Deviation 8.18 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 5: 2 H Postdose | -1.3 mmHg | Standard Deviation 9.92 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Follow-up Day 42 | 4.6 mmHg | Standard Deviation 10.46 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 5: 12 H Postdose | -1.3 mmHg | Standard Deviation 8.16 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Diastolic Blood Pressure - Part B | CFB at Day 9: 1 H Postdose | -0.5 mmHg | Standard Deviation 10.18 |
Secondary
Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B
Vital signs measures included supine systolic blood pressure, supine diastolic blood pressure, standing systolic blood pressure, standing diastolic blood pressure, heart rate, respiratory rate, oral temperature, and oxygen saturation. The analysis was performed in participants included in Part B of the study. H = Hour(s). ET = Early Termination.
Time frame: Baseline, Day 1 (0.25, 0.5, 1, 2, 12 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2, 12 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | Baseline | 120.5 mmHg | Standard Deviation 15.41 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 1: 0.25 H Postdose | 1.7 mmHg | Standard Deviation 9.33 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 1: 0.5 H Postdose | 1.3 mmHg | Standard Deviation 8.38 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 1: 1 H Postdose | 1.1 mmHg | Standard Deviation 8.63 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 1: 2 H Postdose | 2.3 mmHg | Standard Deviation 11.51 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 1: 12 H Postdose | 0.0 mmHg | Standard Deviation 12.72 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 2: Predose | -0.3 mmHg | Standard Deviation 10.62 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 2: 0.25 H Postdose | 2.7 mmHg | Standard Deviation 12.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 2: 0.5 H Postdose | 1.9 mmHg | Standard Deviation 9.49 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 2: 1 H Postdose | 2.2 mmHg | Standard Deviation 10.83 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 2: 2 H Postdose | 1.7 mmHg | Standard Deviation 11.72 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 2: 12 H Postdose | -1.2 mmHg | Standard Deviation 11.11 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 3: Predose | 1.3 mmHg | Standard Deviation 10.5 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 3: 0.25 H Postdose | 2.4 mmHg | Standard Deviation 10.49 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 3: 0.5 H Postdose | 3.4 mmHg | Standard Deviation 13.8 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 3: 1 H Postdose | 2.2 mmHg | Standard Deviation 10.18 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 3: 2 H Postdose | 1.5 mmHg | Standard Deviation 12.35 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 3: 12 H Postdose | -2.7 mmHg | Standard Deviation 13.22 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 4: Predose | 1.1 mmHg | Standard Deviation 13.77 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 4: 0.25 H Postdose | 1.3 mmHg | Standard Deviation 11.83 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 4: 0.5 H Postdose | 2.2 mmHg | Standard Deviation 12.29 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 4: 1 H Postdose | -0.5 mmHg | Standard Deviation 11.88 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 4: 2 H Postdose | -1.4 mmHg | Standard Deviation 13.06 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 4: 12 H Postdose | -2.8 mmHg | Standard Deviation 14.65 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 5: Predose | -1.9 mmHg | Standard Deviation 12.82 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 5: 0.25 H Postdose | -0.8 mmHg | Standard Deviation 11.6 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 5: 0.5 H Postdose | 0.3 mmHg | Standard Deviation 14.05 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 5: 1 H Postdose | -0.4 mmHg | Standard Deviation 10.26 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 5: 2 H Postdose | 0.8 mmHg | Standard Deviation 10.42 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 5: 12 H Postdose | -1.7 mmHg | Standard Deviation 13.79 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 6: Predose | 0.5 mmHg | Standard Deviation 13.69 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 6: 0.25 H Postdose | 0.9 mmHg | Standard Deviation 12.24 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 6: 0.5 H Postdose | -0.4 mmHg | Standard Deviation 13.01 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 6: 1 H Postdose | 0.5 mmHg | Standard Deviation 12.91 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 6: 2 H Postdose | 2.6 mmHg | Standard Deviation 16.1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 6: 12 H Postdose | -1.6 mmHg | Standard Deviation 11.1 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 7: Predose | -1.0 mmHg | Standard Deviation 12.54 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 7: 0.25 H Postdose | 0.5 mmHg | Standard Deviation 14.43 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 7: 0.5 H Postdose | 0.4 mmHg | Standard Deviation 14.04 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 7: 1 H Postdose | -0.7 mmHg | Standard Deviation 13.83 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 7: 2 H Postdose | 0.2 mmHg | Standard Deviation 15.73 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 7: 12 H Postdose | -3.4 mmHg | Standard Deviation 11.68 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 8: Predose | -0.8 mmHg | Standard Deviation 13.53 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 8: 1 H Postdose | 1.6 mmHg | Standard Deviation 12.35 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 9: Predose | 0.5 mmHg | Standard Deviation 14.43 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 9: 1 H Postdose | 2.8 mmHg | Standard Deviation 16.01 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 10: Predose | 0.0 mmHg | Standard Deviation 14.32 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 10: 1 H Postdose | 0.0 mmHg | Standard Deviation 16.48 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 11: Predose | -2.5 mmHg | Standard Deviation 16.3 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 11: 1 H Postdose | -3.6 mmHg | Standard Deviation 16.84 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 12: Predose | -2.2 mmHg | Standard Deviation 11.7 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 12: 1 H Postdose | 0.4 mmHg | Standard Deviation 11.64 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 13: Predose | -0.2 mmHg | Standard Deviation 13.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 13: 1 H Postdose | 2.3 mmHg | Standard Deviation 13.27 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 14: Predose | -2.7 mmHg | Standard Deviation 14.09 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 14: 1 H Postdose | 0.1 mmHg | Standard Deviation 14.54 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 15/ET | 0.0 mmHg | Standard Deviation 14.14 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Follow-up Day 21 | 2.4 mmHg | Standard Deviation 13.92 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Follow-up Day 28 | 1.0 mmHg | Standard Deviation 13.83 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Follow-up Day 35 | 2.9 mmHg | Standard Deviation 15.58 |
| Part A: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Follow-up Day 42 | -0.9 mmHg | Standard Deviation 15.02 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 6: Predose | 5.3 mmHg | Standard Deviation 13.08 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | Baseline | 120.6 mmHg | Standard Deviation 13.95 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 13: 1 H Postdose | -0.2 mmHg | Standard Deviation 10.27 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 1: 0.25 H Postdose | 0.6 mmHg | Standard Deviation 9.57 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 6: 0.25 H Postdose | 6.3 mmHg | Standard Deviation 10.66 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 1: 0.5 H Postdose | 0.7 mmHg | Standard Deviation 10.38 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 10: Predose | -0.2 mmHg | Standard Deviation 12.08 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 1: 1 H Postdose | -0.3 mmHg | Standard Deviation 11.09 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 6: 0.5 H Postdose | 4.3 mmHg | Standard Deviation 12.23 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 1: 2 H Postdose | -0.5 mmHg | Standard Deviation 11.92 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Follow-up Day 21 | 6.2 mmHg | Standard Deviation 14.18 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 1: 12 H Postdose | -1.5 mmHg | Standard Deviation 10.58 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 6: 1 H Postdose | 4.7 mmHg | Standard Deviation 12.07 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 2: Predose | -0.9 mmHg | Standard Deviation 10.72 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 10: 1 H Postdose | 0.2 mmHg | Standard Deviation 11.39 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 2: 0.25 H Postdose | 0.9 mmHg | Standard Deviation 12.39 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 6: 2 H Postdose | 3.9 mmHg | Standard Deviation 14.18 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 2: 0.5 H Postdose | 0.2 mmHg | Standard Deviation 13.18 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 2: 1 H Postdose | -0.5 mmHg | Standard Deviation 11.19 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 14: Predose | 2.4 mmHg | Standard Deviation 12.12 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 6: 12 H Postdose | -0.2 mmHg | Standard Deviation 12.9 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 2: 2 H Postdose | -0.2 mmHg | Standard Deviation 12.39 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 11: Predose | 4.4 mmHg | Standard Deviation 13.67 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 2: 12 H Postdose | -1.4 mmHg | Standard Deviation 12.55 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 7: Predose | 3.2 mmHg | Standard Deviation 11.76 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 3: Predose | -0.1 mmHg | Standard Deviation 12.61 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Follow-up Day 35 | 7.8 mmHg | Standard Deviation 13.89 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 3: 0.25 H Postdose | 0.4 mmHg | Standard Deviation 12.37 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 7: 0.25 H Postdose | 1.8 mmHg | Standard Deviation 10.44 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 3: 0.5 H Postdose | -0.9 mmHg | Standard Deviation 13.55 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 11: 1 H Postdose | 3.1 mmHg | Standard Deviation 13 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 3: 1 H Postdose | -0.3 mmHg | Standard Deviation 12.76 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 7: 0.5 H Postdose | 2.4 mmHg | Standard Deviation 11.22 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 3: 2 H Postdose | -0.2 mmHg | Standard Deviation 14.21 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 14: 1 H Postdose | 2.9 mmHg | Standard Deviation 12.28 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 3: 12 H Postdose | -3.9 mmHg | Standard Deviation 12.84 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 7: 1 H Postdose | 3.0 mmHg | Standard Deviation 11.35 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 4: Predose | 0.6 mmHg | Standard Deviation 12.38 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 12: Predose | 1.7 mmHg | Standard Deviation 12.05 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 4: 0.25 H Postdose | 2.8 mmHg | Standard Deviation 11.28 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 7: 2 H Postdose | 0.8 mmHg | Standard Deviation 12.29 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 4: 0.5 H Postdose | 0.7 mmHg | Standard Deviation 10.42 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Follow-up Day 28 | 5.5 mmHg | Standard Deviation 11.63 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 4: 1 H Postdose | 0.4 mmHg | Standard Deviation 11.41 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 7: 12 H Postdose | 0.5 mmHg | Standard Deviation 12.11 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 4: 2 H Postdose | 0.3 mmHg | Standard Deviation 12.84 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 12: 1 H Postdose | 2.0 mmHg | Standard Deviation 12.33 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 4: 12 H Postdose | -0.1 mmHg | Standard Deviation 14.51 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 8: Predose | 2.3 mmHg | Standard Deviation 12.96 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 5: Predose | 1.0 mmHg | Standard Deviation 13.67 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 15/ET | 5.8 mmHg | Standard Deviation 12.1 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 5: 0.25 H Postdose | 2.6 mmHg | Standard Deviation 11.6 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 8: 1 H Postdose | 1.6 mmHg | Standard Deviation 14.27 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 5: 0.5 H Postdose | 1.2 mmHg | Standard Deviation 9.26 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 13: Predose | 1.4 mmHg | Standard Deviation 11.04 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 5: 1 H Postdose | 2.3 mmHg | Standard Deviation 11.04 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 9: Predose | 1.7 mmHg | Standard Deviation 11.76 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 5: 2 H Postdose | -2.4 mmHg | Standard Deviation 10.78 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Follow-up Day 42 | 8.3 mmHg | Standard Deviation 13.06 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 5: 12 H Postdose | -1.8 mmHg | Standard Deviation 12.13 |
| Part B: SAGE-217 | Change From Baseline (CFB) in Supine Systolic Blood Pressure - Part B | CFB at Day 9: 1 H Postdose | -0.1 mmHg | Standard Deviation 14.04 |
Secondary
Change From Baseline (CFB) in the SSS Score - Part B
The SSS was participant-rated scale designed to quickly assess how alert a participant was feeling. Degrees of sleepiness and alertness were rated on a scale of one to seven, where the lowest score of 'one' indicated the participant was 'feeling active, vital, alert, or wide awake' and the highest score of 'seven' indicated the participant was 'no longer fighting sleep, sleep onset soon; having dream-like thoughts'. A negative change from baseline indicated less sleepiness. A positive change from baseline indicated more sleepiness. The analysis was performed in participants included in Part B of the study. H = Hour(s).
Time frame: Baseline, Day 1 (0.25, 0.5, 1, 2 hours postdose), Days 2, 3, 4, 5, 6 and 7 (predose, 0.25, 0.5, 1, 2 hours postdose), Days 8, 9, 10, 11, 12, 13 and 14 (predose, 1 hour postdose), Day 15
Population: The safety set included all participants who received at least 1 dose of the double-blind study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 3: 0.5 H Postdose | -0.5 score on a scale | Standard Deviation 1.05 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 1: 0.25 H Postdose | 0.0 score on a scale | Standard Deviation 0.94 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 1: 0.5 H Postdose | -0.1 score on a scale | Standard Deviation 0.73 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 1: 1 H Postdose | -0.1 score on a scale | Standard Deviation 0.84 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 1: 2 H Postdose | -0.1 score on a scale | Standard Deviation 1.26 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 2: Predose | -0.6 score on a scale | Standard Deviation 1.19 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 2: 0.25 H Postdose | -0.5 score on a scale | Standard Deviation 1.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 2: 0.5 H Postdose | -0.5 score on a scale | Standard Deviation 1.13 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 2: 1 H Postdose | -0.3 score on a scale | Standard Deviation 1.06 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 2: 2 H Postdose | 0.1 score on a scale | Standard Deviation 1.29 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 3: Predose | -0.6 score on a scale | Standard Deviation 1.14 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 3: 0.25 H Postdose | -0.7 score on a scale | Standard Deviation 1.2 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | Baseline | 2.7 score on a scale | Standard Deviation 1.47 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 3: 1 H Postdose | -0.3 score on a scale | Standard Deviation 1.06 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 3: 2 H Postdose | 0.0 score on a scale | Standard Deviation 1.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 4: Predose | -0.7 score on a scale | Standard Deviation 1.22 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 4: 0.25 H Postdose | -0.7 score on a scale | Standard Deviation 1.16 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 4: 0.5 H Postdose | -0.5 score on a scale | Standard Deviation 1.19 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 4: 1 H Postdose | -0.4 score on a scale | Standard Deviation 1.19 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 4: 2 H Postdose | -0.3 score on a scale | Standard Deviation 1.21 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 5: Predose | -1.0 score on a scale | Standard Deviation 1.49 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 5: 0.25 H Postdose | -0.8 score on a scale | Standard Deviation 1.41 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 5: 0.5 H Postdose | -0.8 score on a scale | Standard Deviation 1.31 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 5: 1 H Postdose | -0.6 score on a scale | Standard Deviation 1.35 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 5: 2 H Postdose | -0.3 score on a scale | Standard Deviation 1.37 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 6: Predose | -0.8 score on a scale | Standard Deviation 1.15 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 6: 0.25 H Postdose | -0.7 score on a scale | Standard Deviation 1.2 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 6: 0.5 H Postdose | -0.6 score on a scale | Standard Deviation 1.18 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 6: 1 H Postdose | -0.4 score on a scale | Standard Deviation 1.03 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 6: 2 H Postdose | -0.2 score on a scale | Standard Deviation 1.17 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 7: Predose | -0.8 score on a scale | Standard Deviation 1.26 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 7: 0.25 H Postdose | -0.8 score on a scale | Standard Deviation 1.25 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 7: 0.5 H Postdose | -0.6 score on a scale | Standard Deviation 1.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 7: 1 H Postdose | -0.4 score on a scale | Standard Deviation 1.25 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 7: 2 H Postdose | -0.2 score on a scale | Standard Deviation 1.25 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 8: Predose | -0.8 score on a scale | Standard Deviation 1.34 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 8: 1 H Postdose | -0.6 score on a scale | Standard Deviation 1.38 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 9: Predose | -0.9 score on a scale | Standard Deviation 1.38 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 9: 1 H Postdose | -0.6 score on a scale | Standard Deviation 1.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 10: Predose | -1.0 score on a scale | Standard Deviation 1.32 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 10: 1 H Postdose | -0.7 score on a scale | Standard Deviation 1.28 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 11: Predose | -0.7 score on a scale | Standard Deviation 1.23 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 11: 1 H Postdose | -0.6 score on a scale | Standard Deviation 1.31 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 12: Predose | -0.9 score on a scale | Standard Deviation 1.25 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 12: 1 H Postdose | -0.7 score on a scale | Standard Deviation 1.3 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 13: Predose | -0.8 score on a scale | Standard Deviation 1.3 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 13: 1 H Postdose | -0.6 score on a scale | Standard Deviation 1.34 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 14: Predose | -0.7 score on a scale | Standard Deviation 1.27 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 14: 1 H Postdose | -0.5 score on a scale | Standard Deviation 1.31 |
| Part A: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 15 | -0.6 score on a scale | Standard Deviation 1.5 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 9: Predose | -0.6 score on a scale | Standard Deviation 1.35 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | Baseline | 2.6 score on a scale | Standard Deviation 1.31 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 6: Predose | -0.5 score on a scale | Standard Deviation 1.39 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 1: 0.25 H Postdose | 0.0 score on a scale | Standard Deviation 0.82 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 14: 1 H Postdose | -0.3 score on a scale | Standard Deviation 1.46 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 1: 0.5 H Postdose | 0.0 score on a scale | Standard Deviation 1.2 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 6: 0.25 H Postdose | -0.2 score on a scale | Standard Deviation 1.4 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 1: 1 H Postdose | 0.2 score on a scale | Standard Deviation 1.54 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 9: 1 H Postdose | -0.3 score on a scale | Standard Deviation 1.42 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 1: 2 H Postdose | 0.6 score on a scale | Standard Deviation 1.7 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 6: 0.5 H Postdose | -0.2 score on a scale | Standard Deviation 1.39 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 2: Predose | -0.1 score on a scale | Standard Deviation 1.39 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 12: 1 H Postdose | -0.4 score on a scale | Standard Deviation 1.76 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 2: 0.25 H Postdose | 0.1 score on a scale | Standard Deviation 1.59 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 6: 1 H Postdose | 0.1 score on a scale | Standard Deviation 1.45 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 2: 0.5 H Postdose | 0.2 score on a scale | Standard Deviation 1.62 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 10: Predose | -0.6 score on a scale | Standard Deviation 1.38 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 2: 1 H Postdose | 0.5 score on a scale | Standard Deviation 1.75 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 6: 2 H Postdose | 0.2 score on a scale | Standard Deviation 1.49 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 2: 2 H Postdose | 0.4 score on a scale | Standard Deviation 1.73 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 14: Predose | -0.7 score on a scale | Standard Deviation 1.35 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 3: Predose | -0.4 score on a scale | Standard Deviation 1.11 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 7: Predose | -0.6 score on a scale | Standard Deviation 1.31 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 3: 0.25 H Postdose | -0.2 score on a scale | Standard Deviation 1.45 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 10: 1 H Postdose | -0.3 score on a scale | Standard Deviation 1.55 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 3: 0.5 H Postdose | -0.1 score on a scale | Standard Deviation 1.5 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 7: 0.25 H Postdose | -0.5 score on a scale | Standard Deviation 1.47 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 3: 1 H Postdose | 0.1 score on a scale | Standard Deviation 1.55 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 13: Predose | -0.8 score on a scale | Standard Deviation 1.5 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 3: 2 H Postdose | 0.5 score on a scale | Standard Deviation 1.53 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 7: 0.5 H Postdose | -0.3 score on a scale | Standard Deviation 1.3 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 4: Predose | -0.3 score on a scale | Standard Deviation 1.39 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 11: Predose | -0.6 score on a scale | Standard Deviation 1.36 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 4: 0.25 H Postdose | -0.2 score on a scale | Standard Deviation 1.37 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 7: 1 H Postdose | -0.2 score on a scale | Standard Deviation 1.36 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 4: 0.5 H Postdose | 0.0 score on a scale | Standard Deviation 1.42 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 15 | -0.8 score on a scale | Standard Deviation 1.61 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 4: 1 H Postdose | 0.0 score on a scale | Standard Deviation 1.44 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 7: 2 H Postdose | 0.1 score on a scale | Standard Deviation 1.4 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 4: 2 H Postdose | 0.4 score on a scale | Standard Deviation 1.53 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 11: 1 H Postdose | -0.3 score on a scale | Standard Deviation 1.68 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 5: Predose | -0.5 score on a scale | Standard Deviation 1.32 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 8: Predose | -0.7 score on a scale | Standard Deviation 1.36 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 5: 0.25 H Postdose | -0.3 score on a scale | Standard Deviation 1.44 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 13: 1 H Postdose | -0.4 score on a scale | Standard Deviation 1.5 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 5: 0.5 H Postdose | -0.2 score on a scale | Standard Deviation 1.29 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 8: 1 H Postdose | -0.2 score on a scale | Standard Deviation 1.65 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 5: 1 H Postdose | 0.2 score on a scale | Standard Deviation 1.5 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 12: Predose | -0.7 score on a scale | Standard Deviation 1.44 |
| Part B: SAGE-217 | Change From Baseline (CFB) in the SSS Score - Part B | CFB at Day 5: 2 H Postdose | 0.4 score on a scale | Standard Deviation 1.49 |
Secondary
Change From Baseline in Activated Partial Thromboplastin Time - Part B
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part B | Change from Baseline at Day 15/ET | 0.10 sec |
| Part A: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part B | Change from Baseline at Follow-up Day 28 | 0.40 sec |
| Part A: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part B | Change from Baseline at Day 8 | 0.20 sec |
| Part A: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part B | Change from Baseline at Follow-up Day 35 | 0.10 sec |
| Part A: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part B | Change from Baseline at Follow-up Day 21 | 0.40 sec |
| Part A: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part B | Change from Baseline at Follow-up Day 42 | 0.30 sec |
| Part A: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part B | Baseline | 27.60 sec |
| Part B: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part B | Change from Baseline at Follow-up Day 42 | 0.20 sec |
| Part B: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part B | Baseline | 27.80 sec |
| Part B: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part B | Change from Baseline at Day 8 | -0.20 sec |
| Part B: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part B | Change from Baseline at Day 15/ET | 0.40 sec |
| Part B: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part B | Change from Baseline at Follow-up Day 21 | 0.05 sec |
| Part B: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part B | Change from Baseline at Follow-up Day 28 | 0.30 sec |
| Part B: SAGE-217 | Change From Baseline in Activated Partial Thromboplastin Time - Part B | Change from Baseline at Follow-up Day 35 | -0.25 sec |
Secondary
Change From Baseline in Alanine Aminotransferase - Part B
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part B | Change from Baseline at Day 15/ET | 7.3 U/L | Standard Deviation 22.23 |
| Part A: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part B | Change from Baseline at Follow-up Day 28 | 1.6 U/L | Standard Deviation 9.57 |
| Part A: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part B | Change from Baseline at Day 8 | 4.1 U/L | Standard Deviation 13.09 |
| Part A: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part B | Change from Baseline at Follow-up Day 35 | 0.5 U/L | Standard Deviation 8.55 |
| Part A: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part B | Change from Baseline at Follow-up Day 21 | 3.4 U/L | Standard Deviation 22.86 |
| Part A: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part B | Change from Baseline at Follow-up Day 42 | -0.2 U/L | Standard Deviation 10.12 |
| Part A: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part B | Baseline | 22.9 U/L | Standard Deviation 11.09 |
| Part B: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part B | Change from Baseline at Follow-up Day 42 | -1.0 U/L | Standard Deviation 6.3 |
| Part B: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part B | Baseline | 22.2 U/L | Standard Deviation 9.43 |
| Part B: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part B | Change from Baseline at Day 8 | 11.0 U/L | Standard Deviation 28.79 |
| Part B: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part B | Change from Baseline at Day 15/ET | 9.1 U/L | Standard Deviation 32.27 |
| Part B: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part B | Change from Baseline at Follow-up Day 21 | 0.1 U/L | Standard Deviation 6.5 |
| Part B: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part B | Change from Baseline at Follow-up Day 28 | -0.8 U/L | Standard Deviation 6.21 |
| Part B: SAGE-217 | Change From Baseline in Alanine Aminotransferase - Part B | Change from Baseline at Follow-up Day 35 | 0.5 U/L | Standard Deviation 10.11 |
Secondary
Change From Baseline in Albumin - Part B
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Albumin - Part B | Change from Baseline at Day 15/ET | -0.8 g/L | Standard Deviation 2.73 |
| Part A: SAGE-217 | Change From Baseline in Albumin - Part B | Change from Baseline at Follow-up Day 28 | -0.2 g/L | Standard Deviation 3.01 |
| Part A: SAGE-217 | Change From Baseline in Albumin - Part B | Change from Baseline at Day 8 | -1.1 g/L | Standard Deviation 2.66 |
| Part A: SAGE-217 | Change From Baseline in Albumin - Part B | Change from Baseline at Follow-up Day 35 | -0.5 g/L | Standard Deviation 2.9 |
| Part A: SAGE-217 | Change From Baseline in Albumin - Part B | Change from Baseline at Follow-up Day 21 | -1.1 g/L | Standard Deviation 2.72 |
| Part A: SAGE-217 | Change From Baseline in Albumin - Part B | Change from Baseline at Follow-up Day 42 | -0.5 g/L | Standard Deviation 2.3 |
| Part A: SAGE-217 | Change From Baseline in Albumin - Part B | Baseline | 44.6 g/L | Standard Deviation 2.69 |
| Part B: SAGE-217 | Change From Baseline in Albumin - Part B | Change from Baseline at Follow-up Day 42 | -0.7 g/L | Standard Deviation 3.43 |
| Part B: SAGE-217 | Change From Baseline in Albumin - Part B | Baseline | 44.6 g/L | Standard Deviation 3.3 |
| Part B: SAGE-217 | Change From Baseline in Albumin - Part B | Change from Baseline at Day 8 | -0.8 g/L | Standard Deviation 3.24 |
| Part B: SAGE-217 | Change From Baseline in Albumin - Part B | Change from Baseline at Day 15/ET | -0.9 g/L | Standard Deviation 3.23 |
| Part B: SAGE-217 | Change From Baseline in Albumin - Part B | Change from Baseline at Follow-up Day 21 | -1.4 g/L | Standard Deviation 3.4 |
| Part B: SAGE-217 | Change From Baseline in Albumin - Part B | Change from Baseline at Follow-up Day 28 | -0.9 g/L | Standard Deviation 3.07 |
| Part B: SAGE-217 | Change From Baseline in Albumin - Part B | Change from Baseline at Follow-up Day 35 | -1.0 g/L | Standard Deviation 3.4 |
Secondary
Change From Baseline in Alkaline Phosphatase - Part B
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part B | Change from Baseline at Day 15/ET | 1.6 U/L | Standard Deviation 10.39 |
| Part A: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part B | Change from Baseline at Follow-up Day 28 | -0.8 U/L | Standard Deviation 8.5 |
| Part A: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part B | Change from Baseline at Day 8 | -0.1 U/L | Standard Deviation 8.95 |
| Part A: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part B | Change from Baseline at Follow-up Day 35 | 1.0 U/L | Standard Deviation 8.28 |
| Part A: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part B | Change from Baseline at Follow-up Day 21 | -0.9 U/L | Standard Deviation 7.66 |
| Part A: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part B | Change from Baseline at Follow-up Day 42 | -0.4 U/L | Standard Deviation 12.97 |
| Part A: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part B | Baseline | 80.9 U/L | Standard Deviation 19.18 |
| Part B: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part B | Change from Baseline at Follow-up Day 42 | -4.4 U/L | Standard Deviation 9.26 |
| Part B: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part B | Baseline | 85.5 U/L | Standard Deviation 27.97 |
| Part B: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part B | Change from Baseline at Day 8 | 1.3 U/L | Standard Deviation 14.37 |
| Part B: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part B | Change from Baseline at Day 15/ET | 3.1 U/L | Standard Deviation 17.84 |
| Part B: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part B | Change from Baseline at Follow-up Day 21 | -2.9 U/L | Standard Deviation 13.64 |
| Part B: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part B | Change from Baseline at Follow-up Day 28 | -2.5 U/L | Standard Deviation 11.01 |
| Part B: SAGE-217 | Change From Baseline in Alkaline Phosphatase - Part B | Change from Baseline at Follow-up Day 35 | -4.3 U/L | Standard Deviation 8.87 |
Secondary
Change From Baseline in Aspartate Aminotransferase - Part B
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part B | Change from Baseline at Day 15/ET | 2.2 U/L | Standard Deviation 12.54 |
| Part A: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part B | Change from Baseline at Follow-up Day 28 | -0.5 U/L | Standard Deviation 4.89 |
| Part A: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part B | Change from Baseline at Day 8 | -0.5 U/L | Standard Deviation 6.31 |
| Part A: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part B | Change from Baseline at Follow-up Day 35 | -1.2 U/L | Standard Deviation 5.43 |
| Part A: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part B | Change from Baseline at Follow-up Day 21 | 1.4 U/L | Standard Deviation 11.6 |
| Part A: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part B | Change from Baseline at Follow-up Day 42 | 0.1 U/L | Standard Deviation 7.03 |
| Part A: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part B | Baseline | 23.0 U/L | Standard Deviation 5.19 |
| Part B: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part B | Change from Baseline at Follow-up Day 42 | -0.1 U/L | Standard Deviation 6.4 |
| Part B: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part B | Baseline | 23.5 U/L | Standard Deviation 6.49 |
| Part B: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part B | Change from Baseline at Day 8 | 10.0 U/L | Standard Deviation 43.42 |
| Part B: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part B | Change from Baseline at Day 15/ET | 5.0 U/L | Standard Deviation 27.21 |
| Part B: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part B | Change from Baseline at Follow-up Day 21 | -0.1 U/L | Standard Deviation 6.79 |
| Part B: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part B | Change from Baseline at Follow-up Day 28 | -0.3 U/L | Standard Deviation 7.62 |
| Part B: SAGE-217 | Change From Baseline in Aspartate Aminotransferase - Part B | Change from Baseline at Follow-up Day 35 | -0.5 U/L | Standard Deviation 7.36 |
Secondary
Change From Baseline in Basophils - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Basophils - Part B | Change from Baseline at Day 15/ET | 0.005 10^9 cells/L | Standard Deviation 0.0486 |
| Part A: SAGE-217 | Change From Baseline in Basophils - Part B | Change from Baseline at Follow-up Day 28 | 0.008 10^9 cells/L | Standard Deviation 0.0497 |
| Part A: SAGE-217 | Change From Baseline in Basophils - Part B | Change from Baseline at Day 8 | 0.012 10^9 cells/L | Standard Deviation 0.0495 |
| Part A: SAGE-217 | Change From Baseline in Basophils - Part B | Change from Baseline at Follow-up Day 35 | 0.008 10^9 cells/L | Standard Deviation 0.0561 |
| Part A: SAGE-217 | Change From Baseline in Basophils - Part B | Change from Baseline at Follow-up Day 21 | 0.000 10^9 cells/L | Standard Deviation 0.0484 |
| Part A: SAGE-217 | Change From Baseline in Basophils - Part B | Change from Baseline at Follow-up Day 42 | 0.011 10^9 cells/L | Standard Deviation 0.0483 |
| Part A: SAGE-217 | Change From Baseline in Basophils - Part B | Baseline | 0.038 10^9 cells/L | Standard Deviation 0.0478 |
| Part B: SAGE-217 | Change From Baseline in Basophils - Part B | Change from Baseline at Follow-up Day 42 | -0.006 10^9 cells/L | Standard Deviation 0.0494 |
| Part B: SAGE-217 | Change From Baseline in Basophils - Part B | Baseline | 0.041 10^9 cells/L | Standard Deviation 0.0489 |
| Part B: SAGE-217 | Change From Baseline in Basophils - Part B | Change from Baseline at Day 8 | -0.004 10^9 cells/L | Standard Deviation 0.052 |
| Part B: SAGE-217 | Change From Baseline in Basophils - Part B | Change from Baseline at Day 15/ET | 0.001 10^9 cells/L | Standard Deviation 0.0359 |
| Part B: SAGE-217 | Change From Baseline in Basophils - Part B | Change from Baseline at Follow-up Day 21 | -0.013 10^9 cells/L | Standard Deviation 0.0396 |
| Part B: SAGE-217 | Change From Baseline in Basophils - Part B | Change from Baseline at Follow-up Day 28 | -0.018 10^9 cells/L | Standard Deviation 0.0436 |
| Part B: SAGE-217 | Change From Baseline in Basophils - Part B | Change from Baseline at Follow-up Day 35 | 0.007 10^9 cells/L | Standard Deviation 0.0352 |
Secondary
Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 15/ET | 0.05 percentage | Standard Deviation 0.174 |
| Part A: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 28 | 0.05 percentage | Standard Deviation 0.258 |
| Part A: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 8 | 0.11 percentage | Standard Deviation 0.241 |
| Part A: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 35 | 0.04 percentage | Standard Deviation 0.265 |
| Part A: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 21 | 0.06 percentage | Standard Deviation 0.227 |
| Part A: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 42 | 0.10 percentage | Standard Deviation 0.24 |
| Part A: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B | Baseline | 0.63 percentage | Standard Deviation 0.302 |
| Part B: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 42 | 0.07 percentage | Standard Deviation 0.255 |
| Part B: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B | Baseline | 0.63 percentage | Standard Deviation 0.274 |
| Part B: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 8 | 0.04 percentage | Standard Deviation 0.229 |
| Part B: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 15/ET | 0.11 percentage | Standard Deviation 0.231 |
| Part B: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 21 | 0.02 percentage | Standard Deviation 0.24 |
| Part B: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 28 | -0.01 percentage | Standard Deviation 0.318 |
| Part B: SAGE-217 | Change From Baseline in Basophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 35 | 0.10 percentage | Standard Deviation 0.18 |
Secondary
Change From Baseline in Bilirubin - Part B
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Bilirubin - Part B | Change from Baseline at Day 15/ET | -0.652 umol/L | Standard Deviation 3.3092 |
| Part A: SAGE-217 | Change From Baseline in Bilirubin - Part B | Change from Baseline at Follow-up Day 28 | -1.049 umol/L | Standard Deviation 3.0737 |
| Part A: SAGE-217 | Change From Baseline in Bilirubin - Part B | Change from Baseline at Day 8 | -1.095 umol/L | Standard Deviation 2.783 |
| Part A: SAGE-217 | Change From Baseline in Bilirubin - Part B | Change from Baseline at Follow-up Day 35 | -0.945 umol/L | Standard Deviation 3.647 |
| Part A: SAGE-217 | Change From Baseline in Bilirubin - Part B | Change from Baseline at Follow-up Day 21 | -0.453 umol/L | Standard Deviation 3.747 |
| Part A: SAGE-217 | Change From Baseline in Bilirubin - Part B | Change from Baseline at Follow-up Day 42 | -0.708 umol/L | Standard Deviation 3.9947 |
| Part A: SAGE-217 | Change From Baseline in Bilirubin - Part B | Baseline | 8.157 umol/L | Standard Deviation 3.516 |
| Part B: SAGE-217 | Change From Baseline in Bilirubin - Part B | Change from Baseline at Follow-up Day 42 | -0.526 umol/L | Standard Deviation 4.445 |
| Part B: SAGE-217 | Change From Baseline in Bilirubin - Part B | Baseline | 9.422 umol/L | Standard Deviation 7.5457 |
| Part B: SAGE-217 | Change From Baseline in Bilirubin - Part B | Change from Baseline at Day 8 | -1.670 umol/L | Standard Deviation 4.7335 |
| Part B: SAGE-217 | Change From Baseline in Bilirubin - Part B | Change from Baseline at Day 15/ET | -1.673 umol/L | Standard Deviation 3.1661 |
| Part B: SAGE-217 | Change From Baseline in Bilirubin - Part B | Change from Baseline at Follow-up Day 21 | -0.978 umol/L | Standard Deviation 3.0372 |
| Part B: SAGE-217 | Change From Baseline in Bilirubin - Part B | Change from Baseline at Follow-up Day 28 | 0.162 umol/L | Standard Deviation 3.7768 |
| Part B: SAGE-217 | Change From Baseline in Bilirubin - Part B | Change from Baseline at Follow-up Day 35 | -1.170 umol/L | Standard Deviation 4.3101 |
Secondary
Change From Baseline in Calcium - Part B
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Calcium - Part B | Change from Baseline at Day 15/ET | -0.019 mmol/L | Standard Deviation 0.1083 |
| Part A: SAGE-217 | Change From Baseline in Calcium - Part B | Change from Baseline at Follow-up Day 28 | -0.035 mmol/L | Standard Deviation 0.1138 |
| Part A: SAGE-217 | Change From Baseline in Calcium - Part B | Change from Baseline at Day 8 | -0.021 mmol/L | Standard Deviation 0.0911 |
| Part A: SAGE-217 | Change From Baseline in Calcium - Part B | Change from Baseline at Follow-up Day 35 | -0.038 mmol/L | Standard Deviation 0.1024 |
| Part A: SAGE-217 | Change From Baseline in Calcium - Part B | Change from Baseline at Follow-up Day 21 | -0.038 mmol/L | Standard Deviation 0.09 |
| Part A: SAGE-217 | Change From Baseline in Calcium - Part B | Change from Baseline at Follow-up Day 42 | -0.041 mmol/L | Standard Deviation 0.0954 |
| Part A: SAGE-217 | Change From Baseline in Calcium - Part B | Baseline | 2.359 mmol/L | Standard Deviation 0.0909 |
| Part B: SAGE-217 | Change From Baseline in Calcium - Part B | Change from Baseline at Follow-up Day 42 | -0.041 mmol/L | Standard Deviation 0.129 |
| Part B: SAGE-217 | Change From Baseline in Calcium - Part B | Baseline | 2.364 mmol/L | Standard Deviation 0.1517 |
| Part B: SAGE-217 | Change From Baseline in Calcium - Part B | Change from Baseline at Day 8 | -0.033 mmol/L | Standard Deviation 0.122 |
| Part B: SAGE-217 | Change From Baseline in Calcium - Part B | Change from Baseline at Day 15/ET | -0.041 mmol/L | Standard Deviation 0.1171 |
| Part B: SAGE-217 | Change From Baseline in Calcium - Part B | Change from Baseline at Follow-up Day 21 | -0.065 mmol/L | Standard Deviation 0.112 |
| Part B: SAGE-217 | Change From Baseline in Calcium - Part B | Change from Baseline at Follow-up Day 28 | -0.044 mmol/L | Standard Deviation 0.0961 |
| Part B: SAGE-217 | Change From Baseline in Calcium - Part B | Change from Baseline at Follow-up Day 35 | -0.048 mmol/L | Standard Deviation 0.1201 |
Secondary
Change From Baseline in Carbon Dioxide - Part B
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Carbon Dioxide - Part B | Change from Baseline at Day 15/ET | -0.3 mmol/L | Standard Deviation 2.41 |
| Part A: SAGE-217 | Change From Baseline in Carbon Dioxide - Part B | Change from Baseline at Follow-up Day 28 | -1.0 mmol/L | Standard Deviation 2.84 |
| Part A: SAGE-217 | Change From Baseline in Carbon Dioxide - Part B | Change from Baseline at Day 8 | -1.1 mmol/L | Standard Deviation 2.87 |
| Part A: SAGE-217 | Change From Baseline in Carbon Dioxide - Part B | Change from Baseline at Follow-up Day 35 | -1.0 mmol/L | Standard Deviation 2.56 |
| Part A: SAGE-217 | Change From Baseline in Carbon Dioxide - Part B | Change from Baseline at Follow-up Day 21 | -1.1 mmol/L | Standard Deviation 2.31 |
| Part A: SAGE-217 | Change From Baseline in Carbon Dioxide - Part B | Change from Baseline at Follow-up Day 42 | -0.8 mmol/L | Standard Deviation 2.86 |
| Part A: SAGE-217 | Change From Baseline in Carbon Dioxide - Part B | Baseline | 29.3 mmol/L | Standard Deviation 2.32 |
| Part B: SAGE-217 | Change From Baseline in Carbon Dioxide - Part B | Change from Baseline at Follow-up Day 42 | -0.8 mmol/L | Standard Deviation 2.7 |
| Part B: SAGE-217 | Change From Baseline in Carbon Dioxide - Part B | Baseline | 28.8 mmol/L | Standard Deviation 2.25 |
| Part B: SAGE-217 | Change From Baseline in Carbon Dioxide - Part B | Change from Baseline at Day 8 | 0.0 mmol/L | Standard Deviation 2.61 |
| Part B: SAGE-217 | Change From Baseline in Carbon Dioxide - Part B | Change from Baseline at Day 15/ET | 0.7 mmol/L | Standard Deviation 2.32 |
| Part B: SAGE-217 | Change From Baseline in Carbon Dioxide - Part B | Change from Baseline at Follow-up Day 21 | 0.2 mmol/L | Standard Deviation 2.5 |
| Part B: SAGE-217 | Change From Baseline in Carbon Dioxide - Part B | Change from Baseline at Follow-up Day 28 | -0.5 mmol/L | Standard Deviation 2.69 |
| Part B: SAGE-217 | Change From Baseline in Carbon Dioxide - Part B | Change from Baseline at Follow-up Day 35 | -0.1 mmol/L | Standard Deviation 2.68 |
Secondary
Change From Baseline in Chloride - Part B
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Chloride - Part B | Change from Baseline at Day 8 | -0.2 mmol/L | Standard Deviation 2.49 |
| Part A: SAGE-217 | Change From Baseline in Chloride - Part B | Change from Baseline at Follow-up Day 28 | 0.6 mmol/L | Standard Deviation 2.47 |
| Part A: SAGE-217 | Change From Baseline in Chloride - Part B | Change from Baseline at Day 15/ET | -0.4 mmol/L | Standard Deviation 2.1 |
| Part A: SAGE-217 | Change From Baseline in Chloride - Part B | Change from Baseline at Follow-up Day 35 | 0.0 mmol/L | Standard Deviation 2.5 |
| Part A: SAGE-217 | Change From Baseline in Chloride - Part B | Baseline | 104.7 mmol/L | Standard Deviation 1.87 |
| Part A: SAGE-217 | Change From Baseline in Chloride - Part B | Change from Baseline at Follow-up Day 42 | 0.4 mmol/L | Standard Deviation 2.39 |
| Part A: SAGE-217 | Change From Baseline in Chloride - Part B | Change from Baseline at Follow-up Day 21 | 0.8 mmol/L | Standard Deviation 2.59 |
| Part B: SAGE-217 | Change From Baseline in Chloride - Part B | Change from Baseline at Follow-up Day 42 | 0.8 mmol/L | Standard Deviation 2.75 |
| Part B: SAGE-217 | Change From Baseline in Chloride - Part B | Change from Baseline at Day 8 | -0.2 mmol/L | Standard Deviation 2.86 |
| Part B: SAGE-217 | Change From Baseline in Chloride - Part B | Change from Baseline at Day 15/ET | -0.1 mmol/L | Standard Deviation 2.83 |
| Part B: SAGE-217 | Change From Baseline in Chloride - Part B | Change from Baseline at Follow-up Day 21 | 0.5 mmol/L | Standard Deviation 2.37 |
| Part B: SAGE-217 | Change From Baseline in Chloride - Part B | Change from Baseline at Follow-up Day 28 | 0.3 mmol/L | Standard Deviation 3.27 |
| Part B: SAGE-217 | Change From Baseline in Chloride - Part B | Change from Baseline at Follow-up Day 35 | 1.1 mmol/L | Standard Deviation 2.49 |
| Part B: SAGE-217 | Change From Baseline in Chloride - Part B | Baseline | 104.4 mmol/L | Standard Deviation 2.53 |
Secondary
Change From Baseline in Creatinine - Part B
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Creatinine - Part B | Change from Baseline at Day 15/ET | 1.028 umol/L | Standard Deviation 9.1198 |
| Part A: SAGE-217 | Change From Baseline in Creatinine - Part B | Change from Baseline at Follow-up Day 28 | 4.462 umol/L | Standard Deviation 7.4979 |
| Part A: SAGE-217 | Change From Baseline in Creatinine - Part B | Change from Baseline at Day 8 | 0.036 umol/L | Standard Deviation 7.6537 |
| Part A: SAGE-217 | Change From Baseline in Creatinine - Part B | Change from Baseline at Follow-up Day 35 | 2.300 umol/L | Standard Deviation 9.0428 |
| Part A: SAGE-217 | Change From Baseline in Creatinine - Part B | Change from Baseline at Follow-up Day 21 | 0.632 umol/L | Standard Deviation 8.8186 |
| Part A: SAGE-217 | Change From Baseline in Creatinine - Part B | Change from Baseline at Follow-up Day 42 | 1.949 umol/L | Standard Deviation 8.5582 |
| Part A: SAGE-217 | Change From Baseline in Creatinine - Part B | Baseline | 76.363 umol/L | Standard Deviation 16.0294 |
| Part B: SAGE-217 | Change From Baseline in Creatinine - Part B | Change from Baseline at Follow-up Day 42 | 0.852 umol/L | Standard Deviation 9.5738 |
| Part B: SAGE-217 | Change From Baseline in Creatinine - Part B | Baseline | 77.894 umol/L | Standard Deviation 14.1946 |
| Part B: SAGE-217 | Change From Baseline in Creatinine - Part B | Change from Baseline at Day 8 | -1.710 umol/L | Standard Deviation 8.085 |
| Part B: SAGE-217 | Change From Baseline in Creatinine - Part B | Change from Baseline at Day 15/ET | 0.566 umol/L | Standard Deviation 7.9601 |
| Part B: SAGE-217 | Change From Baseline in Creatinine - Part B | Change from Baseline at Follow-up Day 21 | 1.495 umol/L | Standard Deviation 9.8651 |
| Part B: SAGE-217 | Change From Baseline in Creatinine - Part B | Change from Baseline at Follow-up Day 28 | 2.614 umol/L | Standard Deviation 6.6486 |
| Part B: SAGE-217 | Change From Baseline in Creatinine - Part B | Change from Baseline at Follow-up Day 35 | 1.263 umol/L | Standard Deviation 14.2508 |
Secondary
Change From Baseline in ECG Mean Heart Rate - Part B
ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study.
Time frame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part B | Baseline | 65.0 beats/min | Standard Deviation 11.17 |
| Part A: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part B | Change from Baseline at Day 1 | 3.2 beats/min | Standard Deviation 8.74 |
| Part A: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part B | Change from Baseline at Day 2 | 6.0 beats/min | Standard Deviation 9.58 |
| Part A: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part B | Change from Baseline at Day 7 | 8.3 beats/min | Standard Deviation 9.67 |
| Part A: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part B | Change from Baseline at Day 14 | 7.1 beats/min | Standard Deviation 9.22 |
| Part A: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part B | Change from Baseline at Follow-up Day 21 | 5.1 beats/min | Standard Deviation 9.22 |
| Part B: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part B | Change from Baseline at Day 14 | 11.0 beats/min | Standard Deviation 11.23 |
| Part B: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part B | Baseline | 64.8 beats/min | Standard Deviation 10.06 |
| Part B: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part B | Change from Baseline at Day 7 | 7.2 beats/min | Standard Deviation 10.37 |
| Part B: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part B | Change from Baseline at Day 1 | 4.5 beats/min | Standard Deviation 10.25 |
| Part B: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part B | Change from Baseline at Follow-up Day 21 | -0.5 beats/min | Standard Deviation 15.1 |
| Part B: SAGE-217 | Change From Baseline in ECG Mean Heart Rate - Part B | Change from Baseline at Day 2 | 4.7 beats/min | Standard Deviation 10.91 |
Secondary
Change From Baseline in Eosinophils - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Eosinophils - Part B | Change from Baseline at Day 15/ET | 0.027 10^9 cells/L | Standard Deviation 0.0804 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils - Part B | Change from Baseline at Follow-up Day 28 | 0.022 10^9 cells/L | Standard Deviation 0.094 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils - Part B | Change from Baseline at Day 8 | 0.004 10^9 cells/L | Standard Deviation 0.0578 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils - Part B | Change from Baseline at Follow-up Day 35 | 0.006 10^9 cells/L | Standard Deviation 0.0799 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils - Part B | Change from Baseline at Follow-up Day 21 | 0.020 10^9 cells/L | Standard Deviation 0.0789 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils - Part B | Change from Baseline at Follow-up Day 42 | 0.017 10^9 cells/L | Standard Deviation 0.0772 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils - Part B | Baseline | 0.147 10^9 cells/L | Standard Deviation 0.0818 |
| Part B: SAGE-217 | Change From Baseline in Eosinophils - Part B | Change from Baseline at Follow-up Day 42 | 0.017 10^9 cells/L | Standard Deviation 0.0735 |
| Part B: SAGE-217 | Change From Baseline in Eosinophils - Part B | Baseline | 0.126 10^9 cells/L | Standard Deviation 0.0801 |
| Part B: SAGE-217 | Change From Baseline in Eosinophils - Part B | Change from Baseline at Day 8 | 0.025 10^9 cells/L | Standard Deviation 0.0795 |
| Part B: SAGE-217 | Change From Baseline in Eosinophils - Part B | Change from Baseline at Day 15/ET | 0.037 10^9 cells/L | Standard Deviation 0.089 |
| Part B: SAGE-217 | Change From Baseline in Eosinophils - Part B | Change from Baseline at Follow-up Day 21 | 0.027 10^9 cells/L | Standard Deviation 0.0696 |
| Part B: SAGE-217 | Change From Baseline in Eosinophils - Part B | Change from Baseline at Follow-up Day 28 | 0.015 10^9 cells/L | Standard Deviation 0.0724 |
| Part B: SAGE-217 | Change From Baseline in Eosinophils - Part B | Change from Baseline at Follow-up Day 35 | 0.012 10^9 cells/L | Standard Deviation 0.076 |
Secondary
Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 15/ET | 0.53 percentage | Standard Deviation 1.042 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 28 | 0.48 percentage | Standard Deviation 1.221 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 8 | 0.15 percentage | Standard Deviation 0.78 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 35 | 0.42 percentage | Standard Deviation 0.996 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 21 | 0.48 percentage | Standard Deviation 1.08 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 42 | 0.55 percentage | Standard Deviation 1.089 |
| Part A: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B | Baseline | 1.95 percentage | Standard Deviation 1.018 |
| Part B: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 42 | 0.46 percentage | Standard Deviation 1.192 |
| Part B: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B | Baseline | 1.96 percentage | Standard Deviation 1.267 |
| Part B: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 8 | 0.44 percentage | Standard Deviation 1.102 |
| Part B: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 15/ET | 0.60 percentage | Standard Deviation 1.166 |
| Part B: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 21 | 0.53 percentage | Standard Deviation 0.916 |
| Part B: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 28 | 0.39 percentage | Standard Deviation 1.092 |
| Part B: SAGE-217 | Change From Baseline in Eosinophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 35 | 0.37 percentage | Standard Deviation 1.015 |
Secondary
Change From Baseline in Erythrocytes - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Erythrocytes - Part B | Change from Baseline at Day 15/ET | -0.069 10^12 cells/L | Standard Deviation 0.2436 |
| Part A: SAGE-217 | Change From Baseline in Erythrocytes - Part B | Change from Baseline at Follow-up Day 28 | -0.176 10^12 cells/L | Standard Deviation 0.2599 |
| Part A: SAGE-217 | Change From Baseline in Erythrocytes - Part B | Change from Baseline at Day 8 | -0.041 10^12 cells/L | Standard Deviation 0.2802 |
| Part A: SAGE-217 | Change From Baseline in Erythrocytes - Part B | Change from Baseline at Follow-up Day 35 | -0.134 10^12 cells/L | Standard Deviation 0.305 |
| Part A: SAGE-217 | Change From Baseline in Erythrocytes - Part B | Change from Baseline at Follow-up Day 21 | -0.182 10^12 cells/L | Standard Deviation 0.2841 |
| Part A: SAGE-217 | Change From Baseline in Erythrocytes - Part B | Change from Baseline at Follow-up Day 42 | -0.161 10^12 cells/L | Standard Deviation 0.2365 |
| Part A: SAGE-217 | Change From Baseline in Erythrocytes - Part B | Baseline | 4.811 10^12 cells/L | Standard Deviation 0.4827 |
| Part B: SAGE-217 | Change From Baseline in Erythrocytes - Part B | Change from Baseline at Follow-up Day 42 | -0.202 10^12 cells/L | Standard Deviation 0.3181 |
| Part B: SAGE-217 | Change From Baseline in Erythrocytes - Part B | Baseline | 4.902 10^12 cells/L | Standard Deviation 0.4956 |
| Part B: SAGE-217 | Change From Baseline in Erythrocytes - Part B | Change from Baseline at Day 8 | -0.074 10^12 cells/L | Standard Deviation 0.2889 |
| Part B: SAGE-217 | Change From Baseline in Erythrocytes - Part B | Change from Baseline at Day 15/ET | -0.128 10^12 cells/L | Standard Deviation 0.2714 |
| Part B: SAGE-217 | Change From Baseline in Erythrocytes - Part B | Change from Baseline at Follow-up Day 21 | -0.225 10^12 cells/L | Standard Deviation 0.2794 |
| Part B: SAGE-217 | Change From Baseline in Erythrocytes - Part B | Change from Baseline at Follow-up Day 28 | -0.172 10^12 cells/L | Standard Deviation 0.2684 |
| Part B: SAGE-217 | Change From Baseline in Erythrocytes - Part B | Change from Baseline at Follow-up Day 35 | -0.189 10^12 cells/L | Standard Deviation 0.2675 |
Secondary
Change From Baseline in Glucose - Part B
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Glucose - Part B | Change from Baseline at Day 15/ET | 0.203 mmol/L | Standard Deviation 1.5462 |
| Part A: SAGE-217 | Change From Baseline in Glucose - Part B | Change from Baseline at Follow-up Day 28 | -0.053 mmol/L | Standard Deviation 1.1142 |
| Part A: SAGE-217 | Change From Baseline in Glucose - Part B | Change from Baseline at Day 8 | 0.103 mmol/L | Standard Deviation 1.4778 |
| Part A: SAGE-217 | Change From Baseline in Glucose - Part B | Change from Baseline at Follow-up Day 35 | -0.094 mmol/L | Standard Deviation 1.5798 |
| Part A: SAGE-217 | Change From Baseline in Glucose - Part B | Change from Baseline at Follow-up Day 21 | -0.031 mmol/L | Standard Deviation 1.2125 |
| Part A: SAGE-217 | Change From Baseline in Glucose - Part B | Change from Baseline at Follow-up Day 42 | 0.114 mmol/L | Standard Deviation 1.3631 |
| Part A: SAGE-217 | Change From Baseline in Glucose - Part B | Baseline | 5.438 mmol/L | Standard Deviation 1.8453 |
| Part B: SAGE-217 | Change From Baseline in Glucose - Part B | Change from Baseline at Follow-up Day 42 | 0.059 mmol/L | Standard Deviation 1.1655 |
| Part B: SAGE-217 | Change From Baseline in Glucose - Part B | Baseline | 5.114 mmol/L | Standard Deviation 0.9726 |
| Part B: SAGE-217 | Change From Baseline in Glucose - Part B | Change from Baseline at Day 8 | 0.045 mmol/L | Standard Deviation 1.4529 |
| Part B: SAGE-217 | Change From Baseline in Glucose - Part B | Change from Baseline at Day 15/ET | 0.390 mmol/L | Standard Deviation 1.5054 |
| Part B: SAGE-217 | Change From Baseline in Glucose - Part B | Change from Baseline at Follow-up Day 21 | -0.308 mmol/L | Standard Deviation 1.3738 |
| Part B: SAGE-217 | Change From Baseline in Glucose - Part B | Change from Baseline at Follow-up Day 28 | 0.166 mmol/L | Standard Deviation 1.3791 |
| Part B: SAGE-217 | Change From Baseline in Glucose - Part B | Change from Baseline at Follow-up Day 35 | 0.355 mmol/L | Standard Deviation 1.6032 |
Secondary
Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B
The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms, and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scoring for HAM-A was calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56, where 0-13=Normal, 14-17 Mild Anxiety, 18-24 Moderate Anxiety, \>=25 Severe Anxiety, per the Psych Congress Network. The HAM-A total score was calculated as the sum of the 14 individual item scores. A negative change from baseline indicated less anxiety. A positive change from baseline indicated more anxiety. The analysis was performed in participants included in Part B of the study.
Time frame: Baseline, Days 2, 8, 15, 21, 28, 35 and 42
Population: The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 15 | -8.6 score on a scale | Standard Error 1.11 |
| Part A: SAGE-217 | Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 28 | -10.0 score on a scale | Standard Error 1.26 |
| Part A: SAGE-217 | Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 8 | -8.9 score on a scale | Standard Error 1.09 |
| Part A: SAGE-217 | Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 35 | -9.9 score on a scale | Standard Error 1.38 |
| Part A: SAGE-217 | Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 21 | -9.5 score on a scale | Standard Error 1.25 |
| Part A: SAGE-217 | Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 42 | -9.6 score on a scale | Standard Error 1.39 |
| Part A: SAGE-217 | Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 2 | -3.7 score on a scale | Standard Error 0.86 |
| Part B: SAGE-217 | Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 42 | -11.8 score on a scale | Standard Error 1.35 |
| Part B: SAGE-217 | Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 2 | -5.5 score on a scale | Standard Error 0.83 |
| Part B: SAGE-217 | Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 8 | -11.4 score on a scale | Standard Error 1.06 |
| Part B: SAGE-217 | Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 15 | -13.2 score on a scale | Standard Error 1.08 |
| Part B: SAGE-217 | Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 21 | -12.9 score on a scale | Standard Error 1.21 |
| Part B: SAGE-217 | Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 28 | -12.2 score on a scale | Standard Error 1.22 |
| Part B: SAGE-217 | Change From Baseline in HAM-A Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 35 | -12.0 score on a scale | Standard Error 1.35 |
Comparison: Day 42p-value: 0.203795% CI: [-5.7, 1.2]Mixed Effect Model for Repeated Measures
Comparison: Day 2p-value: 0.039195% CI: [-3.6, -0.1]Mixed Effect Model for Repeated Measures
Comparison: Day 8p-value: 0.051695% CI: [-5.1, 0]Mixed Effect Model for Repeated Measures
Comparison: Day 15p-value: 0.000895% CI: [-7.3, -2]Mixed Effect Model for Repeated Measures
Comparison: Day 21p-value: 0.028295% CI: [-6.5, -0.4]Mixed Effect Model for Repeated Measures
Comparison: Day 28p-value: 0.168695% CI: [-5.3, 0.9]Mixed Effect Model for Repeated Measures
Comparison: Day 35p-value: 0.248895% CI: [-5.5, 1.5]Mixed Effect Model for Repeated Measures
Secondary
Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B
HAM-D subscales were: Core, symptoms: depressed mood (DM), feelings of guilt (FG), suicide, work and activities (WA), and retardation (RE); Anxiety, symptoms: anxiety (psychic and somatic), somatic symptoms (SS) (gastrointestinal and general), hypochondriasis, and loss of weight; Bech-6, symptoms: DM, FG, WA, RE, anxiety psychic (AP), and SS general; and Maier, symptoms: DM, FG, WA, RE, agitation, and AP. Each item was scored in a range of 0 to 2 or 0 to 4. Higher scores indicated a greater degree of depression. Subscale scores were calculated as sum of individual rating scores related to each subscale, divided by total possible score within subscale, multiplied by 100, and rounded to a whole number. Therefore, subscale scores would be within range of 0-100 and might be larger than total score. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of study.
Time frame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21, 28, 35 and 42
Population: The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. Number analyzed: Number of participants in efficacy set with a non-missing value at both baseline and visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Baseline | 60.1 score on a scale | Standard Deviation 7.12 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 8 | -22.5 score on a scale | Standard Deviation 16.28 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 2 | -6.8 score on a scale | Standard Deviation 9.71 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 2 | -8.4 score on a scale | Standard Deviation 10.51 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 3 | -11.3 score on a scale | Standard Deviation 9.38 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 5 | -15.8 score on a scale | Standard Deviation 12.39 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 4 | -17.0 score on a scale | Standard Deviation 13.92 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 3 | -12.5 score on a scale | Standard Deviation 10.21 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 5 | -19.5 score on a scale | Standard Deviation 16.61 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 15 | -21.9 score on a scale | Standard Deviation 17.94 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 6 | -21.4 score on a scale | Standard Deviation 16.76 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 4 | -17.5 score on a scale | Standard Deviation 17.17 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 7 | -22.8 score on a scale | Standard Deviation 18.88 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 2 | -5.9 score on a scale | Standard Deviation 6.84 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 8 | -27.5 score on a scale | Standard Deviation 19.47 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 5 | -18.5 score on a scale | Standard Deviation 18.72 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 15 | -26.3 score on a scale | Standard Deviation 21.07 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 21 | -22.9 score on a scale | Standard Deviation 17.77 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 21 | -27.9 score on a scale | Standard Deviation 20.69 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 6 | -18.8 score on a scale | Standard Deviation 18.3 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 28 | -27.7 score on a scale | Standard Deviation 21.02 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 6 | -17.5 score on a scale | Standard Deviation 14.04 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 35 | -29.3 score on a scale | Standard Deviation 22.03 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 7 | -19.5 score on a scale | Standard Deviation 17.65 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 42 | -30.2 score on a scale | Standard Deviation 22.34 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 28 | -22.1 score on a scale | Standard Deviation 17.42 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Baseline | 51.1 score on a scale | Standard Deviation 6.56 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 8 | -21.5 score on a scale | Standard Deviation 18.32 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 2 | -6.3 score on a scale | Standard Deviation 8.68 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 4 | -13.3 score on a scale | Standard Deviation 10.85 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 3 | -9.6 score on a scale | Standard Deviation 8.54 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 15 | -20.5 score on a scale | Standard Deviation 17.11 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 4 | -14.1 score on a scale | Standard Deviation 12.47 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 35 | -24.3 score on a scale | Standard Deviation 17.34 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 5 | -17.3 score on a scale | Standard Deviation 13.74 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 21 | -23.6 score on a scale | Standard Deviation 18.67 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 6 | -18.2 score on a scale | Standard Deviation 14.24 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 7 | -18.0 score on a scale | Standard Deviation 15.97 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 7 | -19.4 score on a scale | Standard Deviation 16.85 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 28 | -23.1 score on a scale | Standard Deviation 20.34 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 8 | -24.6 score on a scale | Standard Deviation 16.85 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 42 | -25.8 score on a scale | Standard Deviation 17.79 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 15 | -22.6 score on a scale | Standard Deviation 17.15 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 35 | -24.9 score on a scale | Standard Deviation 20.74 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 21 | -23.8 score on a scale | Standard Deviation 18.08 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 3 | -9.4 score on a scale | Standard Deviation 9.16 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 28 | -24.2 score on a scale | Standard Deviation 17.57 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 42 | -22.9 score on a scale | Standard Deviation 21.6 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 35 | -25.5 score on a scale | Standard Deviation 17.89 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Baseline | 48.1 score on a scale | Standard Deviation 13.28 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 42 | -26.7 score on a scale | Standard Deviation 18.21 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Baseline | 47.3 score on a scale | Standard Deviation 6.86 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 42 | -29.1 score on a scale | Standard Deviation 18.27 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Baseline | 46.9 score on a scale | Standard Deviation 7.01 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 2 | -7.2 score on a scale | Standard Deviation 12.04 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 3 | -14.1 score on a scale | Standard Deviation 14.31 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 4 | -18.3 score on a scale | Standard Deviation 14.92 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 5 | -21.2 score on a scale | Standard Deviation 15.45 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 6 | -25.6 score on a scale | Standard Deviation 15.2 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 7 | -24.8 score on a scale | Standard Deviation 15.74 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 8 | -26.6 score on a scale | Standard Deviation 16.35 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 15 | -33.1 score on a scale | Standard Deviation 14.73 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 21 | -30.7 score on a scale | Standard Deviation 16.1 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 28 | -29.3 score on a scale | Standard Deviation 17.89 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 35 | -28.2 score on a scale | Standard Deviation 17.2 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Core: Change from Baseline at Day 42 | -28.0 score on a scale | Standard Deviation 18.41 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Baseline | 48.8 score on a scale | Standard Deviation 11.46 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 2 | -12.8 score on a scale | Standard Deviation 12.63 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 3 | -18.9 score on a scale | Standard Deviation 15.03 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 4 | -21.8 score on a scale | Standard Deviation 16.33 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 5 | -24.1 score on a scale | Standard Deviation 15.83 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 6 | -26.5 score on a scale | Standard Deviation 17.21 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 7 | -25.4 score on a scale | Standard Deviation 17.66 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 8 | -27.9 score on a scale | Standard Deviation 17.96 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 15 | -34.1 score on a scale | Standard Deviation 16.27 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 21 | -32.7 score on a scale | Standard Deviation 17.85 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 28 | -30.8 score on a scale | Standard Deviation 16.95 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 35 | -30.0 score on a scale | Standard Deviation 17.75 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Anxiety: Change from Baseline at Day 42 | -29.7 score on a scale | Standard Deviation 16.57 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Baseline | 59.8 score on a scale | Standard Deviation 7.23 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 2 | -10.2 score on a scale | Standard Deviation 14.55 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 3 | -18.8 score on a scale | Standard Deviation 17.93 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 4 | -23.8 score on a scale | Standard Deviation 19.11 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 5 | -26.8 score on a scale | Standard Deviation 19.32 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 6 | -32.0 score on a scale | Standard Deviation 20.13 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 7 | -31.4 score on a scale | Standard Deviation 19.69 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 8 | -33.0 score on a scale | Standard Deviation 20.08 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 15 | -41.8 score on a scale | Standard Deviation 17.78 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 21 | -38.8 score on a scale | Standard Deviation 20.8 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 28 | -36.1 score on a scale | Standard Deviation 21.86 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 35 | -35.0 score on a scale | Standard Deviation 21.51 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Bech-6: Change from Baseline at Day 42 | -34.7 score on a scale | Standard Deviation 22.35 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Baseline | 49.4 score on a scale | Standard Deviation 5.58 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 2 | -7.8 score on a scale | Standard Deviation 12.1 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 3 | -16.0 score on a scale | Standard Deviation 15.18 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 4 | -20.4 score on a scale | Standard Deviation 16.38 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 5 | -23.2 score on a scale | Standard Deviation 15.88 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 6 | -27.5 score on a scale | Standard Deviation 16.95 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 7 | -26.3 score on a scale | Standard Deviation 16.9 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 8 | -27.9 score on a scale | Standard Deviation 16.72 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 15 | -35.1 score on a scale | Standard Deviation 14.55 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 21 | -32.5 score on a scale | Standard Deviation 16.88 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 28 | -30.8 score on a scale | Standard Deviation 17.36 |
| Part B: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at All Time Points - Part B | Meier: Change from Baseline at Day 35 | -29.5 score on a scale | Standard Deviation 18.24 |
Secondary
Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A
HAM-D subscales were: Core, symptoms: depressed mood (DM), feelings of guilt (FG), suicide, work and activities (WA), and retardation (RE); Anxiety, symptoms: anxiety (psychic and somatic), somatic symptoms (SS) (gastrointestinal and general), hypochondriasis, and loss of weight; Bech-6, symptoms: DM, FG, WA, RE, anxiety psychic (AP), and SS general; and Maier, symptoms: DM, FG, WA, RE, agitation, and AP. Each item was scored in a range of 0 to 2 or 0 to 4. Higher scores indicated a greater degree of depression. Subscale scores were calculated as sum of individual rating scores related to each subscale, divided by total possible score within subscale, multiplied by 100, and rounded to a whole number. Therefore, subscale scores would be within range of 0-100 and might be larger than total score. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of study.
Time frame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28
Population: The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Core: Baseline | 45.0 score on a scale | Standard Deviation 5.77 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Core: Change from Baseline at Day 2 | -5.4 score on a scale | Standard Deviation 8.03 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Core: Change from Baseline at Day 3 | -12.3 score on a scale | Standard Deviation 11.48 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Core: Change from Baseline at Day 4 | -18.5 score on a scale | Standard Deviation 13.9 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Core: Change from Baseline at Day 5 | -21.9 score on a scale | Standard Deviation 14.22 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Core: Change from Baseline at Day 6 | -25.4 score on a scale | Standard Deviation 11.27 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Core: Change from Baseline at Day 7 | -25.4 score on a scale | Standard Deviation 15.06 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Core: Change from Baseline at Day 8 | -28.8 score on a scale | Standard Deviation 14.88 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Core: Change from Baseline at Day 15 | -34.6 score on a scale | Standard Deviation 12.98 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Core: Change from Baseline at Day 21 | -35.0 score on a scale | Standard Deviation 15.68 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Core: Change from Baseline at Day 28 | -33.5 score on a scale | Standard Deviation 16.88 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Anxiety: Baseline | 50.1 score on a scale | Standard Deviation 10.52 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Anxiety: Change from Baseline at Day 2 | -10.4 score on a scale | Standard Deviation 8.89 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Anxiety: Change from Baseline at Day 3 | -15.4 score on a scale | Standard Deviation 9.79 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Anxiety: Change from Baseline at Day 4 | -21.8 score on a scale | Standard Deviation 12.16 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Anxiety: Change from Baseline at Day 5 | -24.9 score on a scale | Standard Deviation 14.23 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Anxiety: Change from Baseline at Day 6 | -29.1 score on a scale | Standard Deviation 13.7 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Anxiety: Change from Baseline at Day 7 | -29.2 score on a scale | Standard Deviation 13.44 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Anxiety: Change from Baseline at Day 8 | -32.5 score on a scale | Standard Deviation 15.86 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Anxiety: Change from Baseline at Day 15 | -34.2 score on a scale | Standard Deviation 14.73 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Anxiety: Change from Baseline at Day 21 | -34.2 score on a scale | Standard Deviation 14.62 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Anxiety: Change from Baseline at Day 28 | -34.2 score on a scale | Standard Deviation 15.79 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Bech-6: Baseline | 61.6 score on a scale | Standard Deviation 7.38 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Bech-6: Change from Baseline at Day 2 | -8.2 score on a scale | Standard Deviation 11.02 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Bech-6: Change from Baseline at Day 3 | -16.6 score on a scale | Standard Deviation 14.52 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Bech-6: Change from Baseline at Day 4 | -25.5 score on a scale | Standard Deviation 17.43 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Bech-6: Change from Baseline at Day 5 | -29.4 score on a scale | Standard Deviation 16.94 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Bech-6: Change from Baseline at Day 6 | -34.0 score on a scale | Standard Deviation 16.8 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Bech-6: Change from Baseline at Day 7 | -34.4 score on a scale | Standard Deviation 17.82 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Bech-6: Change from Baseline at Day 8 | -38.9 score on a scale | Standard Deviation 18.23 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Bech-6: Change from Baseline at Day 15 | -45.4 score on a scale | Standard Deviation 16.04 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Bech-6: Change from Baseline at Day 21 | -44.5 score on a scale | Standard Deviation 20.11 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Bech-6: Change from Baseline at Day 28 | -42.2 score on a scale | Standard Deviation 22.12 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Meier: Baseline | 54.2 score on a scale | Standard Deviation 8.57 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Meier: Change from Baseline at Day 2 | -7.1 score on a scale | Standard Deviation 8.8 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Meier: Change from Baseline at Day 3 | -16.1 score on a scale | Standard Deviation 10.87 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Meier: Change from Baseline at Day 4 | -23.6 score on a scale | Standard Deviation 11.99 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Meier: Change from Baseline at Day 5 | -27.2 score on a scale | Standard Deviation 12.55 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Meier: Change from Baseline at Day 6 | -31.6 score on a scale | Standard Deviation 12.13 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Meier: Change from Baseline at Day 7 | -31.7 score on a scale | Standard Deviation 14.49 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Meier: Change from Baseline at Day 8 | -35.7 score on a scale | Standard Deviation 14.57 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Meier: Change from Baseline at Day 15 | -40.4 score on a scale | Standard Deviation 13.78 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Meier: Change from Baseline at Day 21 | -40.5 score on a scale | Standard Deviation 17.23 |
| Part A: SAGE-217 | Change From Baseline in HAM-D Subscale Scores at Day 15 and All Other Time Points - Part A | Meier: Change from Baseline at Day 28 | -38.2 score on a scale | Standard Deviation 18.78 |
Secondary
Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points - Part A
The 14-item HAM-A was used to rate the severity of symptoms of anxiety. Each of the 14 items was defined by a series of symptoms, and measured both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Scoring for HAM-A was calculated by assigning scores of 0 (not present) to 4 (very severe), with a total score range of 0 to 56, where 0-13=Normal, 14-17 Mild Anxiety, 18-24 Moderate Anxiety, \>=25 Severe Anxiety, per the Psych Congress Network. The HAM-A total score was calculated as the sum of the 14 individual item scores. A negative change from baseline indicated less anxiety. A positive change from baseline indicated more anxiety. The analysis was performed in participants included in Part A of the study.
Time frame: Baseline, Days 2, 3, 8, 15, 21 and 28
Population: The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points - Part A | Baseline | 23.2 score on a scale | Standard Deviation 5.65 |
| Part A: SAGE-217 | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points - Part A | Change from Baseline at Day 2 | -2.8 score on a scale | Standard Deviation 3.44 |
| Part A: SAGE-217 | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points - Part A | Change from Baseline at Day 3 | -5.6 score on a scale | Standard Deviation 3.59 |
| Part A: SAGE-217 | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points - Part A | Change from Baseline at Day 8 | -13.3 score on a scale | Standard Deviation 6.25 |
| Part A: SAGE-217 | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points - Part A | Change from Baseline at Day 15 | -15.5 score on a scale | Standard Deviation 6.19 |
| Part A: SAGE-217 | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points - Part A | Change from Baseline at Day 21 | -15.6 score on a scale | Standard Deviation 7.05 |
| Part A: SAGE-217 | Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at All Time Points - Part A | Change from Baseline at Day 28 | -15.5 score on a scale | Standard Deviation 7.22 |
Secondary
Change From Baseline in Hematocrit - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Hematocrit - Part B | Change from Baseline at Day 15/ET | -0.006 fraction of one | Standard Deviation 0.021 |
| Part A: SAGE-217 | Change From Baseline in Hematocrit - Part B | Change from Baseline at Follow-up Day 28 | -0.015 fraction of one | Standard Deviation 0.0235 |
| Part A: SAGE-217 | Change From Baseline in Hematocrit - Part B | Change from Baseline at Day 8 | -0.004 fraction of one | Standard Deviation 0.024 |
| Part A: SAGE-217 | Change From Baseline in Hematocrit - Part B | Change from Baseline at Follow-up Day 35 | -0.011 fraction of one | Standard Deviation 0.0253 |
| Part A: SAGE-217 | Change From Baseline in Hematocrit - Part B | Change from Baseline at Follow-up Day 21 | -0.015 fraction of one | Standard Deviation 0.0233 |
| Part A: SAGE-217 | Change From Baseline in Hematocrit - Part B | Change from Baseline at Follow-up Day 42 | -0.015 fraction of one | Standard Deviation 0.0223 |
| Part A: SAGE-217 | Change From Baseline in Hematocrit - Part B | Baseline | 0.424 fraction of one | Standard Deviation 0.0372 |
| Part B: SAGE-217 | Change From Baseline in Hematocrit - Part B | Change from Baseline at Follow-up Day 42 | -0.019 fraction of one | Standard Deviation 0.0245 |
| Part B: SAGE-217 | Change From Baseline in Hematocrit - Part B | Baseline | 0.436 fraction of one | Standard Deviation 0.0389 |
| Part B: SAGE-217 | Change From Baseline in Hematocrit - Part B | Change from Baseline at Day 8 | -0.004 fraction of one | Standard Deviation 0.0281 |
| Part B: SAGE-217 | Change From Baseline in Hematocrit - Part B | Change from Baseline at Day 15/ET | -0.010 fraction of one | Standard Deviation 0.023 |
| Part B: SAGE-217 | Change From Baseline in Hematocrit - Part B | Change from Baseline at Follow-up Day 21 | -0.020 fraction of one | Standard Deviation 0.0249 |
| Part B: SAGE-217 | Change From Baseline in Hematocrit - Part B | Change from Baseline at Follow-up Day 28 | -0.015 fraction of one | Standard Deviation 0.022 |
| Part B: SAGE-217 | Change From Baseline in Hematocrit - Part B | Change from Baseline at Follow-up Day 35 | -0.015 fraction of one | Standard Deviation 0.0244 |
Secondary
Change From Baseline in Hemoglobin - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Hemoglobin - Part B | Change from Baseline at Day 15/ET | -1.8 g/L | Standard Deviation 6.88 |
| Part A: SAGE-217 | Change From Baseline in Hemoglobin - Part B | Change from Baseline at Follow-up Day 28 | -4.9 g/L | Standard Deviation 7.44 |
| Part A: SAGE-217 | Change From Baseline in Hemoglobin - Part B | Change from Baseline at Day 8 | -1.3 g/L | Standard Deviation 7.72 |
| Part A: SAGE-217 | Change From Baseline in Hemoglobin - Part B | Change from Baseline at Follow-up Day 35 | -3.8 g/L | Standard Deviation 8.16 |
| Part A: SAGE-217 | Change From Baseline in Hemoglobin - Part B | Change from Baseline at Follow-up Day 21 | -5.2 g/L | Standard Deviation 7.41 |
| Part A: SAGE-217 | Change From Baseline in Hemoglobin - Part B | Change from Baseline at Follow-up Day 42 | -4.7 g/L | Standard Deviation 6.44 |
| Part A: SAGE-217 | Change From Baseline in Hemoglobin - Part B | Baseline | 136.1 g/L | Standard Deviation 13.79 |
| Part B: SAGE-217 | Change From Baseline in Hemoglobin - Part B | Change from Baseline at Follow-up Day 42 | -5.6 g/L | Standard Deviation 8.18 |
| Part B: SAGE-217 | Change From Baseline in Hemoglobin - Part B | Baseline | 141.0 g/L | Standard Deviation 14.98 |
| Part B: SAGE-217 | Change From Baseline in Hemoglobin - Part B | Change from Baseline at Day 8 | -2.3 g/L | Standard Deviation 9.09 |
| Part B: SAGE-217 | Change From Baseline in Hemoglobin - Part B | Change from Baseline at Day 15/ET | -3.8 g/L | Standard Deviation 7.8 |
| Part B: SAGE-217 | Change From Baseline in Hemoglobin - Part B | Change from Baseline at Follow-up Day 21 | -6.6 g/L | Standard Deviation 7.91 |
| Part B: SAGE-217 | Change From Baseline in Hemoglobin - Part B | Change from Baseline at Follow-up Day 28 | -4.9 g/L | Standard Deviation 7.29 |
| Part B: SAGE-217 | Change From Baseline in Hemoglobin - Part B | Change from Baseline at Follow-up Day 35 | -5.1 g/L | Standard Deviation 8.18 |
Secondary
Change From Baseline in Leukocytes - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Leukocytes - Part B | Change from Baseline at Day 15/ET | -0.27 10^9 cells/L | Standard Deviation 1.435 |
| Part A: SAGE-217 | Change From Baseline in Leukocytes - Part B | Change from Baseline at Follow-up Day 28 | -0.34 10^9 cells/L | Standard Deviation 1.266 |
| Part A: SAGE-217 | Change From Baseline in Leukocytes - Part B | Change from Baseline at Day 8 | -0.11 10^9 cells/L | Standard Deviation 1.324 |
| Part A: SAGE-217 | Change From Baseline in Leukocytes - Part B | Change from Baseline at Follow-up Day 35 | -0.32 10^9 cells/L | Standard Deviation 1.355 |
| Part A: SAGE-217 | Change From Baseline in Leukocytes - Part B | Change from Baseline at Follow-up Day 21 | -0.41 10^9 cells/L | Standard Deviation 1.258 |
| Part A: SAGE-217 | Change From Baseline in Leukocytes - Part B | Change from Baseline at Follow-up Day 42 | -0.69 10^9 cells/L | Standard Deviation 1.421 |
| Part A: SAGE-217 | Change From Baseline in Leukocytes - Part B | Baseline | 7.08 10^9 cells/L | Standard Deviation 1.778 |
| Part B: SAGE-217 | Change From Baseline in Leukocytes - Part B | Change from Baseline at Follow-up Day 42 | -0.45 10^9 cells/L | Standard Deviation 1.443 |
| Part B: SAGE-217 | Change From Baseline in Leukocytes - Part B | Baseline | 6.63 10^9 cells/L | Standard Deviation 1.688 |
| Part B: SAGE-217 | Change From Baseline in Leukocytes - Part B | Change from Baseline at Day 8 | -0.40 10^9 cells/L | Standard Deviation 1.913 |
| Part B: SAGE-217 | Change From Baseline in Leukocytes - Part B | Change from Baseline at Day 15/ET | -0.34 10^9 cells/L | Standard Deviation 1.241 |
| Part B: SAGE-217 | Change From Baseline in Leukocytes - Part B | Change from Baseline at Follow-up Day 21 | -0.35 10^9 cells/L | Standard Deviation 1.41 |
| Part B: SAGE-217 | Change From Baseline in Leukocytes - Part B | Change from Baseline at Follow-up Day 28 | -0.70 10^9 cells/L | Standard Deviation 1.348 |
| Part B: SAGE-217 | Change From Baseline in Leukocytes - Part B | Change from Baseline at Follow-up Day 35 | -0.70 10^9 cells/L | Standard Deviation 0.993 |
Secondary
Change From Baseline in Lymphocytes - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Lymphocytes - Part B | Change from Baseline at Day 15/ET | 0.066 10^9 cells/L | Standard Deviation 0.5139 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes - Part B | Change from Baseline at Follow-up Day 28 | -0.073 10^9 cells/L | Standard Deviation 0.5071 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes - Part B | Change from Baseline at Day 8 | -0.053 10^9 cells/L | Standard Deviation 0.4033 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes - Part B | Change from Baseline at Follow-up Day 35 | -0.153 10^9 cells/L | Standard Deviation 0.4178 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes - Part B | Change from Baseline at Follow-up Day 21 | -0.106 10^9 cells/L | Standard Deviation 0.5656 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes - Part B | Change from Baseline at Follow-up Day 42 | -0.168 10^9 cells/L | Standard Deviation 0.4661 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes - Part B | Baseline | 2.294 10^9 cells/L | Standard Deviation 0.6093 |
| Part B: SAGE-217 | Change From Baseline in Lymphocytes - Part B | Change from Baseline at Follow-up Day 42 | -0.133 10^9 cells/L | Standard Deviation 0.4544 |
| Part B: SAGE-217 | Change From Baseline in Lymphocytes - Part B | Baseline | 2.162 10^9 cells/L | Standard Deviation 0.6275 |
| Part B: SAGE-217 | Change From Baseline in Lymphocytes - Part B | Change from Baseline at Day 8 | -0.054 10^9 cells/L | Standard Deviation 0.4501 |
| Part B: SAGE-217 | Change From Baseline in Lymphocytes - Part B | Change from Baseline at Day 15/ET | 0.025 10^9 cells/L | Standard Deviation 0.4944 |
| Part B: SAGE-217 | Change From Baseline in Lymphocytes - Part B | Change from Baseline at Follow-up Day 21 | -0.104 10^9 cells/L | Standard Deviation 0.5341 |
| Part B: SAGE-217 | Change From Baseline in Lymphocytes - Part B | Change from Baseline at Follow-up Day 28 | -0.247 10^9 cells/L | Standard Deviation 0.5428 |
| Part B: SAGE-217 | Change From Baseline in Lymphocytes - Part B | Change from Baseline at Follow-up Day 35 | -0.209 10^9 cells/L | Standard Deviation 0.5137 |
Secondary
Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 15/ET | 1.25 percentage | Standard Deviation 7.203 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 28 | 0.61 percentage | Standard Deviation 9.038 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 8 | -0.43 percentage | Standard Deviation 6.613 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 35 | -0.75 percentage | Standard Deviation 7.861 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 21 | 0.04 percentage | Standard Deviation 7.177 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 42 | 0.91 percentage | Standard Deviation 6.96 |
| Part A: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B | Baseline | 33.06 percentage | Standard Deviation 7.144 |
| Part B: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 42 | 0.30 percentage | Standard Deviation 8.641 |
| Part B: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B | Baseline | 33.87 percentage | Standard Deviation 10.189 |
| Part B: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 8 | 1.86 percentage | Standard Deviation 7.057 |
| Part B: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 15/ET | 1.96 percentage | Standard Deviation 8.304 |
| Part B: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 21 | -0.13 percentage | Standard Deviation 9.353 |
| Part B: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 28 | -0.61 percentage | Standard Deviation 9.527 |
| Part B: SAGE-217 | Change From Baseline in Lymphocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 35 | -0.02 percentage | Standard Deviation 8.937 |
Secondary
Change From Baseline in Magnesium - Part B
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Magnesium - Part B | Change from Baseline at Day 15/ET | -0.025 mmol/L | Standard Deviation 0.098 |
| Part A: SAGE-217 | Change From Baseline in Magnesium - Part B | Change from Baseline at Follow-up Day 28 | -0.009 mmol/L | Standard Deviation 0.0996 |
| Part A: SAGE-217 | Change From Baseline in Magnesium - Part B | Change from Baseline at Day 8 | -0.020 mmol/L | Standard Deviation 0.0911 |
| Part A: SAGE-217 | Change From Baseline in Magnesium - Part B | Change from Baseline at Follow-up Day 35 | -0.033 mmol/L | Standard Deviation 0.0981 |
| Part A: SAGE-217 | Change From Baseline in Magnesium - Part B | Change from Baseline at Follow-up Day 21 | -0.023 mmol/L | Standard Deviation 0.0864 |
| Part A: SAGE-217 | Change From Baseline in Magnesium - Part B | Change from Baseline at Follow-up Day 42 | -0.012 mmol/L | Standard Deviation 0.107 |
| Part A: SAGE-217 | Change From Baseline in Magnesium - Part B | Baseline | 0.891 mmol/L | Standard Deviation 0.0772 |
| Part B: SAGE-217 | Change From Baseline in Magnesium - Part B | Change from Baseline at Follow-up Day 42 | -0.025 mmol/L | Standard Deviation 0.0929 |
| Part B: SAGE-217 | Change From Baseline in Magnesium - Part B | Baseline | 0.879 mmol/L | Standard Deviation 0.0977 |
| Part B: SAGE-217 | Change From Baseline in Magnesium - Part B | Change from Baseline at Day 8 | -0.011 mmol/L | Standard Deviation 0.095 |
| Part B: SAGE-217 | Change From Baseline in Magnesium - Part B | Change from Baseline at Day 15/ET | -0.014 mmol/L | Standard Deviation 0.1095 |
| Part B: SAGE-217 | Change From Baseline in Magnesium - Part B | Change from Baseline at Follow-up Day 21 | -0.025 mmol/L | Standard Deviation 0.0998 |
| Part B: SAGE-217 | Change From Baseline in Magnesium - Part B | Change from Baseline at Follow-up Day 28 | -0.030 mmol/L | Standard Deviation 0.0804 |
| Part B: SAGE-217 | Change From Baseline in Magnesium - Part B | Change from Baseline at Follow-up Day 35 | -0.033 mmol/L | Standard Deviation 0.1046 |
Secondary
Change From Baseline in Monocytes - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Monocytes - Part B | Change from Baseline at Day 15/ET | 0.017 10^9 cells/L | Standard Deviation 0.1253 |
| Part A: SAGE-217 | Change From Baseline in Monocytes - Part B | Change from Baseline at Follow-up Day 28 | 0.045 10^9 cells/L | Standard Deviation 0.1415 |
| Part A: SAGE-217 | Change From Baseline in Monocytes - Part B | Change from Baseline at Day 8 | 0.003 10^9 cells/L | Standard Deviation 0.1209 |
| Part A: SAGE-217 | Change From Baseline in Monocytes - Part B | Change from Baseline at Follow-up Day 35 | 0.024 10^9 cells/L | Standard Deviation 0.1364 |
| Part A: SAGE-217 | Change From Baseline in Monocytes - Part B | Change from Baseline at Follow-up Day 21 | 0.007 10^9 cells/L | Standard Deviation 0.1063 |
| Part A: SAGE-217 | Change From Baseline in Monocytes - Part B | Change from Baseline at Follow-up Day 42 | 0.011 10^9 cells/L | Standard Deviation 0.105 |
| Part A: SAGE-217 | Change From Baseline in Monocytes - Part B | Baseline | 0.442 10^9 cells/L | Standard Deviation 0.1206 |
| Part B: SAGE-217 | Change From Baseline in Monocytes - Part B | Change from Baseline at Follow-up Day 42 | 0.004 10^9 cells/L | Standard Deviation 0.1313 |
| Part B: SAGE-217 | Change From Baseline in Monocytes - Part B | Baseline | 0.438 10^9 cells/L | Standard Deviation 0.1339 |
| Part B: SAGE-217 | Change From Baseline in Monocytes - Part B | Change from Baseline at Day 8 | 0.035 10^9 cells/L | Standard Deviation 0.1631 |
| Part B: SAGE-217 | Change From Baseline in Monocytes - Part B | Change from Baseline at Day 15/ET | 0.028 10^9 cells/L | Standard Deviation 0.1185 |
| Part B: SAGE-217 | Change From Baseline in Monocytes - Part B | Change from Baseline at Follow-up Day 21 | 0.025 10^9 cells/L | Standard Deviation 0.1333 |
| Part B: SAGE-217 | Change From Baseline in Monocytes - Part B | Change from Baseline at Follow-up Day 28 | -0.010 10^9 cells/L | Standard Deviation 0.1523 |
| Part B: SAGE-217 | Change From Baseline in Monocytes - Part B | Change from Baseline at Follow-up Day 35 | 0.002 10^9 cells/L | Standard Deviation 0.1381 |
Secondary
Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 15/ET | 0.40 percentage | Standard Deviation 1.942 |
| Part A: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 28 | 0.97 percentage | Standard Deviation 1.869 |
| Part A: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 8 | 0.20 percentage | Standard Deviation 1.43 |
| Part A: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 35 | 0.66 percentage | Standard Deviation 1.546 |
| Part A: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 21 | 0.57 percentage | Standard Deviation 1.473 |
| Part A: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 42 | 0.94 percentage | Standard Deviation 1.27 |
| Part A: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B | Baseline | 6.33 percentage | Standard Deviation 1.76 |
| Part B: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 42 | 0.74 percentage | Standard Deviation 2.076 |
| Part B: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B | Baseline | 6.78 percentage | Standard Deviation 1.97 |
| Part B: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 8 | 0.98 percentage | Standard Deviation 1.661 |
| Part B: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 15/ET | 0.79 percentage | Standard Deviation 1.617 |
| Part B: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 21 | 0.90 percentage | Standard Deviation 2.03 |
| Part B: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 28 | 0.77 percentage | Standard Deviation 2.562 |
| Part B: SAGE-217 | Change From Baseline in Monocytes to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 35 | 0.78 percentage | Standard Deviation 2.374 |
Secondary
Change From Baseline in Neutrophils - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Neutrophils - Part B | Change from Baseline at Day 15/ET | -0.389 10^9 cells/L | Standard Deviation 1.2882 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils - Part B | Change from Baseline at Follow-up Day 28 | -0.363 10^9 cells/L | Standard Deviation 1.2994 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils - Part B | Change from Baseline at Day 8 | -0.100 10^9 cells/L | Standard Deviation 1.1146 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils - Part B | Change from Baseline at Follow-up Day 35 | -0.209 10^9 cells/L | Standard Deviation 1.325 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils - Part B | Change from Baseline at Follow-up Day 21 | -0.354 10^9 cells/L | Standard Deviation 1.0854 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils - Part B | Change from Baseline at Follow-up Day 42 | -0.584 10^9 cells/L | Standard Deviation 1.2204 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils - Part B | Baseline | 4.174 10^9 cells/L | Standard Deviation 1.4046 |
| Part B: SAGE-217 | Change From Baseline in Neutrophils - Part B | Change from Baseline at Follow-up Day 42 | -0.323 10^9 cells/L | Standard Deviation 1.4669 |
| Part B: SAGE-217 | Change From Baseline in Neutrophils - Part B | Baseline | 3.852 10^9 cells/L | Standard Deviation 1.5129 |
| Part B: SAGE-217 | Change From Baseline in Neutrophils - Part B | Change from Baseline at Day 8 | -0.399 10^9 cells/L | Standard Deviation 1.7192 |
| Part B: SAGE-217 | Change From Baseline in Neutrophils - Part B | Change from Baseline at Day 15/ET | -0.406 10^9 cells/L | Standard Deviation 1.2479 |
| Part B: SAGE-217 | Change From Baseline in Neutrophils - Part B | Change from Baseline at Follow-up Day 21 | -0.280 10^9 cells/L | Standard Deviation 1.3687 |
| Part B: SAGE-217 | Change From Baseline in Neutrophils - Part B | Change from Baseline at Follow-up Day 28 | -0.454 10^9 cells/L | Standard Deviation 1.3814 |
| Part B: SAGE-217 | Change From Baseline in Neutrophils - Part B | Change from Baseline at Follow-up Day 35 | -0.494 10^9 cells/L | Standard Deviation 1.0343 |
Secondary
Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 15/ET | -2.23 percentage | Standard Deviation 8.6 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 28 | -2.11 percentage | Standard Deviation 10.514 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 8 | -0.03 percentage | Standard Deviation 7.549 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 35 | -0.38 percentage | Standard Deviation 9.087 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 21 | -1.15 percentage | Standard Deviation 8.173 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 42 | -2.50 percentage | Standard Deviation 7.678 |
| Part A: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B | Baseline | 58.03 percentage | Standard Deviation 7.85 |
| Part B: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 42 | -1.58 percentage | Standard Deviation 9.818 |
| Part B: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B | Baseline | 56.76 percentage | Standard Deviation 10.809 |
| Part B: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 8 | -3.32 percentage | Standard Deviation 8.015 |
| Part B: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Day 15/ET | -3.46 percentage | Standard Deviation 9.345 |
| Part B: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 21 | -1.32 percentage | Standard Deviation 10.154 |
| Part B: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 28 | -0.63 percentage | Standard Deviation 11.16 |
| Part B: SAGE-217 | Change From Baseline in Neutrophils to Leukocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 35 | -1.22 percentage | Standard Deviation 9.6 |
Secondary
Change From Baseline in Phosphate - Part B
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Phosphate - Part B | Change from Baseline at Day 15/ET | 0.019 mmol/L | Standard Deviation 0.1969 |
| Part A: SAGE-217 | Change From Baseline in Phosphate - Part B | Change from Baseline at Follow-up Day 28 | -0.022 mmol/L | Standard Deviation 0.1657 |
| Part A: SAGE-217 | Change From Baseline in Phosphate - Part B | Change from Baseline at Day 8 | 0.053 mmol/L | Standard Deviation 0.205 |
| Part A: SAGE-217 | Change From Baseline in Phosphate - Part B | Change from Baseline at Follow-up Day 35 | -0.108 mmol/L | Standard Deviation 0.1761 |
| Part A: SAGE-217 | Change From Baseline in Phosphate - Part B | Change from Baseline at Follow-up Day 21 | -0.015 mmol/L | Standard Deviation 0.1609 |
| Part A: SAGE-217 | Change From Baseline in Phosphate - Part B | Change from Baseline at Follow-up Day 42 | -0.102 mmol/L | Standard Deviation 0.16 |
| Part A: SAGE-217 | Change From Baseline in Phosphate - Part B | Baseline | 1.245 mmol/L | Standard Deviation 0.1623 |
| Part B: SAGE-217 | Change From Baseline in Phosphate - Part B | Change from Baseline at Follow-up Day 42 | -0.089 mmol/L | Standard Deviation 0.1941 |
| Part B: SAGE-217 | Change From Baseline in Phosphate - Part B | Baseline | 1.212 mmol/L | Standard Deviation 0.1359 |
| Part B: SAGE-217 | Change From Baseline in Phosphate - Part B | Change from Baseline at Day 8 | 0.048 mmol/L | Standard Deviation 0.2078 |
| Part B: SAGE-217 | Change From Baseline in Phosphate - Part B | Change from Baseline at Day 15/ET | 0.010 mmol/L | Standard Deviation 0.1798 |
| Part B: SAGE-217 | Change From Baseline in Phosphate - Part B | Change from Baseline at Follow-up Day 21 | -0.102 mmol/L | Standard Deviation 0.1652 |
| Part B: SAGE-217 | Change From Baseline in Phosphate - Part B | Change from Baseline at Follow-up Day 28 | -0.084 mmol/L | Standard Deviation 0.2291 |
| Part B: SAGE-217 | Change From Baseline in Phosphate - Part B | Change from Baseline at Follow-up Day 35 | -0.120 mmol/L | Standard Deviation 0.2033 |
Secondary
Change From Baseline in pH - Part B
Urinalysis measures included pH and specific gravity. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in pH - Part B | Change from Baseline at Day 15/ET | -0.37 pH | Standard Deviation 0.877 |
| Part A: SAGE-217 | Change From Baseline in pH - Part B | Change from Baseline at Follow-up Day 28 | -0.27 pH | Standard Deviation 0.945 |
| Part A: SAGE-217 | Change From Baseline in pH - Part B | Change from Baseline at Day 8 | -0.32 pH | Standard Deviation 0.923 |
| Part A: SAGE-217 | Change From Baseline in pH - Part B | Change from Baseline at Follow-up Day 35 | -0.01 pH | Standard Deviation 1.275 |
| Part A: SAGE-217 | Change From Baseline in pH - Part B | Change from Baseline at Follow-up Day 21 | -0.32 pH | Standard Deviation 0.94 |
| Part A: SAGE-217 | Change From Baseline in pH - Part B | Change from Baseline at Follow-up Day 42 | -0.12 pH | Standard Deviation 1.109 |
| Part A: SAGE-217 | Change From Baseline in pH - Part B | Baseline | 6.22 pH | Standard Deviation 0.879 |
| Part B: SAGE-217 | Change From Baseline in pH - Part B | Change from Baseline at Follow-up Day 42 | -0.42 pH | Standard Deviation 0.962 |
| Part B: SAGE-217 | Change From Baseline in pH - Part B | Baseline | 6.23 pH | Standard Deviation 0.857 |
| Part B: SAGE-217 | Change From Baseline in pH - Part B | Change from Baseline at Day 8 | -0.16 pH | Standard Deviation 1.169 |
| Part B: SAGE-217 | Change From Baseline in pH - Part B | Change from Baseline at Day 15/ET | -0.23 pH | Standard Deviation 0.909 |
| Part B: SAGE-217 | Change From Baseline in pH - Part B | Change from Baseline at Follow-up Day 21 | -0.15 pH | Standard Deviation 0.852 |
| Part B: SAGE-217 | Change From Baseline in pH - Part B | Change from Baseline at Follow-up Day 28 | -0.31 pH | Standard Deviation 1.065 |
| Part B: SAGE-217 | Change From Baseline in pH - Part B | Change from Baseline at Follow-up Day 35 | -0.17 pH | Standard Deviation 0.933 |
Secondary
Change From Baseline in Platelets - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Platelets - Part B | Change from Baseline at Day 15/ET | 6.8 10^9 cells/L | Standard Deviation 39.39 |
| Part A: SAGE-217 | Change From Baseline in Platelets - Part B | Change from Baseline at Follow-up Day 28 | 3.5 10^9 cells/L | Standard Deviation 40.3 |
| Part A: SAGE-217 | Change From Baseline in Platelets - Part B | Change from Baseline at Day 8 | -8.5 10^9 cells/L | Standard Deviation 42.93 |
| Part A: SAGE-217 | Change From Baseline in Platelets - Part B | Change from Baseline at Follow-up Day 35 | -4.9 10^9 cells/L | Standard Deviation 43.23 |
| Part A: SAGE-217 | Change From Baseline in Platelets - Part B | Change from Baseline at Follow-up Day 21 | 4.7 10^9 cells/L | Standard Deviation 32.94 |
| Part A: SAGE-217 | Change From Baseline in Platelets - Part B | Change from Baseline at Follow-up Day 42 | -1.8 10^9 cells/L | Standard Deviation 48.71 |
| Part A: SAGE-217 | Change From Baseline in Platelets - Part B | Baseline | 287.0 10^9 cells/L | Standard Deviation 74.33 |
| Part B: SAGE-217 | Change From Baseline in Platelets - Part B | Change from Baseline at Follow-up Day 42 | -2.7 10^9 cells/L | Standard Deviation 33.61 |
| Part B: SAGE-217 | Change From Baseline in Platelets - Part B | Baseline | 272.2 10^9 cells/L | Standard Deviation 60.08 |
| Part B: SAGE-217 | Change From Baseline in Platelets - Part B | Change from Baseline at Day 8 | -0.9 10^9 cells/L | Standard Deviation 36.43 |
| Part B: SAGE-217 | Change From Baseline in Platelets - Part B | Change from Baseline at Day 15/ET | 3.7 10^9 cells/L | Standard Deviation 36.16 |
| Part B: SAGE-217 | Change From Baseline in Platelets - Part B | Change from Baseline at Follow-up Day 21 | 7.4 10^9 cells/L | Standard Deviation 29.01 |
| Part B: SAGE-217 | Change From Baseline in Platelets - Part B | Change from Baseline at Follow-up Day 28 | 5.0 10^9 cells/L | Standard Deviation 31.48 |
| Part B: SAGE-217 | Change From Baseline in Platelets - Part B | Change from Baseline at Follow-up Day 35 | -1.7 10^9 cells/L | Standard Deviation 31.25 |
Secondary
Change From Baseline in Potassium - Part B
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Potassium - Part B | Change from Baseline at Day 15/ET | 0.05 mmol/L | Standard Deviation 0.402 |
| Part A: SAGE-217 | Change From Baseline in Potassium - Part B | Change from Baseline at Follow-up Day 28 | 0.05 mmol/L | Standard Deviation 0.342 |
| Part A: SAGE-217 | Change From Baseline in Potassium - Part B | Change from Baseline at Day 8 | 0.05 mmol/L | Standard Deviation 0.432 |
| Part A: SAGE-217 | Change From Baseline in Potassium - Part B | Change from Baseline at Follow-up Day 35 | 0.07 mmol/L | Standard Deviation 0.351 |
| Part A: SAGE-217 | Change From Baseline in Potassium - Part B | Change from Baseline at Follow-up Day 21 | 0.01 mmol/L | Standard Deviation 0.371 |
| Part A: SAGE-217 | Change From Baseline in Potassium - Part B | Change from Baseline at Follow-up Day 42 | 0.04 mmol/L | Standard Deviation 0.42 |
| Part A: SAGE-217 | Change From Baseline in Potassium - Part B | Baseline | 4.33 mmol/L | Standard Deviation 0.362 |
| Part B: SAGE-217 | Change From Baseline in Potassium - Part B | Change from Baseline at Follow-up Day 42 | -0.06 mmol/L | Standard Deviation 0.491 |
| Part B: SAGE-217 | Change From Baseline in Potassium - Part B | Baseline | 4.36 mmol/L | Standard Deviation 0.442 |
| Part B: SAGE-217 | Change From Baseline in Potassium - Part B | Change from Baseline at Day 8 | 0.09 mmol/L | Standard Deviation 0.517 |
| Part B: SAGE-217 | Change From Baseline in Potassium - Part B | Change from Baseline at Day 15/ET | 0.03 mmol/L | Standard Deviation 0.408 |
| Part B: SAGE-217 | Change From Baseline in Potassium - Part B | Change from Baseline at Follow-up Day 21 | -0.01 mmol/L | Standard Deviation 0.467 |
| Part B: SAGE-217 | Change From Baseline in Potassium - Part B | Change from Baseline at Follow-up Day 28 | 0.00 mmol/L | Standard Deviation 0.581 |
| Part B: SAGE-217 | Change From Baseline in Potassium - Part B | Change from Baseline at Follow-up Day 35 | -0.04 mmol/L | Standard Deviation 0.468 |
Secondary
Change From Baseline in PR Interval - Part B
ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study.
Time frame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in PR Interval - Part B | Baseline | 149.5 msec |
| Part A: SAGE-217 | Change From Baseline in PR Interval - Part B | Change from Baseline at Day 1 | 1.0 msec |
| Part A: SAGE-217 | Change From Baseline in PR Interval - Part B | Change from Baseline at Day 2 | 1.5 msec |
| Part A: SAGE-217 | Change From Baseline in PR Interval - Part B | Change from Baseline at Day 7 | 3.5 msec |
| Part A: SAGE-217 | Change From Baseline in PR Interval - Part B | Change from Baseline at Day 14 | 4.0 msec |
| Part A: SAGE-217 | Change From Baseline in PR Interval - Part B | Change from Baseline at Follow-up Day 21 | 0.0 msec |
| Part B: SAGE-217 | Change From Baseline in PR Interval - Part B | Change from Baseline at Day 14 | 3.0 msec |
| Part B: SAGE-217 | Change From Baseline in PR Interval - Part B | Baseline | 162.0 msec |
| Part B: SAGE-217 | Change From Baseline in PR Interval - Part B | Change from Baseline at Day 7 | 1.5 msec |
| Part B: SAGE-217 | Change From Baseline in PR Interval - Part B | Change from Baseline at Day 1 | 2.0 msec |
| Part B: SAGE-217 | Change From Baseline in PR Interval - Part B | Change from Baseline at Follow-up Day 21 | 0.5 msec |
| Part B: SAGE-217 | Change From Baseline in PR Interval - Part B | Change from Baseline at Day 2 | 4.0 msec |
Secondary
Change From Baseline in Protein - Part B
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Protein - Part B | Change from Baseline at Day 15/ET | -1.3 g/L | Standard Deviation 4.45 |
| Part A: SAGE-217 | Change From Baseline in Protein - Part B | Change from Baseline at Follow-up Day 28 | -0.9 g/L | Standard Deviation 5.05 |
| Part A: SAGE-217 | Change From Baseline in Protein - Part B | Change from Baseline at Day 8 | -2.1 g/L | Standard Deviation 4.47 |
| Part A: SAGE-217 | Change From Baseline in Protein - Part B | Change from Baseline at Follow-up Day 35 | -1.2 g/L | Standard Deviation 4.61 |
| Part A: SAGE-217 | Change From Baseline in Protein - Part B | Change from Baseline at Follow-up Day 21 | -2.1 g/L | Standard Deviation 4.05 |
| Part A: SAGE-217 | Change From Baseline in Protein - Part B | Change from Baseline at Follow-up Day 42 | -1.4 g/L | Standard Deviation 4.01 |
| Part A: SAGE-217 | Change From Baseline in Protein - Part B | Baseline | 75.0 g/L | Standard Deviation 5.02 |
| Part B: SAGE-217 | Change From Baseline in Protein - Part B | Change from Baseline at Follow-up Day 42 | -2.1 g/L | Standard Deviation 5.73 |
| Part B: SAGE-217 | Change From Baseline in Protein - Part B | Baseline | 76.0 g/L | Standard Deviation 5.9 |
| Part B: SAGE-217 | Change From Baseline in Protein - Part B | Change from Baseline at Day 8 | -1.3 g/L | Standard Deviation 5.47 |
| Part B: SAGE-217 | Change From Baseline in Protein - Part B | Change from Baseline at Day 15/ET | -1.6 g/L | Standard Deviation 5.9 |
| Part B: SAGE-217 | Change From Baseline in Protein - Part B | Change from Baseline at Follow-up Day 21 | -2.5 g/L | Standard Deviation 5.77 |
| Part B: SAGE-217 | Change From Baseline in Protein - Part B | Change from Baseline at Follow-up Day 28 | -1.9 g/L | Standard Deviation 5.58 |
| Part B: SAGE-217 | Change From Baseline in Protein - Part B | Change from Baseline at Follow-up Day 35 | -2.3 g/L | Standard Deviation 5.72 |
Secondary
Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The data for prothrombin international normalized ratio are presented as SI unit, percentage (%).
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B | Change from Baseline at Day 15/ET | -0.003 percentage | Standard Deviation 0.0426 |
| Part A: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B | Change from Baseline at Follow-up Day 28 | -0.007 percentage | Standard Deviation 0.0337 |
| Part A: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B | Baseline | 1.006 percentage | Standard Deviation 0.0394 |
| Part A: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B | Change from Baseline at Follow-up Day 35 | -0.002 percentage | Standard Deviation 0.0439 |
| Part A: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B | Change from Baseline at Follow-up Day 21 | 0.002 percentage | Standard Deviation 0.038 |
| Part A: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B | Change from Baseline at Follow-up Day 42 | 0.002 percentage | Standard Deviation 0.039 |
| Part A: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B | Change from Baseline at Day 8 | 0.011 percentage | Standard Deviation 0.0466 |
| Part B: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B | Change from Baseline at Follow-up Day 42 | 0.003 percentage | Standard Deviation 0.042 |
| Part B: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B | Baseline | 1.032 percentage | Standard Deviation 0.0527 |
| Part B: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B | Change from Baseline at Day 8 | -0.016 percentage | Standard Deviation 0.0436 |
| Part B: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B | Change from Baseline at Day 15/ET | -0.010 percentage | Standard Deviation 0.0628 |
| Part B: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B | Change from Baseline at Follow-up Day 21 | -0.003 percentage | Standard Deviation 0.0372 |
| Part B: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B | Change from Baseline at Follow-up Day 28 | 0.002 percentage | Standard Deviation 0.044 |
| Part B: SAGE-217 | Change From Baseline in Prothrombin International Normalized Ratio (%) - Part B | Change from Baseline at Follow-up Day 35 | -0.005 percentage | Standard Deviation 0.0384 |
Secondary
Change From Baseline in Prothrombin Time - Part B
Coagulation measures included activated partial thromboplastin time, prothrombin international normalized ratio, and prothrombin time. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Prothrombin Time - Part B | Change from Baseline at Day 15/ET | 0.00 sec |
| Part A: SAGE-217 | Change From Baseline in Prothrombin Time - Part B | Change from Baseline at Follow-up Day 28 | -0.10 sec |
| Part A: SAGE-217 | Change From Baseline in Prothrombin Time - Part B | Change from Baseline at Day 8 | 0.00 sec |
| Part A: SAGE-217 | Change From Baseline in Prothrombin Time - Part B | Change from Baseline at Follow-up Day 35 | 0.00 sec |
| Part A: SAGE-217 | Change From Baseline in Prothrombin Time - Part B | Change from Baseline at Follow-up Day 21 | 0.10 sec |
| Part A: SAGE-217 | Change From Baseline in Prothrombin Time - Part B | Change from Baseline at Follow-up Day 42 | 0.10 sec |
| Part A: SAGE-217 | Change From Baseline in Prothrombin Time - Part B | Baseline | 10.40 sec |
| Part B: SAGE-217 | Change From Baseline in Prothrombin Time - Part B | Change from Baseline at Follow-up Day 42 | 0.00 sec |
| Part B: SAGE-217 | Change From Baseline in Prothrombin Time - Part B | Baseline | 10.60 sec |
| Part B: SAGE-217 | Change From Baseline in Prothrombin Time - Part B | Change from Baseline at Day 8 | -0.20 sec |
| Part B: SAGE-217 | Change From Baseline in Prothrombin Time - Part B | Change from Baseline at Day 15/ET | -0.20 sec |
| Part B: SAGE-217 | Change From Baseline in Prothrombin Time - Part B | Change from Baseline at Follow-up Day 21 | -0.10 sec |
| Part B: SAGE-217 | Change From Baseline in Prothrombin Time - Part B | Change from Baseline at Follow-up Day 28 | 0.10 sec |
| Part B: SAGE-217 | Change From Baseline in Prothrombin Time - Part B | Change from Baseline at Follow-up Day 35 | 0.05 sec |
Secondary
Change From Baseline in QRS Duration - Part B
ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study.
Time frame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in QRS Duration - Part B | Change from Baseline at Day 1 | 0.5 msec |
| Part A: SAGE-217 | Change From Baseline in QRS Duration - Part B | Change from Baseline at Day 7 | -0.5 msec |
| Part A: SAGE-217 | Change From Baseline in QRS Duration - Part B | Baseline | 88.0 msec |
| Part A: SAGE-217 | Change From Baseline in QRS Duration - Part B | Change from Baseline at Day 14 | 0.0 msec |
| Part A: SAGE-217 | Change From Baseline in QRS Duration - Part B | Change from Baseline at Day 2 | 1.0 msec |
| Part A: SAGE-217 | Change From Baseline in QRS Duration - Part B | Change from Baseline at Follow-up Day 21 | -0.5 msec |
| Part B: SAGE-217 | Change From Baseline in QRS Duration - Part B | Change from Baseline at Day 2 | 1.0 msec |
| Part B: SAGE-217 | Change From Baseline in QRS Duration - Part B | Baseline | 89.0 msec |
| Part B: SAGE-217 | Change From Baseline in QRS Duration - Part B | Change from Baseline at Day 1 | 0.5 msec |
| Part B: SAGE-217 | Change From Baseline in QRS Duration - Part B | Change from Baseline at Follow-up Day 21 | 0.0 msec |
| Part B: SAGE-217 | Change From Baseline in QRS Duration - Part B | Change from Baseline at Day 7 | -1.5 msec |
| Part B: SAGE-217 | Change From Baseline in QRS Duration - Part B | Change from Baseline at Day 14 | 0.0 msec |
Secondary
Change From Baseline in QTcF Interval - Part B
ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study.
Time frame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in QTcF Interval - Part B | Baseline | 406.0 msec |
| Part A: SAGE-217 | Change From Baseline in QTcF Interval - Part B | Change from Baseline at Day 1 | 0.0 msec |
| Part A: SAGE-217 | Change From Baseline in QTcF Interval - Part B | Change from Baseline at Day 2 | -2.5 msec |
| Part A: SAGE-217 | Change From Baseline in QTcF Interval - Part B | Change from Baseline at Day 7 | -5.0 msec |
| Part A: SAGE-217 | Change From Baseline in QTcF Interval - Part B | Change from Baseline at Day 14 | -8.0 msec |
| Part A: SAGE-217 | Change From Baseline in QTcF Interval - Part B | Change from Baseline at Follow-up Day 21 | -2.0 msec |
| Part B: SAGE-217 | Change From Baseline in QTcF Interval - Part B | Change from Baseline at Day 14 | -3.0 msec |
| Part B: SAGE-217 | Change From Baseline in QTcF Interval - Part B | Baseline | 410.0 msec |
| Part B: SAGE-217 | Change From Baseline in QTcF Interval - Part B | Change from Baseline at Day 7 | -7.5 msec |
| Part B: SAGE-217 | Change From Baseline in QTcF Interval - Part B | Change from Baseline at Day 1 | -2.0 msec |
| Part B: SAGE-217 | Change From Baseline in QTcF Interval - Part B | Change from Baseline at Follow-up Day 21 | 0.5 msec |
| Part B: SAGE-217 | Change From Baseline in QTcF Interval - Part B | Change from Baseline at Day 2 | -4.0 msec |
Secondary
Change From Baseline in QT Interval - Part B
ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study.
Time frame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in QT Interval - Part B | Baseline | 403.5 msec |
| Part A: SAGE-217 | Change From Baseline in QT Interval - Part B | Change from Baseline at Day 1 | -9.0 msec |
| Part A: SAGE-217 | Change From Baseline in QT Interval - Part B | Change from Baseline at Day 2 | -12.0 msec |
| Part A: SAGE-217 | Change From Baseline in QT Interval - Part B | Change from Baseline at Day 7 | -22.0 msec |
| Part A: SAGE-217 | Change From Baseline in QT Interval - Part B | Change from Baseline at Day 14 | -23.0 msec |
| Part A: SAGE-217 | Change From Baseline in QT Interval - Part B | Change from Baseline at Follow-up Day 21 | -12.5 msec |
| Part B: SAGE-217 | Change From Baseline in QT Interval - Part B | Change from Baseline at Day 14 | -25.5 msec |
| Part B: SAGE-217 | Change From Baseline in QT Interval - Part B | Baseline | 398.0 msec |
| Part B: SAGE-217 | Change From Baseline in QT Interval - Part B | Change from Baseline at Day 7 | -25.5 msec |
| Part B: SAGE-217 | Change From Baseline in QT Interval - Part B | Change from Baseline at Day 1 | -7.0 msec |
| Part B: SAGE-217 | Change From Baseline in QT Interval - Part B | Change from Baseline at Follow-up Day 21 | -7.5 msec |
| Part B: SAGE-217 | Change From Baseline in QT Interval - Part B | Change from Baseline at Day 2 | -15.0 msec |
Secondary
Change From Baseline in Reticulocytes - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET
Population: The safety set included all participants who received at least one dose of the study drug. Overall number of participants analyzed: Number of participants analyzed in this outcome measure. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Reticulocytes - Part B | Baseline | 32.313 10^9 cells/L | Standard Deviation 19.0547 |
| Part A: SAGE-217 | Change From Baseline in Reticulocytes - Part B | Change from Baseline at Day 8 | -19.035 10^9 cells/L | Standard Deviation 12.9613 |
| Part A: SAGE-217 | Change From Baseline in Reticulocytes - Part B | Change from Baseline at Day 15/ET | 9.240 10^9 cells/L | — |
| Part B: SAGE-217 | Change From Baseline in Reticulocytes - Part B | Baseline | 78.735 10^9 cells/L | Standard Deviation 58.5272 |
Secondary
Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B
Hematology measures included basophils, basophils to leukocytes ratio, eosinophils, eosinophils to leukocytes ratio, hematocrit, hemoglobin, lymphocytes, lymphocytes to leukocytes ratio, monocytes, monocytes to leukocytes ratio, neutrophils, neutrophils to leukocytes ratio, platelets, erythrocytes, reticulocytes, reticulocytes to erythrocytes ratio and leukocytes. The analysis was performed in participants included in Part B of the study. ET = Early Termination. The blood cell differential (ratio) data are presented as SI unit, percentage (%).
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B | Change from Baseline at Day 15/ET | -0.03 percentage | Standard Deviation 0.31 |
| Part A: SAGE-217 | Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 28 | 0.17 percentage | Standard Deviation 0.289 |
| Part A: SAGE-217 | Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B | Change from Baseline at Day 8 | -0.02 percentage | Standard Deviation 0.29 |
| Part A: SAGE-217 | Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 35 | 0.15 percentage | Standard Deviation 0.254 |
| Part A: SAGE-217 | Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 21 | 0.14 percentage | Standard Deviation 0.352 |
| Part A: SAGE-217 | Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 42 | 0.12 percentage | Standard Deviation 0.227 |
| Part A: SAGE-217 | Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B | Baseline | 1.32 percentage | Standard Deviation 0.36 |
| Part B: SAGE-217 | Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 42 | 0.03 percentage | Standard Deviation 0.312 |
| Part B: SAGE-217 | Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B | Baseline | 1.40 percentage | Standard Deviation 0.517 |
| Part B: SAGE-217 | Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B | Change from Baseline at Day 8 | -0.07 percentage | Standard Deviation 0.363 |
| Part B: SAGE-217 | Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B | Change from Baseline at Day 15/ET | 0.00 percentage | Standard Deviation 0.372 |
| Part B: SAGE-217 | Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 21 | 0.05 percentage | Standard Deviation 0.359 |
| Part B: SAGE-217 | Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 28 | 0.03 percentage | Standard Deviation 0.296 |
| Part B: SAGE-217 | Change From Baseline in Reticulocytes to Erythrocytes Ratio (%) - Part B | Change from Baseline at Follow-up Day 35 | 0.07 percentage | Standard Deviation 0.32 |
Secondary
Change From Baseline in RR Interval - Part B
ECG measures included QT interval, QTcF interval, ECG mean heart rate, RR interval, PR interval, and QRS duration. The analysis was performed in participants included in Part B of the study.
Time frame: Baseline, Days 1, 2, 7, 14 and follow-up Day 21
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in RR Interval - Part B | Baseline | 952.0 msec |
| Part A: SAGE-217 | Change From Baseline in RR Interval - Part B | Change from Baseline at Day 1 | -50.0 msec |
| Part A: SAGE-217 | Change From Baseline in RR Interval - Part B | Change from Baseline at Day 2 | -46.0 msec |
| Part A: SAGE-217 | Change From Baseline in RR Interval - Part B | Change from Baseline at Day 7 | -115.5 msec |
| Part A: SAGE-217 | Change From Baseline in RR Interval - Part B | Change from Baseline at Day 14 | -111.0 msec |
| Part A: SAGE-217 | Change From Baseline in RR Interval - Part B | Change from Baseline at Follow-up Day 21 | -68.5 msec |
| Part B: SAGE-217 | Change From Baseline in RR Interval - Part B | Change from Baseline at Day 14 | -142.0 msec |
| Part B: SAGE-217 | Change From Baseline in RR Interval - Part B | Baseline | 938.0 msec |
| Part B: SAGE-217 | Change From Baseline in RR Interval - Part B | Change from Baseline at Day 7 | -92.0 msec |
| Part B: SAGE-217 | Change From Baseline in RR Interval - Part B | Change from Baseline at Day 1 | -52.5 msec |
| Part B: SAGE-217 | Change From Baseline in RR Interval - Part B | Change from Baseline at Follow-up Day 21 | -32.0 msec |
| Part B: SAGE-217 | Change From Baseline in RR Interval - Part B | Change from Baseline at Day 2 | -51.0 msec |
Secondary
Change From Baseline in Sodium - Part B
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Sodium - Part B | Change from Baseline at Day 15/ET | -0.6 mmol/L | Standard Deviation 1.94 |
| Part A: SAGE-217 | Change From Baseline in Sodium - Part B | Change from Baseline at Follow-up Day 28 | -0.1 mmol/L | Standard Deviation 2.14 |
| Part A: SAGE-217 | Change From Baseline in Sodium - Part B | Change from Baseline at Day 8 | -0.7 mmol/L | Standard Deviation 1.74 |
| Part A: SAGE-217 | Change From Baseline in Sodium - Part B | Change from Baseline at Follow-up Day 35 | -0.8 mmol/L | Standard Deviation 2.2 |
| Part A: SAGE-217 | Change From Baseline in Sodium - Part B | Change from Baseline at Follow-up Day 21 | 0.3 mmol/L | Standard Deviation 2 |
| Part A: SAGE-217 | Change From Baseline in Sodium - Part B | Change from Baseline at Follow-up Day 42 | -0.6 mmol/L | Standard Deviation 2.1 |
| Part A: SAGE-217 | Change From Baseline in Sodium - Part B | Baseline | 140.8 mmol/L | Standard Deviation 1.78 |
| Part B: SAGE-217 | Change From Baseline in Sodium - Part B | Change from Baseline at Follow-up Day 42 | -0.1 mmol/L | Standard Deviation 2.28 |
| Part B: SAGE-217 | Change From Baseline in Sodium - Part B | Baseline | 140.5 mmol/L | Standard Deviation 1.82 |
| Part B: SAGE-217 | Change From Baseline in Sodium - Part B | Change from Baseline at Day 8 | 0.1 mmol/L | Standard Deviation 2.08 |
| Part B: SAGE-217 | Change From Baseline in Sodium - Part B | Change from Baseline at Day 15/ET | 0.0 mmol/L | Standard Deviation 2.6 |
| Part B: SAGE-217 | Change From Baseline in Sodium - Part B | Change from Baseline at Follow-up Day 21 | 0.0 mmol/L | Standard Deviation 2.33 |
| Part B: SAGE-217 | Change From Baseline in Sodium - Part B | Change from Baseline at Follow-up Day 28 | -0.1 mmol/L | Standard Deviation 2.68 |
| Part B: SAGE-217 | Change From Baseline in Sodium - Part B | Change from Baseline at Follow-up Day 35 | 0.3 mmol/L | Standard Deviation 2.26 |
Secondary
Change From Baseline in Specific Gravity - Part B
Urinalysis measures included pH and specific gravity. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Specific Gravity - Part B | Change from Baseline at Day 15/ET | 0.003 ratio | Standard Deviation 0.0092 |
| Part A: SAGE-217 | Change From Baseline in Specific Gravity - Part B | Change from Baseline at Follow-up Day 28 | 0.004 ratio | Standard Deviation 0.0093 |
| Part A: SAGE-217 | Change From Baseline in Specific Gravity - Part B | Change from Baseline at Day 8 | 0.002 ratio | Standard Deviation 0.0092 |
| Part A: SAGE-217 | Change From Baseline in Specific Gravity - Part B | Change from Baseline at Follow-up Day 35 | 0.001 ratio | Standard Deviation 0.0096 |
| Part A: SAGE-217 | Change From Baseline in Specific Gravity - Part B | Change from Baseline at Follow-up Day 21 | 0.003 ratio | Standard Deviation 0.0101 |
| Part A: SAGE-217 | Change From Baseline in Specific Gravity - Part B | Change from Baseline at Follow-up Day 42 | 0.004 ratio | Standard Deviation 0.0086 |
| Part A: SAGE-217 | Change From Baseline in Specific Gravity - Part B | Baseline | 1.016 ratio | Standard Deviation 0.0086 |
| Part B: SAGE-217 | Change From Baseline in Specific Gravity - Part B | Change from Baseline at Follow-up Day 42 | 0.002 ratio | Standard Deviation 0.0112 |
| Part B: SAGE-217 | Change From Baseline in Specific Gravity - Part B | Baseline | 1.018 ratio | Standard Deviation 0.0092 |
| Part B: SAGE-217 | Change From Baseline in Specific Gravity - Part B | Change from Baseline at Day 8 | 0.000 ratio | Standard Deviation 0.009 |
| Part B: SAGE-217 | Change From Baseline in Specific Gravity - Part B | Change from Baseline at Day 15/ET | -0.001 ratio | Standard Deviation 0.0106 |
| Part B: SAGE-217 | Change From Baseline in Specific Gravity - Part B | Change from Baseline at Follow-up Day 21 | 0.000 ratio | Standard Deviation 0.0094 |
| Part B: SAGE-217 | Change From Baseline in Specific Gravity - Part B | Change from Baseline at Follow-up Day 28 | 0.002 ratio | Standard Deviation 0.0087 |
| Part B: SAGE-217 | Change From Baseline in Specific Gravity - Part B | Change from Baseline at Follow-up Day 35 | 0.001 ratio | Standard Deviation 0.0099 |
Secondary
Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B
The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study.
Time frame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21, 28, 35 and 42
Population: The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 2 | -3.5 score on a scale | Standard Error 0.98 |
| Part A: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 3 | -5.2 score on a scale | Standard Error 1.09 |
| Part A: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 4 | -7.7 score on a scale | Standard Error 1.13 |
| Part A: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 5 | -8.5 score on a scale | Standard Error 1.19 |
| Part A: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 6 | -9.1 score on a scale | Standard Error 1.21 |
| Part A: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 7 | -9.2 score on a scale | Standard Error 1.29 |
| Part A: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 8 | -11.0 score on a scale | Standard Error 1.29 |
| Part A: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 15 | -10.3 score on a scale | Standard Error 1.33 |
| Part A: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 21 | -11.3 score on a scale | Standard Error 1.43 |
| Part A: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 28 | -11.3 score on a scale | Standard Error 1.44 |
| Part A: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 35 | -12.6 score on a scale | Standard Error 1.49 |
| Part A: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 42 | -12.3 score on a scale | Standard Error 1.49 |
| Part B: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 35 | -14.9 score on a scale | Standard Error 1.47 |
| Part B: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 2 | -5.8 score on a scale | Standard Error 0.97 |
| Part B: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 8 | -14.4 score on a scale | Standard Error 1.27 |
| Part B: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 3 | -9.3 score on a scale | Standard Error 1.07 |
| Part B: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 28 | -15.4 score on a scale | Standard Error 1.41 |
| Part B: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 4 | -10.6 score on a scale | Standard Error 1.11 |
| Part B: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 15 | -17.4 score on a scale | Standard Error 1.31 |
| Part B: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 5 | -12.3 score on a scale | Standard Error 1.17 |
| Part B: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 42 | -14.6 score on a scale | Standard Error 1.46 |
| Part B: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 6 | -13.6 score on a scale | Standard Error 1.19 |
| Part B: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 21 | -16.3 score on a scale | Standard Error 1.4 |
| Part B: SAGE-217 | Change From Baseline in the 17-item HAM-D Total Score at All Time Points - Part B | Change from Baseline at Day 7 | -13.7 score on a scale | Standard Error 1.27 |
Comparison: Day 2p-value: 0.022395% CI: [-4.3, -0.3]Mixed Effect Model for Repeated Measures
Comparison: Day 3p-value: 0.00195% CI: [-6.4, -1.7]Mixed Effect Model for Repeated Measures
Comparison: Day 4p-value: 0.023395% CI: [-5.5, -0.4]Mixed Effect Model for Repeated Measures
Comparison: Day 5p-value: 0.006695% CI: [-6.6, -1.1]Mixed Effect Model for Repeated Measures
Comparison: Day 6p-value: 0.001995% CI: [-7.3, -1.7]Mixed Effect Model for Repeated Measures
Comparison: Day 7p-value: 0.004395% CI: [-7.6, -1.5]Mixed Effect Model for Repeated Measures
Comparison: Day 8p-value: 0.031895% CI: [-6.4, -0.3]Mixed Effect Model for Repeated Measures
Comparison: Day 15p-value: <0.000195% CI: [-10.2, -3.9]Mixed Effect Model for Repeated Measures
Comparison: Day 21p-value: 0.006495% CI: [-8.4, -1.4]Mixed Effect Model for Repeated Measures
Comparison: Day 28p-value: 0.024395% CI: [-7.6, -0.5]Mixed Effect Model for Repeated Measures
Comparison: Day 35p-value: 0.228595% CI: [-6, 1.4]Mixed Effect Model for Repeated Measures
Comparison: Day 42p-value: 0.21295% CI: [-6, 1.4]Mixed Effect Model for Repeated Measures
Secondary
Change From Baseline in the HAM-D Total Score at Day 15 and All Other Time Points - Part A
The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicate a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of the study.
Time frame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28
Population: The efficacy set included all participants who received at least one dose of the study drug and had a baseline and at least one postbaseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in the HAM-D Total Score at Day 15 and All Other Time Points - Part A | Baseline | 27.2 score on a scale | Standard Deviation 3.06 |
| Part A: SAGE-217 | Change From Baseline in the HAM-D Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 2 | -5.9 score on a scale | Standard Deviation 4.44 |
| Part A: SAGE-217 | Change From Baseline in the HAM-D Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 3 | -9.1 score on a scale | Standard Deviation 4.82 |
| Part A: SAGE-217 | Change From Baseline in the HAM-D Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 4 | -12.4 score on a scale | Standard Deviation 5.74 |
| Part A: SAGE-217 | Change From Baseline in the HAM-D Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 5 | -14.4 score on a scale | Standard Deviation 5.68 |
| Part A: SAGE-217 | Change From Baseline in the HAM-D Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 6 | -16.0 score on a scale | Standard Deviation 5.48 |
| Part A: SAGE-217 | Change From Baseline in the HAM-D Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 7 | -16.2 score on a scale | Standard Deviation 6.01 |
| Part A: SAGE-217 | Change From Baseline in the HAM-D Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 8 | -18.2 score on a scale | Standard Deviation 5.94 |
| Part A: SAGE-217 | Change From Baseline in the HAM-D Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 15 | -19.9 score on a scale | Standard Deviation 5.78 |
| Part A: SAGE-217 | Change From Baseline in the HAM-D Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 21 | -20.5 score on a scale | Standard Deviation 7.11 |
| Part A: SAGE-217 | Change From Baseline in the HAM-D Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 28 | -19.7 score on a scale | Standard Deviation 8.09 |
Secondary
Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B
The MADRS was a ten-item diagnostic questionnaire which psychiatrists used to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicated more severe depression. A negative change from baseline indicated less severe depression. A positive change from baseline indicated more severe depression. The analysis was performed in participants included in Part B of the study.
Time frame: Baseline, Days 2, 8, 15, 21, 28, 35 and 42
Population: The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 15 | -15.0 score on a scale | Standard Error 1.94 |
| Part A: SAGE-217 | Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 28 | -14.8 score on a scale | Standard Error 2.14 |
| Part A: SAGE-217 | Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 8 | -15.4 score on a scale | Standard Error 1.9 |
| Part A: SAGE-217 | Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 35 | -16.4 score on a scale | Standard Error 2.25 |
| Part A: SAGE-217 | Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 21 | -15.2 score on a scale | Standard Error 2.14 |
| Part A: SAGE-217 | Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 42 | -17.2 score on a scale | Standard Error 2.15 |
| Part A: SAGE-217 | Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 2 | -4.5 score on a scale | Standard Error 1.36 |
| Part B: SAGE-217 | Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 42 | -19.1 score on a scale | Standard Error 2.11 |
| Part B: SAGE-217 | Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 2 | -6.9 score on a scale | Standard Error 1.35 |
| Part B: SAGE-217 | Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 8 | -19.4 score on a scale | Standard Error 1.88 |
| Part B: SAGE-217 | Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 15 | -22.5 score on a scale | Standard Error 1.92 |
| Part B: SAGE-217 | Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 21 | -21.9 score on a scale | Standard Error 2.11 |
| Part B: SAGE-217 | Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 28 | -20.1 score on a scale | Standard Error 2.11 |
| Part B: SAGE-217 | Change From Baseline in the MADRS Total Score at Day 15 and All Other Time Points - Part B | Change from Baseline at Day 35 | -19.4 score on a scale | Standard Error 2.23 |
Comparison: Day 2p-value: 0.083695% CI: [-5.1, 0.3]Mixed Effect Model for Repeated Measures
Comparison: Day 8p-value: 0.086495% CI: [-8.6, 0.6]Mixed Effect Model for Repeated Measures
Comparison: Day 15p-value: 0.002195% CI: [-12.3, -2.8]Mixed Effect Model for Repeated Measures
Comparison: Day 21p-value: 0.015795% CI: [-12, -1.3]Mixed Effect Model for Repeated Measures
Comparison: Day 28p-value: 0.053395% CI: [-10.6, 0.1]Mixed Effect Model for Repeated Measures
Comparison: Day 35p-value: 0.287895% CI: [-8.8, 2.6]Mixed Effect Model for Repeated Measures
Comparison: Day 42p-value: 0.466495% CI: [-7.4, 3.4]Mixed Effect Model for Repeated Measures
Secondary
Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part A
The MADRS was a ten-item diagnostic questionnaire which psychiatrists used to measure the severity of depressive episodes in participants with mood disorders. It was designed as an adjunct to the HAM-D, to be more sensitive than the Hamilton Scale to the changes brought on by antidepressants and other forms of treatment. Each item yielded a score of 0 to 6. The MADRS total score was calculated as the sum of the 10 individual item scores, which ranged from 0 to 60. Higher MADRS scores indicated more severe depression. A negative change from baseline indicated less severe depression. A positive change from baseline indicated more severe depression. The analysis was performed in participants included in Part A of the study.
Time frame: Baseline, Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28
Population: The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 2 | -6.4 score on a scale | Standard Deviation 5.72 |
| Part A: SAGE-217 | Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part A | Baseline | 36.9 score on a scale | Standard Deviation 5.22 |
| Part A: SAGE-217 | Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 3 | -9.6 score on a scale | Standard Deviation 7.05 |
| Part A: SAGE-217 | Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 4 | -14.2 score on a scale | Standard Deviation 8.85 |
| Part A: SAGE-217 | Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 5 | -16.2 score on a scale | Standard Deviation 9.38 |
| Part A: SAGE-217 | Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 6 | -18.9 score on a scale | Standard Deviation 9.84 |
| Part A: SAGE-217 | Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 7 | -19.3 score on a scale | Standard Deviation 9.28 |
| Part A: SAGE-217 | Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 8 | -22.8 score on a scale | Standard Deviation 9.71 |
| Part A: SAGE-217 | Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 15 | -26.4 score on a scale | Standard Deviation 9.3 |
| Part A: SAGE-217 | Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 21 | -26.1 score on a scale | Standard Deviation 11.15 |
| Part A: SAGE-217 | Change From Baseline in the Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score at Day 15 and All Other Time Points - Part A | Change from Baseline at Day 28 | -25.0 score on a scale | Standard Deviation 12.77 |
Secondary
Change From Baseline in Thyrotropin - Part B
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Thyrotropin - Part B | Change from Baseline at Day 15/ET | 0.668 milli-international units per liter | Standard Deviation 1.5106 |
| Part A: SAGE-217 | Change From Baseline in Thyrotropin - Part B | Change from Baseline at Follow-up Day 28 | 0.218 milli-international units per liter | Standard Deviation 0.8047 |
| Part A: SAGE-217 | Change From Baseline in Thyrotropin - Part B | Change from Baseline at Day 8 | 0.464 milli-international units per liter | Standard Deviation 0.8096 |
| Part A: SAGE-217 | Change From Baseline in Thyrotropin - Part B | Change from Baseline at Follow-up Day 35 | 0.156 milli-international units per liter | Standard Deviation 0.7314 |
| Part A: SAGE-217 | Change From Baseline in Thyrotropin - Part B | Change from Baseline at Follow-up Day 21 | -0.011 milli-international units per liter | Standard Deviation 0.7579 |
| Part A: SAGE-217 | Change From Baseline in Thyrotropin - Part B | Change from Baseline at Follow-up Day 42 | 0.156 milli-international units per liter | Standard Deviation 1.052 |
| Part A: SAGE-217 | Change From Baseline in Thyrotropin - Part B | Baseline | 1.328 milli-international units per liter | Standard Deviation 0.7996 |
| Part B: SAGE-217 | Change From Baseline in Thyrotropin - Part B | Change from Baseline at Follow-up Day 42 | 0.124 milli-international units per liter | Standard Deviation 0.553 |
| Part B: SAGE-217 | Change From Baseline in Thyrotropin - Part B | Baseline | 1.398 milli-international units per liter | Standard Deviation 0.9451 |
| Part B: SAGE-217 | Change From Baseline in Thyrotropin - Part B | Change from Baseline at Day 8 | 0.445 milli-international units per liter | Standard Deviation 0.7181 |
| Part B: SAGE-217 | Change From Baseline in Thyrotropin - Part B | Change from Baseline at Day 15/ET | 0.315 milli-international units per liter | Standard Deviation 0.6782 |
| Part B: SAGE-217 | Change From Baseline in Thyrotropin - Part B | Change from Baseline at Follow-up Day 21 | -0.014 milli-international units per liter | Standard Deviation 0.7316 |
| Part B: SAGE-217 | Change From Baseline in Thyrotropin - Part B | Change from Baseline at Follow-up Day 28 | 0.099 milli-international units per liter | Standard Deviation 0.6297 |
| Part B: SAGE-217 | Change From Baseline in Thyrotropin - Part B | Change from Baseline at Follow-up Day 35 | 0.103 milli-international units per liter | Standard Deviation 0.5723 |
Secondary
Change From Baseline in Urea Nitrogen - Part B
Clinical chemistry measures included albumin, alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, bilirubin, calcium, chloride, carbon dioxide, creatinine, glucose, potassium, magnesium, phosphate, protein, sodium, thyrotropin, and urea nitrogen. The analysis was performed in participants included in Part B of the study. ET = Early Termination.
Time frame: Baseline, Day 8, Day 15/ET, follow-up Days 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 | Change From Baseline in Urea Nitrogen - Part B | Change from Baseline at Day 15/ET | 0.330 mmol/L | Standard Deviation 1.2817 |
| Part A: SAGE-217 | Change From Baseline in Urea Nitrogen - Part B | Change from Baseline at Follow-up Day 28 | 0.057 mmol/L | Standard Deviation 1.2372 |
| Part A: SAGE-217 | Change From Baseline in Urea Nitrogen - Part B | Change from Baseline at Day 8 | 0.322 mmol/L | Standard Deviation 1.0179 |
| Part A: SAGE-217 | Change From Baseline in Urea Nitrogen - Part B | Change from Baseline at Follow-up Day 35 | 0.138 mmol/L | Standard Deviation 1.0796 |
| Part A: SAGE-217 | Change From Baseline in Urea Nitrogen - Part B | Change from Baseline at Follow-up Day 21 | -0.096 mmol/L | Standard Deviation 1.1059 |
| Part A: SAGE-217 | Change From Baseline in Urea Nitrogen - Part B | Change from Baseline at Follow-up Day 42 | 0.057 mmol/L | Standard Deviation 1.2051 |
| Part A: SAGE-217 | Change From Baseline in Urea Nitrogen - Part B | Baseline | 4.186 mmol/L | Standard Deviation 1.4151 |
| Part B: SAGE-217 | Change From Baseline in Urea Nitrogen - Part B | Change from Baseline at Follow-up Day 42 | -0.275 mmol/L | Standard Deviation 1.1708 |
| Part B: SAGE-217 | Change From Baseline in Urea Nitrogen - Part B | Baseline | 4.644 mmol/L | Standard Deviation 2.0582 |
| Part B: SAGE-217 | Change From Baseline in Urea Nitrogen - Part B | Change from Baseline at Day 8 | 0.334 mmol/L | Standard Deviation 1.6435 |
| Part B: SAGE-217 | Change From Baseline in Urea Nitrogen - Part B | Change from Baseline at Day 15/ET | 0.189 mmol/L | Standard Deviation 1.686 |
| Part B: SAGE-217 | Change From Baseline in Urea Nitrogen - Part B | Change from Baseline at Follow-up Day 21 | 0.196 mmol/L | Standard Deviation 1.0191 |
| Part B: SAGE-217 | Change From Baseline in Urea Nitrogen - Part B | Change from Baseline at Follow-up Day 28 | 0.186 mmol/L | Standard Deviation 1.0919 |
| Part B: SAGE-217 | Change From Baseline in Urea Nitrogen - Part B | Change from Baseline at Follow-up Day 35 | 0.078 mmol/L | Standard Deviation 1.4422 |
Secondary
Percentage of Participants With AEs During Post-TEAE Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. TEAE was defined as an adverse event with onset after the start of study drug, or any worsening of a pre-existing medical condition/adverse event with onset after the start of study drug and until 7 days after the last dose. Post-TEAE period was defined as 7 days after final dose through last follow-up (Day 42). The analysis was performed in participants included in Part B of the study.
Time frame: Day 21 up to Day 42
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: SAGE-217 | Percentage of Participants With AEs During Post-TEAE Period | 22.7 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With AEs During Post-TEAE Period | 8.9 percentage of participants |
Secondary
Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B
The C-SSRS scale consisted of a baseline evaluation (at screening) that assessed the lifetime experience of participants with suicidal ideation and behavior and a postbaseline evaluation that focused on suicidality since the last study visit. The C-SSRS included yes or no' responses for assessment of suicidal ideation and behavior as well as numeric ratings for severity of ideation, if present (from 1 to 5, with 5 being the most severe). The C-SSRS SI items involved wish to be dead, non-specific active suicidal thoughts, active SI with any methods, active SI with some intent and active SI with specific plan. The analysis was performed in participants included in Part B of the study. SCLR = screening: lifetime recall.
Time frame: Screening, Days 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 15, 21, 28, 35 and 42
Population: The safety set included all participants who received at least one dose of the study drug. Number analyzed: Number of participants in the safety set with a non-missing value at the visit within each treatment group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 6: Wish to be Dead | 2.3 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | SCLR: Active SI with Any Methods | 1 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 7: Wish to be Dead | 2.3 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 2: Wish to be Dead | 2.3 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 8: Wish to be Dead | 2.4 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | SCLR: Wish to be Dead | 11 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 9: Wish to be Dead | 2.4 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | SCLR: Non-specific Active Suicidal Thoughts | 3 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 11: Wish to be Dead | 2.4 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 3: Wish to be Dead | 2.3 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 12: Wish to be Dead | 2.4 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | SCLR: Active SI with Some Intent | 1 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 13: Wish to be Dead | 2.5 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 4: Wish to be Dead | 2.3 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 15: Wish to be Dead | 2.4 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 42: Wish to be Dead | 2.6 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 21: Wish to be Dead | 2.6 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 5: Wish to be Dead | 2.3 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 28: Wish to be Dead | 2.6 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 1: Wish to be Dead | 9.1 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 35: Wish to be Dead | 2.5 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 8: Wish to be Dead | 0 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | SCLR: Wish to be Dead | 8 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | SCLR: Non-specific Active Suicidal Thoughts | 0 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 35: Wish to be Dead | 0 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 42: Wish to be Dead | 0 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | SCLR: Active SI with Any Methods | 0 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | SCLR: Active SI with Some Intent | 0 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 1: Wish to be Dead | 2.2 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 2: Wish to be Dead | 2.2 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 3: Wish to be Dead | 2.2 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 4: Wish to be Dead | 2.2 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 5: Wish to be Dead | 2.2 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 6: Wish to be Dead | 2.2 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 7: Wish to be Dead | 0 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 9: Wish to be Dead | 0 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 11: Wish to be Dead | 0 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 12: Wish to be Dead | 0 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 13: Wish to be Dead | 0 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 15: Wish to be Dead | 0 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 21: Wish to be Dead | 0 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With a Response of Yes to Any C-SSRS Suicidal Ideation (SI) Item - Part B | Day 28: Wish to be Dead | 0 percentage of participants |
Secondary
Percentage of Participants With CGI-I Response - Part B
The CGI-I item employed a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions. CGI-I response was defined as having a score of 1 (very much improved) or 2 (much improved). The analysis was performed in participants included in Part B of the study. Data is reported for participants who had CGI-I response.
Time frame: Days 2, 8, 15, 21, 28, 35 and 42
Population: The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. Number analyzed: Number of participants in efficacy set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: SAGE-217 | Percentage of Participants With CGI-I Response - Part B | Day 8 | 45.2 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With CGI-I Response - Part B | Day 28 | 46.2 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With CGI-I Response - Part B | Day 15 | 45.2 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With CGI-I Response - Part B | Day 35 | 55.0 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With CGI-I Response - Part B | Day 2 | 0 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With CGI-I Response - Part B | Day 42 | 59.0 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With CGI-I Response - Part B | Day 21 | 50.0 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With CGI-I Response - Part B | Day 42 | 69.0 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With CGI-I Response - Part B | Day 2 | 15.6 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With CGI-I Response - Part B | Day 15 | 78.6 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With CGI-I Response - Part B | Day 21 | 71.4 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With CGI-I Response - Part B | Day 28 | 66.7 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With CGI-I Response - Part B | Day 35 | 63.4 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With CGI-I Response - Part B | Day 8 | 70.5 percentage of participants |
Comparison: Day 8p-value: 0.004895% CI: [1.7, 17.9]Generalized Estimating Equation
Comparison: Day 15p-value: 0.000795% CI: [2.5, 29.5]Generalized Estimating Equation
Comparison: Day 21p-value: 0.011395% CI: [1.4, 13.6]Generalized Estimating Equation
Comparison: Day 28p-value: 0.022795% CI: [1.2, 12.8]Generalized Estimating Equation
Comparison: Day 35p-value: 0.151695% CI: [0.7, 7.2]Generalized Estimating Equation
Comparison: Day 42p-value: 0.079395% CI: [0.9, 8.3]Generalized Estimating Equation
Secondary
Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response - Part A
The CGI-I item employed a 7-point Likert scale to measure the overall improvement in the participant's condition post-treatment. The investigator rated the participant's total improvement whether or not it was due entirely to drug treatment. Response choices included: 0 = not assessed, 1 = very much improved, 2 = much improved, 3 = minimally improved, 4 = no change, 5 = minimally worse, 6 = much worse, and 7 = very much worse. The CGI-I was only rated at post-treatment assessments. By definition, all CGI-I assessments were evaluated against baseline conditions. CGI-I response was defined as having a CGI-I global improvement score of 1 (very much improved) or 2 (much improved). The analysis was performed in participants included in Part A of the study. Data is reported for participants who had CGI-I response.
Time frame: Days 2, 3, 8, 15, 21 and 28
Population: The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: SAGE-217 | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response - Part A | Day 2 | 7.7 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response - Part A | Day 3 | 15.4 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response - Part A | Day 8 | 84.6 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response - Part A | Day 15 | 92.3 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response - Part A | Day 21 | 84.6 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response - Part A | Day 28 | 76.9 percentage of participants |
Secondary
Percentage of Participants With HAM-D Remission - Part A
HAM-D remission was defined as having a HAM-D total score of ≤7. The HAM-D total score comprised a sum of the 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of the study.
Time frame: Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28
Population: The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: SAGE-217 | Percentage of Participants With HAM-D Remission - Part A | Day 15 | 61.5 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Remission - Part A | Day 2 | 0 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Remission - Part A | Day 3 | 0 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Remission - Part A | Day 4 | 15.4 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Remission - Part A | Day 5 | 15.4 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Remission - Part A | Day 6 | 38.5 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Remission - Part A | Day 7 | 38.5 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Remission - Part A | Day 8 | 46.2 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Remission - Part A | Day 21 | 69.2 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Remission - Part A | Day 28 | 69.2 percentage of participants |
Secondary
Percentage of Participants With HAM-D Remission - Part B
HAM-D remission was defined as having a HAM-D total score of ≤7. The HAM-D total score comprised a sum of the 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study.
Time frame: Days 2, 8, 15, 21, 28, 35 and 42
Population: The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. Number analyzed: Number of participants in efficacy set with a non-missing value at both baseline and the visit within each treatment group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: SAGE-217 | Percentage of Participants With HAM-D Remission - Part B | Day 2 | 0 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Remission - Part B | Day 28 | 28.2 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Remission - Part B | Day 15 | 26.2 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Remission - Part B | Day 35 | 35.0 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Remission - Part B | Day 8 | 28.6 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Remission - Part B | Day 42 | 33.3 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Remission - Part B | Day 21 | 26.3 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With HAM-D Remission - Part B | Day 42 | 45.2 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With HAM-D Remission - Part B | Day 8 | 36.4 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With HAM-D Remission - Part B | Day 15 | 64.3 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With HAM-D Remission - Part B | Day 21 | 52.4 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With HAM-D Remission - Part B | Day 28 | 52.4 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With HAM-D Remission - Part B | Day 35 | 43.9 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With HAM-D Remission - Part B | Day 2 | 2.2 percentage of participants |
Comparison: Day 8p-value: 0.4395% CI: [0.6, 3.7]Generalized Estimating Equation
Comparison: Day 15p-value: 0.000595% CI: [2.1, 13.3]Generalized Estimating Equation
Comparison: Day 21p-value: 0.017295% CI: [1.2, 8]Generalized Estimating Equation
Comparison: Day 28p-value: 0.022195% CI: [1.2, 7.3]Generalized Estimating Equation
Comparison: Day 35p-value: 0.413995% CI: [0.6, 3.5]Generalized Estimating Equation
Comparison: Day 42p-value: 0.233295% CI: [0.7, 4.3]Generalized Estimating Equation
Secondary
Percentage of Participants With HAM-D Response - Part A
HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score. The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicate a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part A of the study. Data is reported for participants who had HAM-D response.
Time frame: Days 2, 3, 4, 5, 6, 7, 8, 15, 21 and 28
Population: The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: SAGE-217 | Percentage of Participants With HAM-D Response - Part A | Day 4 | 30.8 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Response - Part A | Day 5 | 53.8 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Response - Part A | Day 7 | 61.5 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Response - Part A | Day 8 | 84.6 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Response - Part A | Day 28 | 76.9 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Response - Part A | Day 15 | 84.6 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Response - Part A | Day 21 | 76.9 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Response - Part A | Day 6 | 61.5 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Response - Part A | Day 2 | 15.4 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Response - Part A | Day 3 | 15.4 percentage of participants |
Secondary
Percentage of Participants With HAM-D Response - Part B
HAM-D response was defined as having a 50% or greater reduction from baseline in HAM-D total score. The HAM-D total score comprised a sum of 17 individual item scores. Items scored in a range of 0 to 2 included: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items were scored in a range of 0 to 4: agitation, depressed mood, feelings of guilt, suicide, work and activities, retardation, anxiety (psychic and somatic), and hypochondriasis. The total score could range from 0 to 52. Higher scores indicated a greater degree of depression. A negative change from baseline indicated less depression. A positive change from baseline indicated more depression. The analysis was performed in participants included in Part B of the study. Data is reported for participants who had HAM-D response.
Time frame: Days 2, 8, 15, 21, 28, 35 and 42
Population: The efficacy set included all participants who were randomized and received at least 1 dose of the double-blind study drug and had a baseline and at least 1 post-baseline efficacy evaluation. Number analyzed: Number of participants in the efficacy set ith a non-missing value at the visit within each treatment group.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: SAGE-217 | Percentage of Participants With HAM-D Response - Part B | Day 15 | 40.5 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Response - Part B | Day 28 | 46.2 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Response - Part B | Day 8 | 47.6 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Response - Part B | Day 35 | 50.0 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Response - Part B | Day 21 | 42.1 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Response - Part B | Day 42 | 56.4 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With HAM-D Response - Part B | Day 2 | 4.5 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With HAM-D Response - Part B | Day 42 | 61.9 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With HAM-D Response - Part B | Day 2 | 15.6 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With HAM-D Response - Part B | Day 8 | 59.1 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With HAM-D Response - Part B | Day 15 | 78.6 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With HAM-D Response - Part B | Day 21 | 73.8 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With HAM-D Response - Part B | Day 28 | 61.9 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With HAM-D Response - Part B | Day 35 | 65.9 percentage of participants |
Comparison: Day 2p-value: 0.088495% CI: [0.8, 24.1]Generalized Estimating Equation
Comparison: Day 8p-value: 0.073295% CI: [0.9, 6.4]Generalized Estimating Equation
Comparison: Day 15p-value: 0.000295% CI: [2.9, 31.6]Generalized Estimating Equation
Comparison: Day 21p-value: 0.000695% CI: [2.3, 19.7]Generalized Estimating Equation
Comparison: Day 28p-value: 0.037995% CI: [1.1, 8.9]Generalized Estimating Equation
Comparison: Day 35p-value: 0.046895% CI: [1, 9]Generalized Estimating Equation
Comparison: Day 42p-value: 0.220895% CI: [0.7, 5.6]Generalized Estimating Equation
Secondary
Percentage of Participants With TEAEs, Graded by Severity - Part B
Severity was assessed according to the following scale: mild (awareness of sign or symptom, but easily tolerated); moderate (discomfort sufficient to cause interference with normal activities); severe (incapacitating, with inability to perform normal activities). The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 up to Day 21
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part A: SAGE-217 | Percentage of Participants With TEAEs, Graded by Severity - Part B | Moderate or Severe | 5 percentage of participants |
| Part A: SAGE-217 | Percentage of Participants With TEAEs, Graded by Severity - Part B | Severe | 0 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With TEAEs, Graded by Severity - Part B | Moderate or Severe | 6 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With TEAEs, Graded by Severity - Part B | Severe | 0 percentage of participants |
Secondary
Percentage of Participants With TEAEs - Part B
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. A TEAE was defined as an adverse event with onset after the start of study drug, or any worsening of a pre-existing medical condition/adverse event with onset after the start of study drug and until 7 days after the last dose. The analysis was performed in participants included in Part B of the study.
Time frame: Day 1 up to Day 21
Population: The safety set included all participants who received at least one dose of the study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Part A: SAGE-217 | Percentage of Participants With TEAEs - Part B | 45.5 percentage of participants |
| Part B: SAGE-217 | Percentage of Participants With TEAEs - Part B | 53.3 percentage of participants |