Postpartum Depression
Conditions
Keywords
Postpartum Care
Brief summary
The primary purpose of this study was to determine if treatment with SAGE-217 reduces depressive symptoms in participants with severe postpartum depression (PPD) compared to placebo as assessed by the change from baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D) total score at Day 15 and to evaluate the safety and tolerability of SAGE-217 compared to placebo as assessed by the incidence of adverse events, vital sign measurements, clinical laboratory evaluations, electrocardiogram (ECG) parameters, and the Columbia Suicide Severity Rating Scale (C-SSRS).
Detailed description
This study was previously posted by Sage Therapeutics. In November 2023, sponsorship of the trial was transferred to Biogen.
Interventions
DRUGSAGE-217 15/20 mg Oral Solution
SAGE-217, 15 mg oral solution, BID for Days 1 to 2 followed by 20 mg oral solution BID for Days 3 to 14. If not tolerated, 15 mg for the rest of study (Days 3 to 14).
DRUGPlacebo
SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days.
DRUGSAGE 217 30 mg Capsules
SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days.
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Participant either must have ceased lactating at screening or, if still lactating or actively breastfeeding at screening, must agree to temporarily cease giving breast milk to her infant(s) * Participant has had a Major Depressive Episode that began no earlier than the third trimester and no later than the first 4 weeks following delivery, as diagnosed by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 Axis I Disorders (SCID-I) * Participant was \<=six months postpartum. Key
Exclusion criteria
* Active psychosis * Attempted suicide associated with current episode of postpartum depression * Medical history of seizures * Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder. Note: suicidal ideation was not an exclusion. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 | Parts A and B: Baseline, Day 15 | The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are 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 HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Parts A and B: Percentage of Participants With HAM-D Response | Part B: Days 3, 8, 15, 21 and 45 | HAM-D Response was defined as having a 50 percent (%) or greater reduction from Baseline in HAM-D total score. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours \[morning\]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression. |
| Parts A and B: Percentage of Participants With HAM-D Remission | Part B: Days 3, 8, 15, 21 and 45 | HAM-D Remission was defined as a HAM-D total score of less than or equal to (\<=)7. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours \[morning\]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression. |
| Parts A and B: Change From Baseline in HAM-D Subscales Scores | Part B: Baseline, Days 3, 8, 15, 21 and 45 | HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. HAM-D subscales: Core subscale (symptoms-depressed mood, feelings of guilt, suicide, work and activities, and retardation ); Anxiety subscale (symptoms-anxiety \[psychic and somatic\], somatic symptoms \[gastrointestinal and general\], hypochondriasis, loss of weight); Bech-6 subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, and somatic symptoms general); Meier subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, agitation, and anxiety psychic). Each item was scored in a range of 0 to 2 or 0 to 4, higher scores=greater degree of depression. Subscale scores were calculated as the sum of the individual item scores comprising each subscale. Scores were transformed to a scale of 0 to 100, with higher scores indicated more severe depression. A negative change from Baseline indicates less depression. |
| Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Part B: Baseline, Days 3, 8, 15, 21 and 45 | The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Individual items on the scale were scored in a range of 0 to 2 or 0 to 4. Symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal 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 indicates less depression. |
| Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score | Part B: Baseline, Days 3, 8, 15, 21 and 45 | The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression. |
| Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Part B: Days 3, 8, 15, 21 and 45 | The Clinical Global Impression - Improvement (CGI-I) item of the CGI scale uses a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. 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. CGI response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved). The percentage of participants with overall improvement in post-treatment condition, rated by investigator as very much improved (CGI-I score of 1) or much improved (CGI-I score of 2) is reported. |
| Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Part B: Baseline, Days 3, 8, 15, 21 and 45 | 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). The individual items were scored in a range of 0 (not present) to 4 (very severe). The HAM-A total score was calculated as the sum of the 14 individual item scores and could range from 0 to 56 where a score of \<17=mild severity; 18-24= mild to moderate severity and 25-30=moderate to severe severity. A negative change from Baseline indicates less anxiety. |
| Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Part B: Baseline, Days 3, 8, 21 and 45 | The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are 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 HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression. |
| Parts A and B: Percentage of Participants With MADRS Remission | Part B: Days 3, 8, 15, 21 and 45 | MADRS Remission was defined as a MADRS total score of \<=10. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression. |
| Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Part A: Up to Day 75; Part B: Up to Day 45 | An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug. |
| Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Part B: From first dose of study drug up to 45 days | Vital signs included assessments of supine and standing systolic blood pressure (SBP), supine and standing diastolic blood pressure (DBP), and heart rate. |
| Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Part B: From first dose of study drug up to 45 days | Laboratory tests included tests of Hematology, Chemistry, and Urinalysis. |
| Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate | Part B: Baseline, Days 8, 15, and 21 | ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Heart rate was measured in terms of beats per minute. Change from Baseline in heart rate at specified time points were reported. |
| Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | Part B: Baseline, Days 8, 15, and 21 | ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Change from Baseline in PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval is reported. |
| Part B: Number of Participants With a Response of Yes to Any Suicidal Ideation or Suicidal Behaviors Item Using the Columbia Suicide Severity Rating Scale (C-SSRS) | Part B: Up to Day 45 | C-SSRS was used to assess the suicidality of participants during the study. The assessment included yes or no responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for severity of ideation (if present), from 1 to 5, with 5 being the most severe. Number of participants with a response of 'yes' to any suicidal ideation or suicidal behavior item as measured by C-SSRS is reported. |
| Parts A and B: Percentage of Participants With MADRS Response | Part B: Days 3, 8, 15, 21 and 45 | MADRS response was defined as having a 50% or greater reduction from Baseline in MADRS total score. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression. |
Countries
United States
Participant flow
Recruitment details
Participants took part in the study at 27 investigative centers in the United States of America from 04 January 2017 to 11 December 2018. Study was conducted in 2 parts. In Part A, only 1 participant was enrolled and thus no analysis was performed for Part A. All analysis sets were defined only for Part B. For Part A, only adverse events incidence were captured.
Pre-assignment details
A total of 276 participants were enrolled and consented of which 154 eligible participants were randomized and thus presented in participant flow. Rest of the 123 participants were not randomized and not part of any analyses. 152 randomized participants received study drug and 143 completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Part A: SAGE-217 15/20 mg Oral Solution Participants received SAGE-217, 15 mg, oral solution, BID for first 2 days followed by SAGE-217, 15 or 20 mg, oral solution, BID, starting on Day 3 for up to 14 days as tolerated. | 1 |
| Part B: Placebo Participants received SAGE-217 matching placebo, capsules, orally, once daily, for up to 14 days. | 74 |
| Part B: SAGE 217 30 mg Capsules Participants received SAGE-217, 30 mg, capsules, orally, once daily, for up to 14 days. | 76 |
| Total | 151 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Part B (Up to 45 Days) | Adverse Event | 0 | 0 | 1 |
| Part B (Up to 45 Days) | Lost to Follow-up | 0 | 3 | 0 |
| Part B (Up to 45 Days) | Non-compliance | 0 | 2 | 0 |
| Part B (Up to 45 Days) | Withdrawal by Subject | 0 | 2 | 3 |
Baseline characteristics
| Characteristic | Part B: Placebo | Total | Part B: SAGE 217 30 mg Capsules | Part A: SAGE-217 15/20 mg Oral Solution |
|---|---|---|---|---|
| 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score | 28.8 score on a scale | 28.6 score on a scale | 28.4 score on a scale | — |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 74 Participants | 151 Participants | 76 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 18 Participants | 34 Participants | 16 Participants | — |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants | 116 Participants | 60 Participants | — |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | — |
| HAM-D Individual Item Scores Agitation | 1.4 score on a scale | 1.4 score on a scale | 1.4 score on a scale | — |
| HAM-D Individual Item Scores Anxiety Psychic | 2.7 score on a scale | 2.8 score on a scale | 2.9 score on a scale | — |
| HAM-D Individual Item Scores Anxiety Somatic | 1.9 score on a scale | 1.9 score on a scale | 1.9 score on a scale | — |
| HAM-D Individual Item Scores Depressed Mood | 3.1 score on a scale | 3.1 score on a scale | 3.1 score on a scale | — |
| HAM-D Individual Item Scores Feelings of Guilt | 2.2 score on a scale | 2.35 score on a scale | 2.5 score on a scale | — |
| HAM-D Individual Item Scores General Somatic Symptoms | 1.8 score on a scale | 1.8 score on a scale | 1.8 score on a scale | — |
| HAM-D Individual Item Scores Genital Symptoms | 1.9 score on a scale | 1.9 score on a scale | 1.9 score on a scale | — |
| HAM-D Individual Item Scores Hypochondriasis | 1.3 score on a scale | 1.15 score on a scale | 1.0 score on a scale | — |
| HAM-D Individual Item Scores Insight | 0.1 score on a scale | 0.1 score on a scale | 0.1 score on a scale | — |
| HAM-D Individual Item Scores Insomnia Early - Early Night | 1.8 score on a scale | 1.8 score on a scale | 1.8 score on a scale | — |
| HAM-D Individual Item Scores Insomnia Early Hours - Morning | 1.5 score on a scale | 1.55 score on a scale | 1.6 score on a scale | — |
| HAM-D Individual Item Scores Insomnia Middle - Middle Night | 1.9 score on a scale | 1.8 score on a scale | 1.7 score on a scale | — |
| HAM-D Individual Item Scores Loss of Weight According to Patient | 0.9 score on a scale | 0.75 score on a scale | 0.6 score on a scale | — |
| HAM-D Individual Item Scores Retardation | 1.2 score on a scale | 1.2 score on a scale | 1.2 score on a scale | — |
| HAM-D Individual Item Scores Somatic Symptoms Gastrointestinal | 1.5 score on a scale | 1.4 score on a scale | 1.3 score on a scale | — |
| HAM-D Individual Item Scores Suicide | 0.4 score on a scale | 0.4 score on a scale | 0.4 score on a scale | — |
| HAM-D Individual Item Scores Work and Activities | 3.1 score on a scale | 3.05 score on a scale | 3.0 score on a scale | — |
| HAM-D Subscales Scores Anxiety | 56.3 score on a scale | 54.7 score on a scale | 53.1 score on a scale | — |
| HAM-D Subscales Scores Bech-6 | 64.5 score on a scale | 65.4 score on a scale | 66.3 score on a scale | — |
| HAM-D Subscales Scores Core | 50.1 score on a scale | 50.7 score on a scale | 51.3 score on a scale | — |
| HAM-D Subscales Scores Meier | 57.1 score on a scale | 58.1 score on a scale | 59.1 score on a scale | — |
| Hamilton Anxiety Rating Scale (HAM-A) Total Score | 27.2 score on a scale | 26.65 score on a scale | 26.1 score on a scale | — |
| Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score | 36.3 score on a scale | 35.6 score on a scale | 34.9 score on a scale | — |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 1 Participants | — |
| Race (NIH/OMB) Black or African American | 31 Participants | 62 Participants | 31 Participants | — |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants | — |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | — |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | — |
| Race (NIH/OMB) White | 40 Participants | 84 Participants | 44 Participants | — |
| Sex: Female, Male Female | 74 Participants | 151 Participants | 76 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 73 | 0 / 78 |
| other Total, other adverse events | 1 / 1 | 26 / 73 | 31 / 78 |
| serious Total, serious adverse events | 0 / 1 | 1 / 73 | 1 / 78 |
Outcome results
Primary
Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15
The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are 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 HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.
Time frame: Parts A and B: Baseline, Day 15
Population: Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Part B: Placebo | Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 | -13.6 score on a scale | Standard Error 1.07 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in the 17-Item Hamilton Rating Scale for Depression (HAM-D) Total Score at Day 15 | -17.8 score on a scale | Standard Error 1.04 |
p-value: 0.002895% CI: [-6.9, -1.5]Mixed Model for Repeated Measures
Secondary
Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval
ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Change from Baseline in PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval is reported.
Time frame: Part B: Baseline, Days 8, 15, and 21
Population: Safety Set (Part B) included all participants who were administered study drug in Part B and analyzed by treatment actually received.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QT Interval: Change From Baseline at Day 8 | -5.5 milliseconds | Standard Deviation 24.23 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | PR Interval: Change From Baseline at Day 8 | 3.4 milliseconds | Standard Deviation 26.97 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | PR Interval: Change From Baseline at Day 21 | 2.5 milliseconds | Standard Deviation 14.66 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | RR Interval: Baseline | 892.2 milliseconds | Standard Deviation 131.63 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | RR Interval: Change From Baseline at Day 8 | -9.9 milliseconds | Standard Deviation 137.12 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | RR Interval: Change From Baseline at Day 21 | -32.0 milliseconds | Standard Deviation 113.89 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QRS Duration: Change From Baseline at Day 8 | 0.0 milliseconds | Standard Deviation 8.19 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QRS Duration: Change From Baseline at Day 15 | -0.7 milliseconds | Standard Deviation 7.14 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QT Interval: Change From Baseline at Day 15 | -1.4 milliseconds | Standard Deviation 22.96 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QT Interval: Change From Baseline at Day 21 | -5.9 milliseconds | Standard Deviation 23.7 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QTcF Interval: Baseline | 411.3 milliseconds | Standard Deviation 20.92 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QTcF Interval: Change From Baseline at Day 8 | -4.1 milliseconds | Standard Deviation 15.8 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QTcF Interval: Change From Baseline at Day 15 | -1.2 milliseconds | Standard Deviation 14.75 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QTcF Interval: Change From Baseline at Day 21 | -1.1 milliseconds | Standard Deviation 19.39 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | PR Interval: Baseline | 151.4 milliseconds | Standard Deviation 20.38 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | PR Interval: Change From Baseline at Day 15 | 1.1 milliseconds | Standard Deviation 11.81 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | RR Interval: Change From Baseline at Day 15 | -1.9 milliseconds | Standard Deviation 107.37 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QRS Duration: Baseline | 87.3 milliseconds | Standard Deviation 9.5 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QRS Duration: Change From Baseline at Day 21 | 0.1 milliseconds | Standard Deviation 7.58 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QT Interval: Baseline | 395.1 milliseconds | Standard Deviation 28.85 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | PR Interval: Change From Baseline at Day 15 | 0.8 milliseconds | Standard Deviation 11.02 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QTcF Interval: Baseline | 412.2 milliseconds | Standard Deviation 18.83 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | PR Interval: Change From Baseline at Day 8 | 0.6 milliseconds | Standard Deviation 11.95 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QRS Duration: Change From Baseline at Day 21 | 0.0 milliseconds | Standard Deviation 6.84 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | PR Interval: Change From Baseline at Day 21 | 2.5 milliseconds | Standard Deviation 11.82 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QTcF Interval: Change From Baseline at Day 8 | -1.7 milliseconds | Standard Deviation 15.57 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | RR Interval: Baseline | 871.6 milliseconds | Standard Deviation 124.16 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | RR Interval: Change From Baseline at Day 21 | 13.9 milliseconds | Standard Deviation 141.69 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | RR Interval: Change From Baseline at Day 8 | -16.9 milliseconds | Standard Deviation 149.42 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | RR Interval: Change From Baseline at Day 15 | -8.4 milliseconds | Standard Deviation 147.36 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QTcF Interval: Change From Baseline at Day 15 | -1.5 milliseconds | Standard Deviation 14.94 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | PR Interval: Baseline | 151.7 milliseconds | Standard Deviation 17.12 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QRS Duration: Change From Baseline at Day 8 | -0.3 milliseconds | Standard Deviation 6.98 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QTcF Interval: Change From Baseline at Day 21 | -1.8 milliseconds | Standard Deviation 20.77 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QRS Duration: Change From Baseline at Day 15 | -0.3 milliseconds | Standard Deviation 6.69 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QT Interval: Change From Baseline at Day 8 | -4.3 milliseconds | Standard Deviation 29.89 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QRS Duration: Baseline | 90.2 milliseconds | Standard Deviation 9.81 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QT Interval: Change From Baseline at Day 15 | -2.7 milliseconds | Standard Deviation 28.53 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QT Interval: Baseline | 393.0 milliseconds | Standard Deviation 28.66 |
| Part B: Placebo | Part B: Change From Baseline in ECG Parameters-PR Interval, RR Interval, QRS Duration, QT Interval, QTcF Interval | QT Interval: Change From Baseline at Day 21 | 0.1 milliseconds | Standard Deviation 30.6 |
Secondary
Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate
ECG parameters included assessment of the standard 12-lead ECG intervals: QT, QTcF, PR, RR, QRS, and heart rate. Heart rate was measured in terms of beats per minute. Change from Baseline in heart rate at specified time points were reported.
Time frame: Part B: Baseline, Days 8, 15, and 21
Population: Safety Set (Part B) included all participants who were administered study drug in Part B and analyzed by treatment actually received. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate | Baseline | 68.2 beats per minute | Standard Deviation 9.55 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate | Change From Baseline at Day 8 | 0.8 beats per minute | Standard Deviation 9.91 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate | Change From Baseline at Day 15 | -0.1 beats per minute | Standard Deviation 8.16 |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate | Change From Baseline at Day 21 | 2.5 beats per minute | Standard Deviation 8.93 |
| Part B: Placebo | Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate | Change From Baseline at Day 21 | -0.6 beats per minute | Standard Deviation 11.33 |
| Part B: Placebo | Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate | Baseline | 69.9 beats per minute | Standard Deviation 10.85 |
| Part B: Placebo | Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate | Change From Baseline at Day 15 | 0.9 beats per minute | Standard Deviation 12.69 |
| Part B: Placebo | Part B: Change From Baseline in Electrocardiogram (ECG) Parameter Heart Rate | Change From Baseline at Day 8 | 1.5 beats per minute | Standard Deviation 12.62 |
Secondary
Part B: Number of Participants With a Response of Yes to Any Suicidal Ideation or Suicidal Behaviors Item Using the Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS was used to assess the suicidality of participants during the study. The assessment included yes or no responses for 5 questions, each related to suicidal ideation (wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with any methods, active suicidal ideation with some intent, active suicidal ideation with specific plan) and suicidal behavior (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, suicide). Numeric ratings were provided for severity of ideation (if present), from 1 to 5, with 5 being the most severe. Number of participants with a response of 'yes' to any suicidal ideation or suicidal behavior item as measured by C-SSRS is reported.
Time frame: Part B: Up to Day 45
Population: Safety Set (Part B) included all participants who were administered study drug in Part B and analyzed by treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With a Response of Yes to Any Suicidal Ideation or Suicidal Behaviors Item Using the Columbia Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation | 13 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With a Response of Yes to Any Suicidal Ideation or Suicidal Behaviors Item Using the Columbia Suicide Severity Rating Scale (C-SSRS) | Suicidal Behavior | 0 Participants |
| Part B: Placebo | Part B: Number of Participants With a Response of Yes to Any Suicidal Ideation or Suicidal Behaviors Item Using the Columbia Suicide Severity Rating Scale (C-SSRS) | Suicidal Ideation | 6 Participants |
| Part B: Placebo | Part B: Number of Participants With a Response of Yes to Any Suicidal Ideation or Suicidal Behaviors Item Using the Columbia Suicide Severity Rating Scale (C-SSRS) | Suicidal Behavior | 0 Participants |
Secondary
Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations
Laboratory tests included tests of Hematology, Chemistry, and Urinalysis.
Time frame: Part B: From first dose of study drug up to 45 days
Population: Safety Set (Part B) included all participants who were administered study drug in Part B and analyzed by treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Sodium >145 mmol/L | 3 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Hematology: Hemoglobin <110 g/L | 12 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Hematology: Leukocytes <2.5 10^9/L | 2 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Hematology: Neutrophils <1.5 10^9/L | 15 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Calcium <2.0 millimoles (mmol)/L | 0 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Chloride <90 mmol/L | 1 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Glucose <2.8 mmol/L | 0 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Glucose >13.9 mmol/L | 0 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Potassium <3.5 mmol/L | 0 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Hematology: Hematocrit <0.359 | 11 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Hematology: Hematocrit >0.446 | 10 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Alanine Aminotransferase >3xUpper Limit of Normal Value (ULN) | 1 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Phosphate >5 milligrams/deciliter (mg/dL) | 2 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Potassium >5.2 mmol/L | 6 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Hematology: Eosinophils >1.5 10^9/Liter(L) | 0 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Hematology: Hematocrit >0.446 | 12 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Hematology: Eosinophils >1.5 10^9/Liter(L) | 1 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Phosphate >5 milligrams/deciliter (mg/dL) | 1 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Hematology: Hemoglobin <110 g/L | 6 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Potassium <3.5 mmol/L | 1 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Hematology: Leukocytes <2.5 10^9/L | 2 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Sodium >145 mmol/L | 5 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Hematology: Neutrophils <1.5 10^9/L | 11 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Alanine Aminotransferase >3xUpper Limit of Normal Value (ULN) | 0 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Glucose >13.9 mmol/L | 1 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Calcium <2.0 millimoles (mmol)/L | 1 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Hematology: Hematocrit <0.359 | 8 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Chloride <90 mmol/L | 2 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Potassium >5.2 mmol/L | 5 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Laboratory Evaluations | Serum Chemistry: Glucose <2.8 mmol/L | 1 Participants |
Secondary
Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements
Vital signs included assessments of supine and standing systolic blood pressure (SBP), supine and standing diastolic blood pressure (DBP), and heart rate.
Time frame: Part B: From first dose of study drug up to 45 days
Population: Safety Set (Part B) included all participants who were administered study drug in Part B of the study and analyzed by treatment actually received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Standing DBP: <50 mmHg | 1 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Supine SBP: Decrease From Baseline of >=30 | 2 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Supine SBP: Increase From Baseline of >=30 | 1 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Standing SBP: Increase From Baseline of >=30 | 1 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Supine DBP: Increase From Baseline of >=20 | 1 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Standing DBP: >110 mmHg | 0 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Standing DBP: Decrease From Baseline of >=20 | 3 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Standing DBP: Increase From Baseline of >=20 | 3 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Standing SBP: <90 mmHg | 5 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Standing SBP: Decrease From Baseline of >=30 | 4 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Supine DBP: <50 mmHg | 1 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Supine DBP: Decrease From Baseline of >=20 | 5 Participants |
| Part A: SAGE-217 15/20 mg Oral Solution | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Supine SBP: <90 millimeter of mercury (mmHg) | 0 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Supine DBP: <50 mmHg | 1 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Standing DBP: Decrease From Baseline of >=20 | 7 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Supine SBP: Decrease From Baseline of >=30 | 1 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Standing SBP: <90 mmHg | 4 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Standing SBP: Decrease From Baseline of >=30 | 1 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Standing DBP: Increase From Baseline of >=20 | 4 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Standing SBP: Increase From Baseline of >=30 | 2 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Supine DBP: Decrease From Baseline of >=20 | 3 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Supine SBP: <90 millimeter of mercury (mmHg) | 3 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Supine DBP: Increase From Baseline of >=20 | 5 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Standing DBP: <50 mmHg | 1 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Supine SBP: Increase From Baseline of >=30 | 0 Participants |
| Part B: Placebo | Part B: Number of Participants With Potentially Clinically Significant Vital Sign Measurements | Standing DBP: >110 mmHg | 1 Participants |
Secondary
Parts A and B: Change From Baseline in HAM-D Individual Item Scores
The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Individual items on the scale were scored in a range of 0 to 2 or 0 to 4. Symptoms scored in a range of 0 to 2: insomnia (early, middle, late), somatic symptoms (gastrointestinal 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 indicates less depression.
Time frame: Part B: Baseline, Days 3, 8, 15, 21 and 45
Population: Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt: Change From Baseline at Day 21 | -1.2 score on a scale | Standard Error 0.13 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Agitation: Change From Baseline at Day 8 | -0.6 score on a scale | Standard Error 0.09 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early - Early Night: Change From Baseline at Day 45 | -1.0 score on a scale | Standard Error 0.12 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Agitation: Change From Baseline at Day 15 | -0.6 score on a scale | Standard Error 0.09 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Depressed Mood: Change From Baseline at Day 21 | -1.5 score on a scale | Standard Error 0.14 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Agitation: Change From Baseline at Day 21 | -0.8 score on a scale | Standard Error 0.09 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Middle - Middle Night: Change From Baseline at Day 3 | -1.0 score on a scale | Standard Error 0.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Agitation: Change From Baseline at Day 45 | -0.8 score on a scale | Standard Error 0.09 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt: Change From Baseline at Day 45 | -1.5 score on a scale | Standard Error 0.12 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic: Change From Baseline at Day 3 | -0.7 score on a scale | Standard Error 0.12 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Middle - Middle Night: Change From Baseline at Day 8 | -1.0 score on a scale | Standard Error 0.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic: Change From Baseline at Day 21 | -0.9 score on a scale | Standard Error 0.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic: Change From Baseline at Day 15 | -1.2 score on a scale | Standard Error 0.13 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Middle - Middle Night: Change From Baseline at Day 15 | -0.9 score on a scale | Standard Error 0.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic: Change From Baseline at Day 21 | -1.3 score on a scale | Standard Error 0.14 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Suicide: Change From Baseline at Day 3 | -0.2 score on a scale | Standard Error 0.05 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic: Change From Baseline at Day 45 | -1.3 score on a scale | Standard Error 0.14 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Middle - Middle Night: Change From Baseline at Day 21 | -0.8 score on a scale | Standard Error 0.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic: Change From Baseline at Day 3 | -0.6 score on a scale | Standard Error 0.1 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Depressed Mood: Change From Baseline at Day 45 | -1.7 score on a scale | Standard Error 0.15 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic: Change From Baseline at Day 8 | -0.7 score on a scale | Standard Error 0.1 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Middle - Middle Night: Change From Baseline at Day 45 | -0.9 score on a scale | Standard Error 0.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic: Change From Baseline at Day 15 | -0.8 score on a scale | Standard Error 0.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Suicide: Change From Baseline at Day 8 | -0.2 score on a scale | Standard Error 0.04 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early Hours - Morning: Change From Baseline at Day 3 | -0.8 score on a scale | Standard Error 0.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms Gastrointestinal: Change From Baseline at Day 3 | -0.3 score on a scale | Standard Error 0.09 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Depressed Mood: Change From Baseline at Day 8 | -1.3 score on a scale | Standard Error 0.14 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms Gastrointestinal: Change From Baseline at Day 8 | -0.6 score on a scale | Standard Error 0.1 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early Hours - Morning: Change From Baseline at Day 15 | -1.0 score on a scale | Standard Error 0.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms Gastrointestinal: Change From Baseline at Day 15 | -0.7 score on a scale | Standard Error 0.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Suicide: Change From Baseline at Day 15 | -0.3 score on a scale | Standard Error 0.04 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early Hours - Morning: Change From Baseline at Day 21 | -0.9 score on a scale | Standard Error 0.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms Gastrointestinal: Change From Baseline at Day 21 | -0.8 score on a scale | Standard Error 0.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt: Change From Baseline at Day 3 | -0.9 score on a scale | Standard Error 0.12 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms Gastrointestinal: Change From Baseline at Day 45 | -0.8 score on a scale | Standard Error 0.1 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early Hours - Morning: Change From Baseline at Day 45 | -0.9 score on a scale | Standard Error 0.1 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | General Somatic Symptoms: Change From Baseline at Day 3 | -0.6 score on a scale | Standard Error 0.08 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Suicide: Change From Baseline at Day 21 | -0.2 score on a scale | Standard Error 0.05 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | General Somatic Symptoms: Change From Baseline at Day 8 | -0.8 score on a scale | Standard Error 0.09 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Work and Activities: Change From Baseline at Day 3 | -0.8 score on a scale | Standard Error 0.12 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | General Somatic Symptoms: Change From Baseline at Day 15 | -0.6 score on a scale | Standard Error 0.08 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | General Somatic Symptoms: Change From Baseline at Day 21 | -0.7 score on a scale | Standard Error 0.1 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic: Change From Baseline at Day 45 | -0.8 score on a scale | Standard Error 0.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | General Somatic Symptoms: Change From Baseline at Day 45 | -0.8 score on a scale | Standard Error 0.09 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Work and Activities: Change From Baseline at Day 8 | -1.3 score on a scale | Standard Error 0.14 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms: Change From Baseline at Day 3 | -0.3 score on a scale | Standard Error 0.08 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Suicide: Change From Baseline at Day 45 | -0.2 score on a scale | Standard Error 0.05 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms: Change From Baseline at Day 8 | -0.6 score on a scale | Standard Error 0.1 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Work and Activities: Change From Baseline at Day 15 | -1.4 score on a scale | Standard Error 0.14 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms: Change From Baseline at Day 15 | -0.7 score on a scale | Standard Error 0.1 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt: Change From Baseline at Day 8 | -1.1 score on a scale | Standard Error 0.13 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms: Change From Baseline at Day 21 | -0.7 score on a scale | Standard Error 0.1 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Work and Activities: Change From Baseline at Day 21 | -1.7 score on a scale | Standard Error 0.16 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms: Change From Baseline at Day 45 | -0.8 score on a scale | Standard Error 0.1 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early - Early Night: Change From Baseline at Day 3 | -0.9 score on a scale | Standard Error 0.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis: Change From Baseline at Day 3 | -0.5 score on a scale | Standard Error 0.09 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Work and Activities: Change From Baseline at Day 45 | -1.7 score on a scale | Standard Error 0.16 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis: Change From Baseline at Day 8 | -0.6 score on a scale | Standard Error 0.08 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Depressed Mood: Change From Baseline at Day 15 | -1.5 score on a scale | Standard Error 0.15 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis: Change From Baseline at Day 15 | -0.5 score on a scale | Standard Error 0.1 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Retardation: Change From Baseline at Day 3 | -0.5 score on a scale | Standard Error 0.07 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis: Change From Baseline at Day 21 | -0.6 score on a scale | Standard Error 0.08 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early - Early Night: Change From Baseline at Day 8 | -0.9 score on a scale | Standard Error 0.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis: Change From Baseline at Day 45 | -0.7 score on a scale | Standard Error 0.09 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Retardation: Change From Baseline at Day 8 | -0.7 score on a scale | Standard Error 0.08 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Loss of Weight According to Patient: Change From Baseline at Day 3 | -0.3 score on a scale | Standard Error 0.08 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt: Change From Baseline at Day 15 | -1.3 score on a scale | Standard Error 0.13 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Loss of Weight According to Patient: Change From Baseline at Day 8 | -0.4 score on a scale | Standard Error 0.07 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Retardation: Change From Baseline at Day 15 | -0.8 score on a scale | Standard Error 0.07 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Loss of Weight According to Patient: Change From Baseline at Day 15 | -0.5 score on a scale | Standard Error 0.07 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early - Early Night: Change From Baseline at Day 15 | -0.9 score on a scale | Standard Error 0.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Loss of Weight According to Patient: Change From Baseline at Day 21 | -0.6 score on a scale | Standard Error 0.06 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Retardation: Change From Baseline at Day 21 | -0.8 score on a scale | Standard Error 0.08 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Loss of Weight According to Patient: Change From Baseline at Day 45 | -0.5 score on a scale | Standard Error 0.08 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Depressed Mood: Change From Baseline at Day 3 | -0.8 score on a scale | Standard Error 0.13 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insight: Change From Baseline at Day 3 | 0.0 score on a scale | Standard Error 0.02 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Retardation: Change From Baseline at Day 45 | -0.9 score on a scale | Standard Error 0.07 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insight: Change From Baseline at Day 8 | 0.0 score on a scale | Standard Error 0.02 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic: Change From Baseline at Day 8 | -1.1 score on a scale | Standard Error 0.14 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insight: Change From Baseline at Day 15 | 0.0 score on a scale | Standard Error 0.02 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early - Early Night: Change From Baseline at Day 21 | -0.9 score on a scale | Standard Error 0.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insight: Change From Baseline at Day 21 | 0.0 score on a scale | Standard Error 0.02 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Agitation: Change From Baseline at Day 3 | -0.4 score on a scale | Standard Error 0.09 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insight: Change From Baseline at Day 45 | 0.0 score on a scale | Standard Error 0.04 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early Hours - Morning: Change From Baseline at Day 8 | -0.9 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insight: Change From Baseline at Day 45 | -0.1 score on a scale | Standard Error 0.02 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early Hours - Morning: Change From Baseline at Day 8 | -1.2 score on a scale | Standard Error 0.09 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic: Change From Baseline at Day 21 | -1.0 score on a scale | Standard Error 0.11 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Depressed Mood: Change From Baseline at Day 3 | -1.1 score on a scale | Standard Error 0.13 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Depressed Mood: Change From Baseline at Day 8 | -1.7 score on a scale | Standard Error 0.13 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Depressed Mood: Change From Baseline at Day 15 | -1.8 score on a scale | Standard Error 0.13 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Depressed Mood: Change From Baseline at Day 21 | -2.1 score on a scale | Standard Error 0.13 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Depressed Mood: Change From Baseline at Day 45 | -2.1 score on a scale | Standard Error 0.12 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt: Change From Baseline at Day 3 | -1.0 score on a scale | Standard Error 0.13 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt: Change From Baseline at Day 8 | -1.4 score on a scale | Standard Error 0.12 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt: Change From Baseline at Day 15 | -1.5 score on a scale | Standard Error 0.11 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt: Change From Baseline at Day 21 | -1.6 score on a scale | Standard Error 0.12 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Feelings of Guilt: Change From Baseline at Day 45 | -1.8 score on a scale | Standard Error 0.11 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Suicide: Change From Baseline at Day 3 | -0.3 score on a scale | Standard Error 0.04 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Suicide: Change From Baseline at Day 8 | -0.4 score on a scale | Standard Error 0.03 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Suicide: Change From Baseline at Day 15 | -0.3 score on a scale | Standard Error 0.04 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Suicide: Change From Baseline at Day 21 | -0.3 score on a scale | Standard Error 0.05 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Suicide: Change From Baseline at Day 45 | -0.4 score on a scale | Standard Error 0.03 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early - Early Night: Change From Baseline at Day 3 | -1.2 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early - Early Night: Change From Baseline at Day 8 | -1.3 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early - Early Night: Change From Baseline at Day 15 | -1.3 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early - Early Night: Change From Baseline at Day 21 | -1.1 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early - Early Night: Change From Baseline at Day 45 | -1.1 score on a scale | Standard Error 0.11 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Middle - Middle Night: Change From Baseline at Day 3 | -1.3 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Middle - Middle Night: Change From Baseline at Day 8 | -1.3 score on a scale | Standard Error 0.09 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Middle - Middle Night: Change From Baseline at Day 15 | -1.3 score on a scale | Standard Error 0.09 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Middle - Middle Night: Change From Baseline at Day 21 | -1.2 score on a scale | Standard Error 0.09 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Middle - Middle Night: Change From Baseline at Day 45 | -1.3 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early Hours - Morning: Change From Baseline at Day 3 | -1.1 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early Hours - Morning: Change From Baseline at Day 15 | -1.2 score on a scale | Standard Error 0.09 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early Hours - Morning: Change From Baseline at Day 21 | -1.0 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insomnia Early Hours - Morning: Change From Baseline at Day 45 | -1.3 score on a scale | Standard Error 0.08 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Work and Activities: Change From Baseline at Day 3 | -0.9 score on a scale | Standard Error 0.13 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Work and Activities: Change From Baseline at Day 8 | -1.4 score on a scale | Standard Error 0.14 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Work and Activities: Change From Baseline at Day 15 | -1.8 score on a scale | Standard Error 0.13 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Work and Activities: Change From Baseline at Day 21 | -1.9 score on a scale | Standard Error 0.14 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Work and Activities: Change From Baseline at Day 45 | -2.1 score on a scale | Standard Error 0.14 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Retardation: Change From Baseline at Day 3 | -0.4 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Retardation: Change From Baseline at Day 8 | -0.8 score on a scale | Standard Error 0.07 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Retardation: Change From Baseline at Day 15 | -0.8 score on a scale | Standard Error 0.07 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Retardation: Change From Baseline at Day 21 | -0.8 score on a scale | Standard Error 0.07 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Retardation: Change From Baseline at Day 45 | -1.0 score on a scale | Standard Error 0.07 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Agitation: Change From Baseline at Day 3 | -0.7 score on a scale | Standard Error 0.09 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Agitation: Change From Baseline at Day 8 | -0.9 score on a scale | Standard Error 0.08 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Agitation: Change From Baseline at Day 15 | -0.9 score on a scale | Standard Error 0.09 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Agitation: Change From Baseline at Day 21 | -0.9 score on a scale | Standard Error 0.08 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Agitation: Change From Baseline at Day 45 | -1.1 score on a scale | Standard Error 0.07 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic: Change From Baseline at Day 3 | -1.1 score on a scale | Standard Error 0.13 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic: Change From Baseline at Day 8 | -1.5 score on a scale | Standard Error 0.13 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic: Change From Baseline at Day 15 | -1.6 score on a scale | Standard Error 0.13 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic: Change From Baseline at Day 21 | -1.6 score on a scale | Standard Error 0.12 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Psychic: Change From Baseline at Day 45 | -1.7 score on a scale | Standard Error 0.12 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic: Change From Baseline at Day 3 | -0.7 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic: Change From Baseline at Day 8 | -0.9 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic: Change From Baseline at Day 15 | -0.9 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Anxiety Somatic: Change From Baseline at Day 45 | -1.0 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms Gastrointestinal: Change From Baseline at Day 3 | -0.6 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms Gastrointestinal: Change From Baseline at Day 8 | -0.8 score on a scale | Standard Error 0.09 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | General Somatic Symptoms: Change From Baseline at Day 15 | -1.1 score on a scale | Standard Error 0.09 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms Gastrointestinal: Change From Baseline at Day 15 | -1.0 score on a scale | Standard Error 0.08 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms Gastrointestinal: Change From Baseline at Day 21 | -0.9 score on a scale | Standard Error 0.09 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Somatic Symptoms Gastrointestinal: Change From Baseline at Day 45 | -1.0 score on a scale | Standard Error 0.09 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | General Somatic Symptoms: Change From Baseline at Day 3 | -0.7 score on a scale | Standard Error 0.09 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | General Somatic Symptoms: Change From Baseline at Day 8 | -0.9 score on a scale | Standard Error 0.09 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | General Somatic Symptoms: Change From Baseline at Day 21 | -1.0 score on a scale | Standard Error 0.08 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | General Somatic Symptoms: Change From Baseline at Day 45 | -1.0 score on a scale | Standard Error 0.09 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms: Change From Baseline at Day 3 | -0.4 score on a scale | Standard Error 0.09 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms: Change From Baseline at Day 8 | -0.6 score on a scale | Standard Error 0.09 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms: Change From Baseline at Day 15 | -0.9 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms: Change From Baseline at Day 21 | -0.8 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Genital Symptoms: Change From Baseline at Day 45 | -1.0 score on a scale | Standard Error 0.1 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis: Change From Baseline at Day 3 | -0.7 score on a scale | Standard Error 0.08 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis: Change From Baseline at Day 8 | -0.8 score on a scale | Standard Error 0.07 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis: Change From Baseline at Day 15 | -1.0 score on a scale | Standard Error 0.06 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis: Change From Baseline at Day 21 | -0.9 score on a scale | Standard Error 0.06 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Hypochondriasis: Change From Baseline at Day 45 | -0.9 score on a scale | Standard Error 0.07 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Loss of Weight According to Patient: Change From Baseline at Day 3 | -0.5 score on a scale | Standard Error 0.07 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Loss of Weight According to Patient: Change From Baseline at Day 8 | -0.5 score on a scale | Standard Error 0.07 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Loss of Weight According to Patient: Change From Baseline at Day 15 | -0.5 score on a scale | Standard Error 0.06 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Loss of Weight According to Patient: Change From Baseline at Day 21 | -0.6 score on a scale | Standard Error 0.05 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Loss of Weight According to Patient: Change From Baseline at Day 45 | -0.6 score on a scale | Standard Error 0.05 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insight: Change From Baseline at Day 3 | -0.1 score on a scale | Standard Error 0.02 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insight: Change From Baseline at Day 8 | -0.1 score on a scale | Standard Error 0.02 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insight: Change From Baseline at Day 15 | -0.1 score on a scale | Standard Error 0.02 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Individual Item Scores | Insight: Change From Baseline at Day 21 | -0.1 score on a scale | Standard Error 0.02 |
Comparison: Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 3p-value: 0.156995% CI: [-0.5, 0.1]Mixed Model for Repeated Measures
Comparison: Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 8p-value: 0.037695% CI: [-0.7, 0]Mixed Model for Repeated Measures
Comparison: Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 15p-value: 0.103595% CI: [-0.6, 0.1]Mixed Model for Repeated Measures
Comparison: Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 21p-value: 0.003795% CI: [-0.9, -0.2]Mixed Model for Repeated Measures
Comparison: Depressed Mood: Change From Baseline in HAM-D Individual Item Score at Day 45p-value: 0.006195% CI: [-0.8, -0.1]Mixed Model for Repeated Measures
Comparison: Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 3p-value: 0.787895% CI: [-0.4, 0.3]Mixed Model for Repeated Measures
Comparison: Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 8p-value: 0.049895% CI: [-0.6, 0]Mixed Model for Repeated Measures
Comparison: Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 15p-value: 0.171995% CI: [-0.5, 0.1]Mixed Model for Repeated Measures
Comparison: Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 21p-value: 0.016195% CI: [-0.7, -0.1]Mixed Model for Repeated Measures
Comparison: Feelings of Guilt: Change From Baseline in HAM-D Individual Item Score at Day 45p-value: 0.019195% CI: [-0.6, -0.1]Mixed Model for Repeated Measures
Comparison: Suicide: Change From Baseline in HAM-D Individual Item Score at Day 3p-value: 0.253795% CI: [-0.2, 0.1]Mixed Model for Repeated Measures
Comparison: Suicide: Change From Baseline in HAM-D Individual Item Score at Day 8p-value: 0.001895% CI: [-0.2, -0.1]Mixed Model for Repeated Measures
Comparison: Suicide: Change From Baseline in HAM-D Individual Item Score at Day 15p-value: 0.287895% CI: [-0.2, 0]Mixed Model for Repeated Measures
Comparison: Suicide: Change From Baseline in HAM-D Individual Item Score at Day 21p-value: 0.259495% CI: [-0.2, 0.1]Mixed Model for Repeated Measures
Comparison: Suicide: Change From Baseline in HAM-D Individual Item Score at Day 45p-value: 0.008695% CI: [-0.3, 0]Mixed Model for Repeated Measures
Comparison: Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 3p-value: 0.042495% CI: [-0.6, 0]Mixed Model for Repeated Measures
Comparison: Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 8p-value: 0.020795% CI: [-0.6, 0]Mixed Model for Repeated Measures
Comparison: Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 15p-value: 0.00195% CI: [-0.7, -0.2]Mixed Model for Repeated Measures
Comparison: Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 21p-value: 0.087195% CI: [-0.5, 0]Mixed Model for Repeated Measures
Comparison: Insomnia Early - Early Night: Change From Baseline in HAM-D Individual Item Score at Day 45p-value: 0.56895% CI: [-0.4, 0.2]Mixed Model for Repeated Measures
Comparison: Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 3p-value: 0.014395% CI: [-0.6, -0.1]Mixed Model for Repeated Measures
Comparison: Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 8p-value: 0.006395% CI: [-0.6, -0.1]Mixed Model for Repeated Measures
Comparison: Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 15p-value: 0.004295% CI: [-0.6, -0.1]Mixed Model for Repeated Measures
Comparison: Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 21p-value: 0.013795% CI: [-0.6, -0.1]Mixed Model for Repeated Measures
Comparison: Insomnia Middle - Middle Night: Change From Baseline in HAM-D Individual Item Score at Day 45p-value: 0.009995% CI: [-0.6, -0.1]Mixed Model for Repeated Measures
Comparison: Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 3p-value: 0.050795% CI: [-0.5, 0]Mixed Model for Repeated Measures
Comparison: Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 8p-value: 0.020595% CI: [-0.5, 0]Mixed Model for Repeated Measures
Comparison: Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 15p-value: 0.140995% CI: [-0.5, 0.1]Mixed Model for Repeated Measures
Comparison: Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 21p-value: 0.202195% CI: [-0.5, 0.1]Mixed Model for Repeated Measures
Comparison: Insomnia Early Hours - Morning: Change From Baseline in HAM-D Individual Item Score at Day 45p-value: 0.011795% CI: [-0.6, -0.1]Mixed Model for Repeated Measures
Comparison: Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 3p-value: 0.551195% CI: [-0.4, 0.2]Mixed Model for Repeated Measures
Comparison: Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 8p-value: 0.494995% CI: [-0.5, 0.2]Mixed Model for Repeated Measures
Comparison: Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 15p-value: 0.020395% CI: [-0.7, -0.1]Mixed Model for Repeated Measures
Comparison: Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 21p-value: 0.207695% CI: [-0.6, 0.1]Mixed Model for Repeated Measures
Comparison: Work and Activities: Change From Baseline in HAM-D Individual Item Score at Day 45p-value: 0.036295% CI: [-0.8, 0]Mixed Model for Repeated Measures
Comparison: Retardation: Change From Baseline in HAM-D Individual Item Score at Day 3p-value: 0.358995% CI: [-0.1, 0.3]Mixed Model for Repeated Measures
Comparison: Retardation: Change From Baseline in HAM-D Individual Item Score at Day 8p-value: 0.699195% CI: [-0.2, 0.2]Mixed Model for Repeated Measures
Comparison: Retardation: Change From Baseline in HAM-D Individual Item Score at Day 15p-value: 0.965595% CI: [-0.2, 0.2]Mixed Model for Repeated Measures
Comparison: Retardation: Change From Baseline in HAM-D Individual Item Score at Day 21p-value: 0.869995% CI: [-0.2, 0.2]Mixed Model for Repeated Measures
Comparison: Retardation: Change From Baseline in HAM-D Individual Item Score at Day 45p-value: 0.371595% CI: [-0.3, 0.1]Mixed Model for Repeated Measures
Comparison: Agitation: Change From Baseline in HAM-D Individual Item Score at Day 3p-value: 0.06795% CI: [-0.4, 0]Mixed Model for Repeated Measures
Comparison: Agitation: Change From Baseline in HAM-D Individual Item Score at Day 8p-value: 0.010495% CI: [-0.5, -0.1]Mixed Model for Repeated Measures
Comparison: Agitation: Change From Baseline in HAM-D Individual Item Score at Day 15p-value: 0.012295% CI: [-0.5, -0.1]Mixed Model for Repeated Measures
Comparison: Agitation: Change From Baseline in HAM-D Individual Item Score at Day 21p-value: 0.315795% CI: [-0.3, 0.1]Mixed Model for Repeated Measures
Comparison: Agitation: Change From Baseline in HAM-D Individual Item Score at Day 45p-value: 0.007795% CI: [-0.5, -0.1]Mixed Model for Repeated Measures
Comparison: Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 3p-value: 0.007895% CI: [-0.8, -0.1]Mixed Model for Repeated Measures
Comparison: Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 8p-value: 0.037295% CI: [-0.7, 0]Mixed Model for Repeated Measures
Comparison: Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 15p-value: 0.024495% CI: [-0.7, -0.1]Mixed Model for Repeated Measures
Comparison: Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 21p-value: 0.099395% CI: [-0.6, 0.1]Mixed Model for Repeated Measures
Comparison: Anxiety Psychic: Change From Baseline in HAM-D Individual Item Score at Day 45p-value: 0.018595% CI: [-0.7, -0.1]Mixed Model for Repeated Measures
Comparison: Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 3p-value: 0.247195% CI: [-0.4, 0.1]Mixed Model for Repeated Measures
Comparison: Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 8p-value: 0.107695% CI: [-0.5, 0]Mixed Model for Repeated Measures
Comparison: Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 15p-value: 0.278295% CI: [-0.4, 0.1]Mixed Model for Repeated Measures
Comparison: Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 21p-value: 0.464695% CI: [-0.4, 0.2]Mixed Model for Repeated Measures
Comparison: Anxiety Somatic: Change From Baseline in HAM-D Individual Item Score at Day 45p-value: 0.1695% CI: [-0.5, 0.1]Mixed Model for Repeated Measures
Comparison: Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 3p-value: 0.047495% CI: [-0.5, 0]Mixed Model for Repeated Measures
Comparison: Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 8p-value: 0.044695% CI: [-0.5, 0]Mixed Model for Repeated Measures
Comparison: Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 15p-value: 0.009395% CI: [-0.6, -0.1]Mixed Model for Repeated Measures
Comparison: Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 21p-value: 0.299895% CI: [-0.4, 0.1]Mixed Model for Repeated Measures
Comparison: Somatic Symptoms Gastrointestinal: Change From Baseline in HAM-D Individual Item Score at Day 45p-value: 0.054595% CI: [-0.5, 0]Mixed Model for Repeated Measures
Comparison: General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 3p-value: 0.217795% CI: [-0.4, 0.1]Mixed Model for Repeated Measures
Comparison: General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 8p-value: 0.2395% CI: [-0.4, 0.1]Mixed Model for Repeated Measures
Comparison: General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 15p-value: 0.000195% CI: [-0.7, -0.2]Mixed Model for Repeated Measures
Comparison: General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 21p-value: 0.015195% CI: [-0.5, -0.1]Mixed Model for Repeated Measures
Comparison: General Somatic Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 45p-value: 0.050295% CI: [-0.5, 0]Mixed Model for Repeated Measures
Comparison: Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 3p-value: 0.365995% CI: [-0.3, 0.1]Mixed Model for Repeated Measures
Comparison: Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 8p-value: 0.600395% CI: [-0.3, 0.2]Mixed Model for Repeated Measures
Comparison: Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 15p-value: 0.078595% CI: [-0.5, 0]Mixed Model for Repeated Measures
Comparison: Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 21p-value: 0.366895% CI: [-0.4, 0.1]Mixed Model for Repeated Measures
Comparison: Genital Symptoms: Change From Baseline in HAM-D Individual Item Score at Day 45p-value: 0.182795% CI: [-0.4, 0.1]Mixed Model for Repeated Measures
Comparison: Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 3p-value: 0.132795% CI: [-0.4, 0.1]Mixed Model for Repeated Measures
Comparison: Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 8p-value: 0.099395% CI: [-0.4, 0]Mixed Model for Repeated Measures
Comparison: Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 15p-value: 0.000295% CI: [-0.6, -0.2]Mixed Model for Repeated Measures
Comparison: Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 21p-value: 0.005695% CI: [-0.5, -0.1]Mixed Model for Repeated Measures
Comparison: Hypochondriasis: Change From Baseline in HAM-D Individual Item Score at Day 45p-value: 0.012295% CI: [-0.5, -0.1]Mixed Model for Repeated Measures
Comparison: Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 3p-value: 0.130595% CI: [-0.3, 0]Mixed Model for Repeated Measures
Comparison: Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 8p-value: 0.663895% CI: [-0.2, 0.1]Mixed Model for Repeated Measures
Comparison: Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 15p-value: 0.434195% CI: [-0.2, 0.1]Mixed Model for Repeated Measures
Comparison: Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 21p-value: 0.908595% CI: [-0.1, 0.1]Mixed Model for Repeated Measures
Comparison: Loss of Weight According to Patient: Change From Baseline in HAM-D Individual Item Score at Day 45p-value: 0.18295% CI: [-0.3, 0.1]Mixed Model for Repeated Measures
Comparison: Insight: Change From Baseline in HAM-D Individual Item Score at Day 3p-value: 0.159395% CI: [-0.1, 0]Mixed Model for Repeated Measures
Comparison: Insight: Change From Baseline in HAM-D Individual Item Score at Day 8p-value: 0.655595% CI: [-0.1, 0]Mixed Model for Repeated Measures
Comparison: Insight: Change From Baseline in HAM-D Individual Item Score at Day 15p-value: 0.01795% CI: [-0.1, 0]Mixed Model for Repeated Measures
Comparison: Insight: Change From Baseline in HAM-D Individual Item Score at Day 21p-value: 0.018895% CI: [-0.1, 0]Mixed Model for Repeated Measures
Comparison: Insight: Change From Baseline in HAM-D Individual Item Score at Day 45p-value: 0.072695% CI: [-0.2, 0]Mixed Model for Repeated Measures
Secondary
Parts A and B: Change From Baseline in HAM-D Subscales Scores
HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. HAM-D subscales: Core subscale (symptoms-depressed mood, feelings of guilt, suicide, work and activities, and retardation ); Anxiety subscale (symptoms-anxiety \[psychic and somatic\], somatic symptoms \[gastrointestinal and general\], hypochondriasis, loss of weight); Bech-6 subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, anxiety psychic, and somatic symptoms general); Meier subscale (symptoms-depressed mood, feelings of guilt, work and activities, retardation, agitation, and anxiety psychic). Each item was scored in a range of 0 to 2 or 0 to 4, higher scores=greater degree of depression. Subscale scores were calculated as the sum of the individual item scores comprising each subscale. Scores were transformed to a scale of 0 to 100, with higher scores indicated more severe depression. A negative change from Baseline indicates less depression.
Time frame: Part B: Baseline, Days 3, 8, 15, 21 and 45
Population: Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Core: Change From Baseline at Day 3 | -16.7 score on a scale | Standard Error 1.91 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Core: Change From Baseline at Day 8 | -23.4 score on a scale | Standard Error 2.03 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Core: Change From Baseline at Day 15 | -26.8 score on a scale | Standard Error 2.1 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Core: Change From Baseline at Day 21 | -27.3 score on a scale | Standard Error 2.24 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Core: Change From Baseline at Day 45 | -29.5 score on a scale | Standard Error 2.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Anxiety: Change From Baseline at Day 3 | -16.4 score on a scale | Standard Error 1.98 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Anxiety: Change From Baseline at Day 21 | -27.3 score on a scale | Standard Error 2.17 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Anxiety: Change From Baseline at Day 45 | -26.5 score on a scale | Standard Error 2.19 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Bech-6: Change From Baseline at Day 21 | -32.7 score on a scale | Standard Error 2.72 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Meier: Change From Baseline at Day 3 | -17.0 score on a scale | Standard Error 2.17 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Anxiety: Change From Baseline at Day 8 | -23.2 score on a scale | Standard Error 2.15 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Anxiety: Change From Baseline at Day 15 | -23.4 score on a scale | Standard Error 2.19 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Bech-6: Change From Baseline at Day 3 | -19.5 score on a scale | Standard Error 2.45 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Bech-6: Change From Baseline at Day 8 | -28.3 score on a scale | Standard Error 2.58 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Bech-6: Change From Baseline at Day 15 | -30.9 score on a scale | Standard Error 2.61 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Bech-6: Change From Baseline at Day 45 | -34.6 score on a scale | Standard Error 2.61 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Meier: Change From Baseline at Day 8 | -25.0 score on a scale | Standard Error 2.3 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Meier: Change From Baseline at Day 15 | -28.1 score on a scale | Standard Error 2.35 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Meier: Change From Baseline at Day 21 | -29.9 score on a scale | Standard Error 2.42 |
| Part B: Placebo | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Meier: Change From Baseline at Day 45 | -31.5 score on a scale | Standard Error 2.32 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Meier: Change From Baseline at Day 3 | -21.7 score on a scale | Standard Error 2.13 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Core: Change From Baseline at Day 3 | -18.8 score on a scale | Standard Error 1.88 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Anxiety: Change From Baseline at Day 15 | -33.2 score on a scale | Standard Error 2.13 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Anxiety: Change From Baseline at Day 45 | -34.5 score on a scale | Standard Error 2.11 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Meier: Change From Baseline at Day 45 | -41.0 score on a scale | Standard Error 2.25 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Core: Change From Baseline at Day 21 | -33.7 score on a scale | Standard Error 2.2 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Bech-6: Change From Baseline at Day 3 | -23.7 score on a scale | Standard Error 2.41 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Meier: Change From Baseline at Day 8 | -32.2 score on a scale | Standard Error 2.24 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Anxiety: Change From Baseline at Day 3 | -23.5 score on a scale | Standard Error 1.93 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Bech-6: Change From Baseline at Day 8 | -34.9 score on a scale | Standard Error 2.53 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Anxiety: Change From Baseline at Day 21 | -33.3 score on a scale | Standard Error 2.11 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Meier: Change From Baseline at Day 21 | -37.0 score on a scale | Standard Error 2.37 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Bech-6: Change From Baseline at Day 15 | -39.2 score on a scale | Standard Error 2.56 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Bech-6: Change From Baseline at Day 21 | -40.7 score on a scale | Standard Error 2.68 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Meier: Change From Baseline at Day 15 | -35.5 score on a scale | Standard Error 2.3 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Core: Change From Baseline at Day 8 | -28.7 score on a scale | Standard Error 1.99 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Core: Change From Baseline at Day 15 | -31.9 score on a scale | Standard Error 2.06 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Core: Change From Baseline at Day 45 | -37.2 score on a scale | Standard Error 2.05 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Bech-6: Change From Baseline at Day 45 | -44.0 score on a scale | Standard Error 2.54 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in HAM-D Subscales Scores | Anxiety: Change From Baseline at Day 8 | -29.8 score on a scale | Standard Error 2.09 |
Comparison: Core: Change from Baseline in HAM-D Subscale Score at Day 3p-value: 0.383295% CI: [-6.9, 2.7]Mixed Model for Repeated Measures
Comparison: Core: Change from Baseline in HAM-D Subscale Score at Day 8p-value: 0.041595% CI: [-10.5, -0.2]Mixed Model for Repeated Measures
Comparison: Core: Change from Baseline in HAM-D Subscale Score at Day 15p-value: 0.060695% CI: [-10.5, 0.2]Mixed Model for Repeated Measures
Comparison: Core: Change from Baseline in HAM-D Subscale Score at Day 21p-value: 0.031895% CI: [-12.1, -0.6]Mixed Model for Repeated Measures
Comparison: Core: Change from Baseline in HAM-D Subscale Score at Day 45p-value: 0.004795% CI: [-13, -2.4]Mixed Model for Repeated Measures
Comparison: Anxiety: Change from Baseline in HAM-D Subscale Score at Day 3p-value: 0.005395% CI: [-12, -2.1]Mixed Model for Repeated Measures
Comparison: Anxiety: Change from Baseline in HAM-D Subscale Score at Day 8p-value: 0.018195% CI: [-12.1, -1.1]Mixed Model for Repeated Measures
Comparison: Anxiety: Change from Baseline in HAM-D Subscale Score at Day 15p-value: 0.000795% CI: [-15.3, -4.2]Mixed Model for Repeated Measures
Comparison: Anxiety: Change from Baseline in HAM-D Subscale Score at Day 21p-value: 0.033295% CI: [-11.5, -0.5]Mixed Model for Repeated Measures
Comparison: Anxiety: Change from Baseline in HAM-D Subscale Score at Day 45p-value: 0.004895% CI: [-13.5, -2.5]Mixed Model for Repeated Measures
Comparison: Bech-6: Change from Baseline in HAM-D Subscale Score at Day 3p-value: 0.18495% CI: [-10.3, 2]Mixed Model for Repeated Measures
Comparison: Bech-6: Change from Baseline in HAM-D Subscale Score at Day 8p-value: 0.046295% CI: [-13.2, -0.1]Mixed Model for Repeated Measures
Comparison: Bech-6: Change from Baseline in HAM-D Subscale Score at Day 15p-value: 0.01595% CI: [-14.9, -1.6]Mixed Model for Repeated Measures
Comparison: Bech-6: Change from Baseline in HAM-D Subscale Score at Day 21p-value: 0.024595% CI: [-15, -1]Mixed Model for Repeated Measures
Comparison: Bech-6: Change from Baseline in HAM-D Subscale Score at Day 45p-value: 0.005495% CI: [-16, -2.8]Mixed Model for Repeated Measures
Comparison: Meier: Change from Baseline in HAM-D Subscale Score at Day 3p-value: 0.097295% CI: [-10.1, 0.9]Mixed Model for Repeated Measures
Comparison: Meier: Change from Baseline in HAM-D Subscale Score at Day 8p-value: 0.015595% CI: [-13.1, -1.4]Mixed Model for Repeated Measures
Comparison: Meier: Change from Baseline in HAM-D Subscale Score at Day 15p-value: 0.014995% CI: [-13.4, -1.5]Mixed Model for Repeated Measures
Comparison: Meier: Change from Baseline in HAM-D Subscale Score at Day 21p-value: 0.02595% CI: [-13.3, -0.9]Mixed Model for Repeated Measures
Comparison: Meier: Change from Baseline in HAM-D Subscale Score at Day 45p-value: 0.001795% CI: [-15.3, -3.6]Mixed Model for Repeated Measures
Secondary
Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score
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). The individual items were scored in a range of 0 (not present) to 4 (very severe). The HAM-A total score was calculated as the sum of the 14 individual item scores and could range from 0 to 56 where a score of \<17=mild severity; 18-24= mild to moderate severity and 25-30=moderate to severe severity. A negative change from Baseline indicates less anxiety.
Time frame: Part B: Baseline, Days 3, 8, 15, 21 and 45
Population: Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Part B: Placebo | Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Change From Baseline at Day 8 | -11.7 score on a scale | Standard Error 1.04 |
| Part B: Placebo | Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Change From Baseline at Day 21 | -13.1 score on a scale | Standard Error 1.07 |
| Part B: Placebo | Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Change From Baseline at Day 15 | -12.7 score on a scale | Standard Error 1.09 |
| Part B: Placebo | Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Change From Baseline at Day 45 | -13.6 score on a scale | Standard Error 1.02 |
| Part B: Placebo | Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Change From Baseline at Day 3 | -8.9 score on a scale | Standard Error 1.02 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Change From Baseline at Day 45 | -18.6 score on a scale | Standard Error 0.99 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Change From Baseline at Day 3 | -12.0 score on a scale | Standard Error 0.99 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Change From Baseline at Day 8 | -16.1 score on a scale | Standard Error 1.01 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Change From Baseline at Day 15 | -16.6 score on a scale | Standard Error 1.07 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Change From Baseline at Day 21 | -16.6 score on a scale | Standard Error 1.05 |
Comparison: Change from Baseline in HAM-A Total Score at Day 3p-value: 0.016995% CI: [-5.7, -0.6]Mixed Model for Repeated Measures
Comparison: Change from Baseline in HAM-A Total Score at Day 8p-value: 0.00195% CI: [-7, -1.8]Mixed Model for Repeated Measures
Comparison: Change from Baseline in HAM-A Total Score at Day 15p-value: 0.006395% CI: [-6.7, -1.1]Mixed Model for Repeated Measures
Comparison: Change from Baseline in HAM-A Total Score at Day 21p-value: 0.011995% CI: [-6.2, -0.8]Mixed Model for Repeated Measures
Comparison: Change from Baseline in HAM-A Total Score at Day 45p-value: 0.000295% CI: [-7.5, -2.4]Mixed Model for Repeated Measures
Secondary
Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score
The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.
Time frame: Part B: Baseline, Days 3, 8, 15, 21 and 45
Population: Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Part B: Placebo | Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score | Change From Baseline at Day 8 | -16.3 score on a scale | Standard Error 1.45 |
| Part B: Placebo | Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score | Change From Baseline at Day 21 | -17.8 score on a scale | Standard Error 1.49 |
| Part B: Placebo | Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score | Change From Baseline at Day 3 | -11.7 score on a scale | Standard Error 1.36 |
| Part B: Placebo | Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score | Change From Baseline at Day 45 | -19.0 score on a scale | Standard Error 1.44 |
| Part B: Placebo | Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score | Change From Baseline at Day 15 | -17.6 score on a scale | Standard Error 1.48 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score | Change From Baseline at Day 45 | -24.8 score on a scale | Standard Error 1.39 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score | Change From Baseline at Day 3 | -14.8 score on a scale | Standard Error 1.33 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score | Change From Baseline at Day 8 | -20.3 score on a scale | Standard Error 1.42 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score | Change From Baseline at Day 15 | -22.1 score on a scale | Standard Error 1.45 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in Montgomery and Åsberg Depression Rating Scale (MADRS) Total Score | Change From Baseline at Day 21 | -22.1 score on a scale | Standard Error 1.46 |
Comparison: Change From Baseline in MADRS Total Score at Day 3p-value: 0.079195% CI: [-6.5, 0.4]Mixed Model for Repeated Measures
Comparison: Change From Baseline in MADRS Total Score at Day 8p-value: 0.03221.86% CI: [-7.7, -0.3]Mixed Model for Repeated Measures
Comparison: Change From Baseline in MADRS Total Score at Day 15p-value: 0.01895% CI: [-8.3, -0.8]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MADRS Total Score at 21p-value: 0.027195% CI: [-8.1, -0.5]Mixed Model for Repeated Measures
Comparison: Change from Baseline in MADRS Total Score at 45p-value: 0.001895% CI: [-9.4, -2.2]Mixed Model for Repeated Measures
Secondary
Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45
The 17-item HAM-D is used to rate the severity of depression in participants who are already diagnosed as depressed. Items scored in a range of 0 to 2 include: insomnia (early, middle, late), somatic symptoms (gastrointestinal and general), genital symptoms, loss of weight, and insight. The following items are 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 HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. Higher scores indicated more severe depression. A negative change from Baseline indicates less depression.
Time frame: Part B: Baseline, Days 3, 8, 21 and 45
Population: Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Part B: Placebo | Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Change From Baseline at Day 3 | -9.8 score on a scale | Standard Error 0.95 |
| Part B: Placebo | Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Change From Baseline at Day 8 | -12.9 score on a scale | Standard Error 1.03 |
| Part B: Placebo | Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Change From Baseline at Day 21 | -14.4 score on a scale | Standard Error 1.11 |
| Part B: Placebo | Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Change From Baseline at Day 45 | -15.1 score on a scale | Standard Error 1.06 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Change From Baseline at Day 45 | -19.2 score on a scale | Standard Error 1.02 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Change From Baseline at Day 3 | -12.5 score on a scale | Standard Error 0.93 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Change From Baseline at Day 21 | -17.6 score on a scale | Standard Error 1.09 |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Change From Baseline in the HAM-D Total Score at Days 3, 8, 21 and 45 | Change From Baseline at Day 8 | -16.3 score on a scale | Standard Error 1 |
Comparison: Change From Baseline in the HAM-D Total Score at Day 3p-value: 0.025295% CI: [-5.1, -0.3]Mixed Model for Repeated Measures
Comparison: Change From Baseline in the HAM-D Total Score at Day 8p-value: 0.010695% CI: [-6, -0.8]Mixed Model for Repeated Measures
Comparison: Change From Baseline in the HAM-D Total Score at Day 21p-value: 0.032195% CI: [-6, -0.3]Mixed Model for Repeated Measures
Comparison: Change From Baseline in the HAM-D Total Score at Day 45p-value: 0.002795% CI: [-6.7, -1.4]Mixed Model for Repeated Measures
Secondary
Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
An Adverse Event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE was defined as an AE with an onset that occurs after receiving study drug.
Time frame: Part A: Up to Day 75; Part B: Up to Day 45
Population: Part A: All randomized participants; Part B: Safety Set included all participants who were administered study drug in Part B of the study and analyzed as per actual treatment received.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Part A: SAGE-217 15/20 mg Oral Solution | Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 1 Participants |
| Part B: Placebo | Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 38 Participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 47 Participants |
Secondary
Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response
The Clinical Global Impression - Improvement (CGI-I) item of the CGI scale uses a 7-point Likert scale to measure the overall improvement in the participant's condition posttreatment. 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. CGI response was defined as a CGI-I score of 1 (very much improved) or 2 (much improved). The percentage of participants with overall improvement in post-treatment condition, rated by investigator as very much improved (CGI-I score of 1) or much improved (CGI-I score of 2) is reported.
Time frame: Part B: Days 3, 8, 15, 21 and 45
Population: Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part B: Placebo | Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Day 8 | 50.0 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Day 21 | 54.8 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Day 15 | 52.1 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Day 45 | 55.9 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Day 3 | 28.4 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Day 45 | 71.2 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Day 3 | 37.8 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Day 8 | 65.3 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Day 15 | 71.6 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With Clinical Global Impression - Improvement (CGI-I) Response | Day 21 | 70.3 percentage of participants |
Comparison: Percentage of Participants With CGI-I Response at Day 3p-value: 0.337295% CI: [0.7, 2.81]GEE for binary response model
Comparison: Percentage of Participants With CGI-I Response at Day 8p-value: 0.093595% CI: [0.91, 3.47]GEE for binary response model
Comparison: Percentage of Participants With CGI-I Response at Day 15p-value: 0.027695% CI: [1.09, 4.28]GEE for binary response model
Comparison: Percentage of Participants With CGI-I Response at Day 21p-value: 0.09295% CI: [0.91, 3.54]GEE for binary response model
Comparison: Percentage of Participants With CGI-I Response at Day 45p-value: 0.110995% CI: [0.88, 3.51]GEE for binary response model
Secondary
Parts A and B: Percentage of Participants With HAM-D Remission
HAM-D Remission was defined as a HAM-D total score of less than or equal to (\<=)7. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours \[morning\]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.
Time frame: Part B: Days 3, 8, 15, 21 and 45
Population: Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part B: Placebo | Parts A and B: Percentage of Participants With HAM-D Remission | Day 8 | 18.9 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With HAM-D Remission | Day 15 | 23.3 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With HAM-D Remission | Day 21 | 28.8 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With HAM-D Remission | Day 45 | 30.4 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With HAM-D Remission | Day 3 | 5.4 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With HAM-D Remission | Day 3 | 18.9 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With HAM-D Remission | Day 45 | 53.4 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With HAM-D Remission | Day 15 | 44.6 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With HAM-D Remission | Day 8 | 32.0 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With HAM-D Remission | Day 21 | 41.9 percentage of participants |
Comparison: Percentage of Participants With HAM-D Remission at Day 3p-value: 0.0295% CI: [1.24, 12.23]GEE for binary response model
Comparison: Percentage of Participants With HAM-D Remission at Day 8p-value: 0.09995% CI: [0.89, 4.13]GEE for binary response model
Comparison: Percentage of Participants With HAM-D Remission at Day 15p-value: 0.01195% CI: [1.24, 5.17]GEE for binary response model
Comparison: Percentage of Participants With HAM-D Remission at Day 21p-value: 0.198295% CI: [0.79, 3.19]GEE for binary response model
Comparison: Percentage of Participants With HAM-D Remission at Day 45p-value: 0.009195% CI: [1.26, 5.03]GEE for binary response model
Secondary
Parts A and B: Percentage of Participants With HAM-D Response
HAM-D Response was defined as having a 50 percent (%) or greater reduction from Baseline in HAM-D total score. The HAM-D total score was calculated as the sum of the 17 individual item scores and could range from 0 to 52. The items on HAM-D included: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early night, middle night, early hours \[morning\]), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. Higher scores indicated more depression.
Time frame: Part B: Days 3, 8, 15, 21 and 45
Population: Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part B: Placebo | Parts A and B: Percentage of Participants With HAM-D Response | Day 8 | 44.6 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With HAM-D Response | Day 21 | 56.2 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With HAM-D Response | Day 15 | 47.9 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With HAM-D Response | Day 45 | 56.5 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With HAM-D Response | Day 3 | 27.0 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With HAM-D Response | Day 45 | 75.3 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With HAM-D Response | Day 3 | 40.5 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With HAM-D Response | Day 8 | 65.3 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With HAM-D Response | Day 15 | 71.6 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With HAM-D Response | Day 21 | 71.6 percentage of participants |
Comparison: Percentage of Participants With HAM-D Response at Day 3p-value: 0.100495% CI: [0.89, 3.6]GEE for binary response model
Comparison: Percentage of Participants With HAM-D Response at Day 8p-value: 0.012795% CI: [1.2, 4.45]GEE for binary response model
Comparison: Percentage of Participants With HAM-D Response at Day 15p-value: 0.004995% CI: [1.34, 5.16]GEE for binary response model
Comparison: Percentage of Participants With HAM-D Response at Day 21p-value: 0.076395% CI: [0.94, 3.64]GEE for binary response model
Comparison: Percentage of Participants With HAM-D Response at Day 45p-value: 0.021695% CI: [1.13, 4.6]GEE for binary response model
Secondary
Parts A and B: Percentage of Participants With MADRS Remission
MADRS Remission was defined as a MADRS total score of \<=10. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression.
Time frame: Part B: Days 3, 8, 15, 21 and 45
Population: Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part B: Placebo | Parts A and B: Percentage of Participants With MADRS Remission | Day 15 | 30.1 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With MADRS Remission | Day 8 | 28.4 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With MADRS Remission | Day 45 | 37.7 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With MADRS Remission | Day 21 | 31.5 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With MADRS Remission | Day 3 | 9.5 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With MADRS Remission | Day 3 | 24.3 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With MADRS Remission | Day 15 | 54.1 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With MADRS Remission | Day 21 | 52.7 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With MADRS Remission | Day 8 | 37.3 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With MADRS Remission | Day 45 | 58.9 percentage of participants |
Comparison: Percentage of Participants With MADRS Remission at Day 3p-value: 0.032695% CI: [1.09, 7.38]GEE for binary response model
Comparison: Percentage of Participants With MADRS Remission at Day 8p-value: 0.374995% CI: [0.68, 2.79]GEE for binary response model
Comparison: Percentage of Participants With MADRS Remission at Day 15p-value: 0.008795% CI: [1.26, 4.92]GEE for binary response model
Comparison: Percentage of Participants With MADRS Remission at Day 21p-value: 0.025795% CI: [1.1, 4.31]GEE for binary response model
Comparison: Percentage of Participants With MADRS Remission at Day 45p-value: 0.033995% CI: [1.06, 4.09]GEE for binary response model
Secondary
Parts A and B: Percentage of Participants With MADRS Response
MADRS response was defined as having a 50% or greater reduction from Baseline in MADRS total score. The MADRS is a 10-item questionnaire used to measure the severity of depressive episodes in participants with mood disorders. It includes questions on the following symptoms: apparent sadness; reported sadness; inner tension; reduced sleep; reduced appetite; concentration difficulties; lassitude; inability to feel; pessimistic thoughts; and suicidal thoughts. Each item was scored in a range of 0 (no symptoms) to 6 (symptoms of maximum severity). The MADRS total score was calculated as the sum of the 10 individual item scores and could range from 0 to 60. Higher scores indicated more depression.
Time frame: Part B: Days 3, 8, 15, 21 and 45
Population: Only 1 participant was enrolled and treated in the Part A: SAGE-217 15/20 mg Oral Solution arm group and due to low number of participants, no efficacy analyses were conducted for Part A of the study. Part B: Efficacy Set included all participants who were administered study drug, had a valid Baseline and at least 1 post-baseline efficacy assessment. Here, 'number analyzed' signifies participants evaluable for this outcome measure at specified time points.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Part B: Placebo | Parts A and B: Percentage of Participants With MADRS Response | Day 15 | 47.9 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With MADRS Response | Day 45 | 56.5 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With MADRS Response | Day 8 | 50.0 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With MADRS Response | Day 3 | 27.0 percentage of participants |
| Part B: Placebo | Parts A and B: Percentage of Participants With MADRS Response | Day 21 | 52.1 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With MADRS Response | Day 8 | 64.0 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With MADRS Response | Day 15 | 73.0 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With MADRS Response | Day 21 | 70.3 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With MADRS Response | Day 45 | 74.0 percentage of participants |
| Part B: SAGE 217 30 mg Capsules | Parts A and B: Percentage of Participants With MADRS Response | Day 3 | 40.5 percentage of participants |
Comparison: Percentage of Participants With MADRS Response at Day 3p-value: 0.114595% CI: [0.87, 3.53]GEE for binary response model
Comparison: Percentage of Participants With MADRS Response at Day 8p-value: 0.106995% CI: [0.89, 3.3]GEE for binary response model
Comparison: Percentage of Participants With MADRS Response at Day 15p-value: 0.004595% CI: [1.36, 5.27]GEE for binary response model
Comparison: Percentage of Participants With MADRS Response at Day 21p-value: 0.042195% CI: [1.03, 3.93]GEE for binary response model
Comparison: Percentage of Participants With MADRS Response at Day 45p-value: 0.054195% CI: [0.99, 4.03]GEE for binary response model