Bipolar Disorder
Conditions
Keywords
Bipolar I Disorder with a recent manic or mixed episode
Brief summary
The purpose of this clinical research study is to learn if outpatients with bipolar mania who are partially nonresponsive to lithium or valproate monotherapy can achieve stable symptoms on a combination treatment of aripiprazole plus lithium or valproate.
Interventions
DRUGLithium or Valproate with placebo (PBO)
Tablets, Oral, once daily lithium 250-2100 mg/day valproate 250-2500mg/day Placebo once daily
DRUGLithium or Valproate with Aripiprazole
Tablets, Oral, once daily, 52 weeks post randomization (Pre-Randomization Phases 13-24 weeks) lithium 250-2100 mg/day valproate 250-2500mg/day aripiprazole 15-30 mg/day
Sponsors
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women \> or = to 18 years of age meeting Diagnostic and Statistical Manual for Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for bipolar I disorder, currently experiencing a manic or mixed episode with a history of one or more manic or mixed episodes or sufficient severity to require hospitalization and/or treatment with a mood stabilizer or antipsychotic.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: hospitalization for a manic, mixed or depressive episode; serious adverse event of worsening disease under study accompanied by a Y-MRS \> 16 and/or a MADRS \> 16; discontinuation due to lack of efficacy as determined by the investigator accompanied by a Y-MRS \> 16 and/or a MADRS \> 16. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3 | Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: relapse is defined as any of the following events accompanied by a Young-Mania Rating Scale (Y-MRS) \>16 and/or a Montgomery Åsberg Depression Rating Scale (MADRS) \>16; serious adverse event of worsening disease, or discontinuation by the investigator for lack of efficacy. A hospitalization for a manic, mixed, or depressive episode does meet the criteria for relapse, however does not require an accompanying Y-MRS and/or MADRS score \>16. |
| Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3 | Kaplan Meier estimated survival rate. Relapse is defined as any of the following events accompanied by a YMRS \> 16 and/or a MADRS \> 16; serious adverse event of worsening disease, or discontinuation by the investigator for lack of efficacy. A hospitalization for a manic, mixed, or depressive episode does meet the criteria for relapse, however does not require an accompanying Y-MRS and/or MADRS score \> 16. |
| Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Baseline (end of ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 (Ph2) Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, + Confirmation of Partial Nonresponse Phase) | The Y-MRS consists of 11 items: 1) Elevated Mood, 2) Increased Motor Activity -Energy, 3) Sexual Interest, 4) Sleep, 5) Irritability, 6) Speech (Rate and Amount), 7) Language -Thought Disorder, 8) Content, 9) Disruptive-Aggressive Behavior, 10) Appearance, 11) Insight. Seven items are rated on a 0 to 4 scale, while 4 items (items 5, 6, 8 and 9) are rated on a 0 to 8 scale (twice the weight of the other items.) For all items, 0 is the best rating and 4 or 8 is the worst rating. Total Score is the sum of the ratings for all 11 items. The possible Total Scores are from 0 (best) to 60 (worst). |
| Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | The Y-MRS consists of 11 items: 1) Elevated Mood, 2) Increased Motor Activity -Energy, 3) Sexual Interest, 4) Sleep, 5) Irritability, 6) Speech (Rate and Amount), 7) Language -Thought Disorder, 8) Content, 9) Disruptive-Aggressive Behavior, 10) Appearance, 11) Insight. 7 items are rated on a 0 to 4 scale, while 4 items (items 5, 6, 8 and 9) are rated on a 0 to 8 scale (twice the weight of the other items.) For all items, 0 is the best rating and 4 or 8 is the worst rating. Total Score is the sum of the ratings for all 11 items. The possible Total Scores are from 0 (best) to 60 (worst). |
| Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Baseline (end of Ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 (Ph2) Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement. |
| Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement. |
| Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Baseline (end of Ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. |
| Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. |
| Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Baseline (end of Ph 1), Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from baseline (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. |
| Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. |
| Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall change from preceding phase items on a 7-point scale \[1 to 7\], with 1 being very much improved and 7 being very much worse). |
| Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Baseline (end of Ph 1), Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from baseline (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. |
| Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. |
| Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being very much improved and 7 being very much worse). |
| Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale \[1 to 7\], with 1 being very much improved and 7 being very much worse). |
| Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale \[1 to 7\], with 1 being very much improved and 7 being very much worse). |
| Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale \[1 to 7\], with 1 being very much improved and 7 being very much worse). |
| Number of Participants Maintaining Remission During Phase 3 | Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Remission is defined as Y-MRS Total Score \<=12 and MADRS Total Score \<=12. |
| Proportion of Participants Discontinuing For Any Reason Through Week 52 (During Phase 3) | Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | — |
| Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2 | During Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase) | Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. |
| Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2 | During Phase 2. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death). |
| Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase) | Sinus Tachycardia: ≥120bpm+↑≥15bpm+no current diagnosis of supraventricular (SV) or ventricular tachycardia or atrial fibrillation (AF) or flutter or other rhythm abnormality (RA). Sinus Bradycardia:≥50bpm+↓≥15bpm+no current diagnosis of AF or flutter or other RA. AF:not present→present or present at rate \<100bpm pretreatment to present with rate ≥100bpm+increase of ≥15bpm. AV=atrioventricular; PR=PR interval. Other Intraventricular Block: QRS wave ≥0.12 sec+↑≥0.02 sec+no current diagnosis of left or right bundle branch block. Old Infarction not present→present at ≥12 weeks post study entry. |
| Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase) | Heart Rate: increase, ≥120 beats per minute (bpm) and ≥15 relative to baseline (RBL); decrease, ≤50 bpm and ≥15 RBL. Systolic BP: increase, ≥180 mmHg and ≥20 RBL; decrease, ≤90 mmHg and ≥20 RBL. Diastolic BP: increase, ≥105 mmHg and ≥15 RBL; decrease, ≤50 mmHg and ≥15 RBL. For patients missing a baseline value, an on-treatment value was considered potentially clinically relevant if the value meets the criterion value. |
| Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase) | ULN=upper limit of normal; HDL=high density lipoprotein; LDL=low density lipoprotein. Values for ULN are provided by the lab in the database and could be different for each individual patient based on characteristics such as age, gender, or other patient attributes. |
| Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase) | — |
| Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2 | Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase) | — |
| Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase) | — |
| Median Baseline and Change From Baseline in Weight Vital Sign Measurements At Phase 2 Endpoint | Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase) | — |
| Median Baseline and Change From Baseline in Body Mass Index (BMI) Vital Sign Measurements at Phase 2 Endpoint | Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | — |
| Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample | Baseline | — |
| Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2 | Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | — |
| Median Baseline and Change From Baseline in Heart Rate Measurements During Phase 2 | Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase) | — |
| Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | Baseline | — |
| Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | — |
| Median Baseline Eosinophils (Relative) and Neutrophils (Relative) | Baseline | — |
| Median Change From Baseline in Eosinophils (Relative) and Neutrophils (Relative) | Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | — |
| Median Baseline Hemoglobin | Baseline | — |
| Median Change From Baseline in Hemoglobin | Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | — |
| Median Baseline Hematocrit | Baseline | — |
| Median Change From Baseline in Hematocrit | Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | — |
| Median Baseline Homeostasis Model Assessment 2 (HOMA2)-Percent Beta | Baseline | HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of 'normal function.' |
| Median Baseline Homeostasis Model Assessment 2 HOMA2-Insulin Resistance (IR) | Baseline | HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.' |
| Median Change From Baseline in Homeostasis Model Assessment 2(HOMA2)-Percent Beta at Phase 2 Endpoint | Baseline (end of Ph 1), Phase 2 Endpoint (endpoint of a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase) | HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of 'normal function.' |
| Median Change From Baseline in HOMA2 Model Assesses Insulin Resistance (HOMA2-IR) at Phase 2 Endpoint | Baseline (end of Ph 1), Phase 2 Endpoint (endpoint of a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase) | HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.' |
| Median Baseline Platelet Count | Baseline | — |
| Median Change From Baseline in Platelet Count at Phase 2 Endpoint | Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | — |
| Median Baseline Prolactin | Baseline | — |
| Median Change From Baseline in Prolactin at Phase 2 Endpoint | Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | — |
| Median Baseline Leukocytes | Baseline | — |
| Median Change From Baseline in Leukocytes at Phase 2 Endpoint | Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | — |
| Baseline Abnormal Involuntary Movement Scale (AIMS) | Baseline | The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction. |
| Unadjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) at Phase 2 Endpoint | Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction. |
| Baseline in Simpson-Angus Scale (SAS) Total Score | Baseline | The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50.(lower score=less severe). Negative change scores indicate improvement. |
| Unadjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score at Phase 2 Endpoint | Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower score=less severe). Negative change scores indicate improvement. |
| Baseline in Barnes Akathisia Global Clinical Assessment | Baseline | The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia. |
| Unadjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Phase 2 Endpoint | Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase) | The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia. |
| Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3 | Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. |
| Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death). |
| Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Heart Rate: increase, ≥120 beats per minute (bpm) and ≥15 relative to baseline (RBL); decrease, ≤50 bpm and ≥15 RBL. Systolic BP: increase, ≥180 mmHg and ≥20 RBL; decrease, ≤90 mmHg and ≥20 RBL. Diastolic BP: increase, ≥105 mmHg and ≥15 RBL; decrease, ≤50 mmHg and ≥15 RBL. For patients missing a baseline value, an on-treatment value was considered potentially clinically relevant if the value meets the criterion value. |
| Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3 | Baseline, During Phase 3 (for highest/lowest values), Week 52 | — |
| Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3 | Baseline, During Phase 3 (for highest/lowest values), Week 52 | — |
| Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3 | Baseline, During Phase 3 (for highest/lowest values), Week 52 | — |
| Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3 | Baseline, During Phase 3 (for highest/lowest values), Week 52 | — |
| Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3 | Baseline, During Phase 3 (for highest/lowest values), Week 52 | — |
| Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3 | Baseline, During Phase 3 (for highest/lowest values), Week 52 | — |
| Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3 | Baseline, During Phase 3 (for highest/lowest values), Week 52 | — |
| Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3 | Baseline, During Phase 3 (for highest/lowest values), Week 52 | — |
| Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3 | Baseline, During Phase 3 (for highest/lowest values), Week 52 | — |
| Baseline and Adjusted Mean Change From Baseline in Weight | Baseline, Weeks 12, 24, 36, 52, During Phase 3 (for highest value) | — |
| Number of Participants Showing Relevant Weight Gain During Phase 3 | Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment) | Relevant weight gain: \>=7% increase from baseline |
| Number of Participants Showing Relevant Weight Loss During Phase 3 | Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment) | Relevant weight loss: \>=7% decrease from baseline |
| Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 | Baseline, Week 12, Week 24, Week 36, Week 52, Week 52 (LOCF), During Phase 3 (for lowest/highest values) | — |
| Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | ULN=upper limit of normal; Hb=hemoglobin |
| Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | The change values reported are the median of (post baseline percentage (of white blood cell count) minus baseline percentage (of white blood cell count). |
| Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value) | — |
| Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value) | — |
| Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value | — |
| Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value | HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of 'normal function.' |
| Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value | HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.' |
| Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value) | — |
| Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value) | — |
| Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Sinus Tachycardia: ≥120bpm+↑≥15bpm+no current diagnosis of supraventricular (SV) or ventricular tachycardia or atrial fibrillation (AF) or flutter or other rhythm abnormality (RA). Sinus Bradycardia:≥50bpm+↓≥15bpm+no current diagnosis of AF or flutter or other RA. AF:not present→present or present at rate \<100bpm pretreatment to present with rate ≥100bpm+increase of ≥15bpm. AV=atrioventricular; PR=PR interval. Other Intraventricular Block: QRS wave ≥0.12 sec+↑≥0.02 sec+no current diagnosis of left or right bundle branch block. Old Infarction not present→present at ≥12 weeks post study entry. |
| Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Baseline, Weeks 4,8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change) | The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower scores=less severe). Negative change scores indicate improvement. |
| Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample | Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value) | — |
| Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change) | The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction. |
| Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change) | The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 8 Score range from 0 to 4. A negative score signifies improvement. |
| Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change) | The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 9 Score range from 0 to 4. A negative score signifies improvement. |
| Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Baseline (end of Phase 2), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. |
| Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change) | The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia. |
| Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3 | Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | — |
| Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 of LTE Phase. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. |
| Extension Phase: Mean Change From Baseline in CGI-BP (Mania) Severity of Illness at Extension Phase Endpoint | Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. |
| Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Depression) at Extension Phase Endpoint | Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. |
| Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. |
| Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. |
| Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Overall) at Extension Phase Endpoint | Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement. |
| Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations | From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event. |
| Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Metabolic abnormalities considered by the investigator as clinically relevant. (Need normal values for each.) |
| Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities | From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Vital sign abnormalities considered by the investigator as clinically relevant. |
| Extension Phase: Adverse Events (AEs), by Maximum Intensity | From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death). |
| Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities | From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | Chemistry, hematology, and urinalysis abnormalities considered by the investigator as clinically relevant. Hematocrit: ≤37%(M)/≤32%(F)+3 percentage pts↓from baseline. |
| Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities | From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks]) | ECG abnormalities considered by the investigator as clinically relevant.Left Bundle Branch Block: Not present at Baseline--\> present post-baseline. |
| Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change) | The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 10 Score range from 0 to 4. A negative score signifies improvement. |
Countries
Brazil, Bulgaria, Croatia, Czechia, France, India, Russia, South Africa, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets | 169 |
| Aripiprazole Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets | 168 |
| Total | 337 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 1: Confirmation of Partial Nonresponse | Adverse Event | 33 | 0 | 0 |
| 1: Confirmation of Partial Nonresponse | Lost to Follow-up | 111 | 0 | 0 |
| 1: Confirmation of Partial Nonresponse | Other Reasons | 16 | 0 | 0 |
| 1: Confirmation of Partial Nonresponse | Poor/Noncompliance | 23 | 0 | 0 |
| 1: Confirmation of Partial Nonresponse | Pregnancy | 1 | 0 | 0 |
| 1: Confirmation of Partial Nonresponse | Subject No Longer Met Study Criteria | 307 | 0 | 0 |
| 1: Confirmation of Partial Nonresponse | Withdrawal by Subject | 93 | 0 | 0 |
| 2: Stability & Maintenance of Stability | Administrative Reason by Sponsor | 1 | 0 | 0 |
| 2: Stability & Maintenance of Stability | Adverse Event | 93 | 0 | 0 |
| 2: Stability & Maintenance of Stability | Lack of Efficacy | 43 | 0 | 0 |
| 2: Stability & Maintenance of Stability | Lost to Follow-up | 59 | 0 | 0 |
| 2: Stability & Maintenance of Stability | Other Reasons | 13 | 0 | 0 |
| 2: Stability & Maintenance of Stability | Poor/Noncompliance | 33 | 0 | 0 |
| 2: Stability & Maintenance of Stability | Pregnancy | 1 | 0 | 0 |
| 2: Stability & Maintenance of Stability | subject No Longer Met Study Criteria | 32 | 0 | 0 |
| 2: Stability & Maintenance of Stability | Withdrawal by Subject | 65 | 0 | 0 |
| 3: Assessment of Relapse | Administrative Reason By Sponsor | 0 | 0 | 2 |
| 3: Assessment of Relapse | Adverse Event | 0 | 15 | 19 |
| 3: Assessment of Relapse | Death | 0 | 0 | 1 |
| 3: Assessment of Relapse | Lack of Efficacy | 0 | 31 | 14 |
| 3: Assessment of Relapse | Lost to Follow-up | 0 | 7 | 6 |
| 3: Assessment of Relapse | Other Reasons | 0 | 4 | 3 |
| 3: Assessment of Relapse | Poor/Noncompliance | 0 | 5 | 3 |
| 3: Assessment of Relapse | Pregnancy | 0 | 2 | 1 |
| 3: Assessment of Relapse | Subject No Longer Meets Study Criteria | 0 | 2 | 1 |
| 3: Assessment of Relapse | Withdrawal by Subject | 0 | 14 | 15 |
| 4: Extension Phase | Adverse Event | 0 | 1 | 0 |
| 4: Extension Phase | Lost to Follow-up | 0 | 1 | 0 |
| 4: Extension Phase | Withdrawal by Subject | 0 | 1 | 2 |
Baseline characteristics
| Characteristic | Placebo | Total | Aripiprazole |
|---|---|---|---|
| Age, Continuous | 38.8 years STANDARD_DEVIATION 12.29 | 39.0 years STANDARD_DEVIATION 12.34 | 39.2 years STANDARD_DEVIATION 12.43 |
| Body Mass Index (BMI) | 28.7 kg/m^2 STANDARD_DEVIATION 7.72 | 28.6 kg/m^2 STANDARD_DEVIATION 6.9 | 28.5 kg/m^2 STANDARD_DEVIATION 6 |
| Body Mass Index (BMI) Category <18.5 kg/m^2 | 5 Participants | 5 Participants | 0 Participants |
| Body Mass Index (BMI) Category 18.5 kg/m^2 to <25 kg/m^2 | 58 Participants | 107 Participants | 49 Participants |
| Body Mass Index (BMI) Category 25 kg/m^2 to <30 kg/m^2 | 50 Participants | 113 Participants | 63 Participants |
| Body Mass Index (BMI) Category >= 30 kg/m^2 | 56 Participants | 112 Participants | 56 Participants |
| CGI-BP Change from Preceding Phase Score (Depression) | 3.0 units on a scale STANDARD_DEVIATION 1.34 | 3.0 units on a scale STANDARD_DEVIATION 1.32 | 3.0 units on a scale STANDARD_DEVIATION 1.31 |
| CGI-BP Change from Preceding Phase Score (Mania) | 1.6 units on a scale STANDARD_DEVIATION 0.81 | 1.5 units on a scale STANDARD_DEVIATION 0.72 | 1.4 units on a scale STANDARD_DEVIATION 0.63 |
| CGI-BP Change from Preceding Phase Score (Overall) | 1.6 units on a scale STANDARD_DEVIATION 0.85 | 1.6 units on a scale STANDARD_DEVIATION 0.77 | 1.5 units on a scale STANDARD_DEVIATION 0.69 |
| CGI-BP Severity of Illness Score (Depression) | 1.3 units on a scale STANDARD_DEVIATION 0.57 | 1.4 units on a scale STANDARD_DEVIATION 0.64 | 1.4 units on a scale STANDARD_DEVIATION 0.7 |
| CGI-BP Severity of Illness Score (Mania) | 1.5 units on a scale STANDARD_DEVIATION 0.72 | 1.5 units on a scale STANDARD_DEVIATION 0.72 | 1.5 units on a scale STANDARD_DEVIATION 0.72 |
| CGI-BP Severity of Illness Score (Overall) | 1.6 units on a scale STANDARD_DEVIATION 0.76 | 1.6 units on a scale STANDARD_DEVIATION 0.79 | 1.7 units on a scale STANDARD_DEVIATION 0.83 |
| Montgomery Åsberg Depression Rating Scale (MADRS) Total Score | 3.7 units on a scale STANDARD_DEVIATION 3.45 | 3.9 units on a scale STANDARD_DEVIATION 3.64 | 4.1 units on a scale STANDARD_DEVIATION 3.82 |
| Race/Ethnicity, Customized Asian | 33 participants | 67 participants | 34 participants |
| Race/Ethnicity, Customized Black/African American | 19 participants | 31 participants | 12 participants |
| Race/Ethnicity, Customized Hispanic/Latino | 3 Participants | 8 Participants | 5 Participants |
| Race/Ethnicity, Customized Non-US | 111 Participants | 218 Participants | 107 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 55 Participants | 111 Participants | 56 Participants |
| Race/Ethnicity, Customized Other | 5 participants | 9 participants | 4 participants |
| Race/Ethnicity, Customized White | 112 participants | 230 participants | 118 participants |
| Region of Enrollment Brazil | 28 participants | 55 participants | 27 participants |
| Region of Enrollment Croatia | 3 participants | 7 participants | 4 participants |
| Region of Enrollment Czech Republic | 18 participants | 32 participants | 14 participants |
| Region of Enrollment France | 8 participants | 17 participants | 9 participants |
| Region of Enrollment India | 33 participants | 67 participants | 34 participants |
| Region of Enrollment Russian Federation | 17 participants | 32 participants | 15 participants |
| Region of Enrollment South Africa | 4 participants | 8 participants | 4 participants |
| Region of Enrollment United States | 58 participants | 119 participants | 61 participants |
| Sex: Female, Male Female | 98 Participants | 185 Participants | 87 Participants |
| Sex: Female, Male Male | 71 Participants | 152 Participants | 81 Participants |
| Weight | 81.3 kg STANDARD_DEVIATION 25.11 | 81.0 kg STANDARD_DEVIATION 22.2 | 80.6 kg STANDARD_DEVIATION 18.89 |
| Young-Mania Rating Scale (Y-MRS) Total Score | 4.1 units on a scale STANDARD_DEVIATION 3.31 | 4.1 units on a scale STANDARD_DEVIATION 3.43 | 4.1 units on a scale STANDARD_DEVIATION 3.56 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 402 / 682 | 61 / 166 | 68 / 167 | 5 / 19 | 6 / 23 |
| serious Total, serious adverse events | 15 / 682 | 8 / 166 | 11 / 167 | 0 / 19 | 0 / 23 |
Outcome results
Primary
Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3
Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: hospitalization for a manic, mixed or depressive episode; serious adverse event of worsening disease under study accompanied by a Y-MRS \> 16 and/or a MADRS \> 16; discontinuation due to lack of efficacy as determined by the investigator accompanied by a Y-MRS \> 16 and/or a MADRS \> 16.
Time frame: Week 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Randomized Sample; n=number of participants at risk at each time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 0 (n=169, 168) | 1.00 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 4 (n=153, 148) | 0.95 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 8 (n=148, 139) | 0.93 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 12 (n=142, 133) | 0.90 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 16 (n=131, 130) | 0.87 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 20 (n=122, 128) | 0.83 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 24 (n=113, 125) | 0.81 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 28 (n=105, 121) | 0.77 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 32 (n=102, 114) | 0.76 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 36 (n=99, 111) | 0.75 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 40 (n=95, 110) | 0.73 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 44 (n=91,107) | 0.73 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 48 (n=88, 98) | 0.71 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 52 (n=5, 8) | 0.71 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 40 (n=95, 110) | 0.84 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 0 (n=169, 168) | 1.00 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 28 (n=105, 121) | 0.89 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 4 (n=153, 148) | 0.96 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 48 (n=88, 98) | 0.83 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 8 (n=148, 139) | 0.94 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 32 (n=102, 114) | 0.84 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 12 (n=142, 133) | 0.93 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 44 (n=91,107) | 0.84 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 16 (n=131, 130) | 0.92 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 36 (n=99, 111) | 0.84 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 20 (n=122, 128) | 0.91 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 52 (n=5, 8) | 0.83 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 | Proportion at Week 24 (n=113, 125) | 0.89 proportion of participants |
p-value: 0.01495% CI: [0.332, 0.893]Stratified Log-rank Test
Secondary
Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3
The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 10 Score range from 0 to 4. A negative score signifies improvement.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)
Population: Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Change at Week 4 (n=160, 162) | -0.00 units on a scale | Standard Error 0.01 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Change at Week 36 (n=97, 105) | 0.02 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Change at Week 12 (n=144, 136) | 0.02 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Change at Week 52 (n=85, 96) | 0.01 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Change at Week 8 (n=151, 145) | 0.02 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Change at Week 52 LOCF (n=164, 162) | 0.00 units on a scale | Standard Error 0.01 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Change at Week 24 (n=113, 120) | 0.05 units on a scale | Standard Error 0.03 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Highest Value in Change During Phase 3 (n=164,162) | 0.04 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Baseline (n=164, 162) | 0.02 units on a scale | Standard Error 0.01 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Highest Value in Change During Phase 3 (n=164,162) | 0.06 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Baseline (n=164, 162) | 0.04 units on a scale | Standard Error 0.01 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Change at Week 4 (n=160, 162) | 0.03 units on a scale | Standard Error 0.01 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Change at Week 8 (n=151, 145) | 0.01 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Change at Week 12 (n=144, 136) | 0.00 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Change at Week 24 (n=113, 120) | -0.01 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Change at Week 36 (n=97, 105) | -0.02 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Change at Week 52 (n=85, 96) | -0.03 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 | Change at Week 52 LOCF (n=164, 162) | -0.01 units on a scale | Standard Error 0.01 |
Comparison: Week 52 LOCF Treatment Differencep-value: 0.57695% CI: [-0.05, 0.03]ANOVA/ANCOVA
Comparison: Highest Value treatment Differencep-value: 0.63695% CI: [-0.05, 0.08]ANOVA/ANCOVA
Secondary
Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3
The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 8 Score range from 0 to 4. A negative score signifies improvement.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)
Population: Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Change at Week 8 (n=151, 145) | 0.01 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Change at Week 36 (n=97, 105) | 0.01 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Change at Week 4 (n=160, 162) | -0.01 units on a scale | Standard Error 0.01 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Change at Week 52 (n=85, 96) | -0.00 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Change at Week 12 (n=144, 136) | 0.02 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Change at Week 52 LOCF (n=164, 162) | 0.01 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Baseline (n=164, 162) | 0.04 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Highest Value in Change During Phase 3 (n=164,162) | 0.03 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Change at Week 24 (n=113, 120) | 0.02 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Highest Value in Change During Phase 3 (n=164,162) | 0.07 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Change at Week 4 (n=160, 162) | 0.03 units on a scale | Standard Error 0.01 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Change at Week 8 (n=151, 145) | 0.02 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Change at Week 12 (n=144, 136) | 0.01 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Change at Week 24 (n=113, 120) | 0.00 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Change at Week 36 (n=97, 105) | -0.00 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Change at Week 52 (n=85, 96) | -0.01 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Change at Week 52 LOCF (n=164, 162) | 0.01 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 | Baseline (n=164, 162) | 0.03 units on a scale | Standard Error 0.02 |
Comparison: Week 52 LOCF Treatment Differencep-value: 0.90495% CI: [-0.04, 0.04]ANOVA/ANCOVA
Comparison: Highest Value of Change Treatment Differencep-value: 0.22295% CI: [-0.03, 0.11]ANOVA/ANCOVA
Secondary
Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3
The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). AIMS Item 9 Score range from 0 to 4. A negative score signifies improvement.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)
Population: Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Change at Week 4 (n=160, 162) | -0.01 units on a scale | Standard Error 0.01 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Change at Week 36 (n=97, 105) | 0.03 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Change at Week 12 (n=144, 136) | 0.03 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Change at Week 52 (n=85, 96) | 0.02 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Change at Week 8 (n=151, 145) | 0.03 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Change at Week 52 LOCF (n=164, 162) | 0.01 units on a scale | Standard Error 0.01 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Change at Week 24 (n=113, 120) | 0.03 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Highest Value in Change During Phase 3 (n=164,162) | 0.04 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Baseline (n=164, 162) | 0.01 units on a scale | Standard Error 0.01 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Highest Value in Change During Phase 3 (n=164,162) | 0.05 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Baseline (n=164, 162) | 0.01 units on a scale | Standard Error 0.01 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Change at Week 4 (n=160, 162) | 0.01 units on a scale | Standard Error 0.01 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Change at Week 8 (n=151, 145) | 0.02 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Change at Week 12 (n=144, 136) | 0.01 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Change at Week 24 (n=113, 120) | 0.01 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Change at Week 36 (n=97, 105) | -0.00 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Change at Week 52 (n=85, 96) | -0.00 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 | Change at Week 52 LOCF (n=164, 162) | 0.01 units on a scale | Standard Error 0.01 |
Comparison: Week 52 LOCF Treatment Differencep-value: 0.80895% CI: [-0.03, 0.04]ANOVA/ANCOVA
Comparison: Highest Value of Change Treatment Differencep-value: 0.771ANOVA/ANCOVA
Secondary
Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3
The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)
Population: Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Change at Week 4 (n=160, 162) | -0.01 units on a scale | Standard Error 0.05 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Change at Week 36 (n=97, 105) | 0.08 units on a scale | Standard Error 0.08 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Change at Week 12 (n=144, 136) | 0.10 units on a scale | Standard Error 0.07 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Change at Week 52 (n=85, 96) | 0.06 units on a scale | Standard Error 0.08 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Change at Week 8 (n=151, 145) | 0.11 units on a scale | Standard Error 0.08 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Change at Week 52 LOCF (n=164, 162) | 0.01 units on a scale | Standard Error 0.06 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Change at Week 24 (n=113, 120) | 0.13 units on a scale | Standard Error 0.09 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Highest Value in Change During Phase 3 (n=164,162) | 0.16 units on a scale | Standard Error 0.1 |
| Placebo | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Baseline (n=164, 162) | 0.11 units on a scale | Standard Error 0.05 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Highest Value in Change During Phase 3 (n=164,162) | 0.28 units on a scale | Standard Error 0.1 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Baseline (n=164, 162) | 0.14 units on a scale | Standard Error 0.05 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Change at Week 4 (n=160, 162) | 0.05 units on a scale | Standard Error 0.04 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Change at Week 8 (n=151, 145) | 0.11 units on a scale | Standard Error 0.08 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Change at Week 12 (n=144, 136) | -0.01 units on a scale | Standard Error 0.07 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Change at Week 24 (n=113, 120) | -0.03 units on a scale | Standard Error 0.08 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Change at Week 36 (n=97, 105) | -0.07 units on a scale | Standard Error 0.08 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Change at Week 52 (n=85, 96) | -0.02 units on a scale | Standard Error 0.08 |
| Aripiprazole | Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 | Change at Week 52 LOCF (n=164, 162) | 0.06 units on a scale | Standard Error 0.06 |
Comparison: Week 52 LOCF Treatment Differencep-value: 0.51495% CI: [-0.12, 0.23]ANOVA/ANCOVA
Comparison: Highest Value of Change Treatment Differencep-value: 0.36295% CI: [-0.14, 0.38]ANOVA/ANCOVA
Secondary
Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3
The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.
Time frame: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)
Population: Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Change at Week 4 (n=160, 162) | -0.01 units on a scale | Standard Error 0.03 |
| Placebo | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Change at Week 36 (n=97, 104) | -0.09 units on a scale | Standard Error 0.03 |
| Placebo | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Change at Week 12 (n=144, 136) | -0.07 units on a scale | Standard Error 0.03 |
| Placebo | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Change at Week 52 (n=85, 96) | -0.10 units on a scale | Standard Error 0.03 |
| Placebo | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Change at Week 8 (n=151, 144) | -0.06 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Change at Week 52 LOCF (n=164, 162) | -0.06 units on a scale | Standard Error 0.02 |
| Placebo | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Change at Week 24 (n=113, 120) | -0.06 units on a scale | Standard Error 0.03 |
| Placebo | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Highest Value in Change During Phase 3 (n=164,162) | 0.07 units on a scale | Standard Error 0.04 |
| Placebo | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Baseline (n=164, 162) | 0.10 units on a scale | Standard Error 0.04 |
| Aripiprazole | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Highest Value in Change During Phase 3 (n=164,162) | 0.11 units on a scale | Standard Error 0.04 |
| Aripiprazole | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Baseline (n=164, 162) | 0.16 units on a scale | Standard Error 0.04 |
| Aripiprazole | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Change at Week 4 (n=160, 162) | 0.01 units on a scale | Standard Error 0.03 |
| Aripiprazole | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Change at Week 8 (n=151, 144) | -0.04 units on a scale | Standard Error 0.02 |
| Aripiprazole | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Change at Week 12 (n=144, 136) | -0.03 units on a scale | Standard Error 0.03 |
| Aripiprazole | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Change at Week 24 (n=113, 120) | -0.04 units on a scale | Standard Error 0.03 |
| Aripiprazole | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Change at Week 36 (n=97, 104) | -0.05 units on a scale | Standard Error 0.03 |
| Aripiprazole | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Change at Week 52 (n=85, 96) | -0.07 units on a scale | Standard Error 0.03 |
| Aripiprazole | Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 | Change at Week 52 LOCF (n=164, 162) | -0.05 units on a scale | Standard Error 0.02 |
Comparison: Week 52 LOCF Treatment Differencep-value: 0.77495% CI: [-0.06, 0.08]ANOVA/ANCOVA
Comparison: Highest Value of Change, Treatment Differencep-value: 0.44495% CI: [-0.06, 0.14]ANOVA/ANCOVA
Secondary
Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3
The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower scores=less severe). Negative change scores indicate improvement.
Time frame: Baseline, Weeks 4,8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)
Population: Phase 3 Safety Sample, OC Data Set and Week 52 LOCF; n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Change at Week 4 (n=160, 161) | -0.02 units on a scale | Standard Error 0.07 |
| Placebo | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Change at Week 36 (n=97, 104) | -0.26 units on a scale | Standard Error 0.09 |
| Placebo | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Change at Week 12 (n=144, 136) | -0.20 units on a scale | Standard Error 0.05 |
| Placebo | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Change at Week 52 (n=85, 95) | -0.24 units on a scale | Standard Error 0.08 |
| Placebo | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Change at Week 8 (n=151, 145) | -0.13 units on a scale | Standard Error 0.06 |
| Placebo | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Change at Week 52 LOCF (n=164, 162) | -0.20 units on a scale | Standard Error 0.06 |
| Placebo | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Change at Week 24 (n=113, 120) | -0.24 units on a scale | Standard Error 0.07 |
| Placebo | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Highest Value in Change During Phase 3 (n=164,162) | 0.17 units on a scale | Standard Error 0.1 |
| Placebo | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Baseline (n=164, 162) | 10.48 units on a scale | Standard Error 0.09 |
| Aripiprazole | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Highest Value in Change During Phase 3 (n=164,162) | 0.53 units on a scale | Standard Error 0.1 |
| Aripiprazole | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Baseline (n=164, 162) | 10.50 units on a scale | Standard Error 0.09 |
| Aripiprazole | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Change at Week 4 (n=160, 161) | 0.04 units on a scale | Standard Error 0.07 |
| Aripiprazole | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Change at Week 8 (n=151, 145) | -0.03 units on a scale | Standard Error 0.06 |
| Aripiprazole | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Change at Week 12 (n=144, 136) | -0.10 units on a scale | Standard Error 0.05 |
| Aripiprazole | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Change at Week 24 (n=113, 120) | -0.02 units on a scale | Standard Error 0.06 |
| Aripiprazole | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Change at Week 36 (n=97, 104) | 0.01 units on a scale | Standard Error 0.08 |
| Aripiprazole | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Change at Week 52 (n=85, 95) | -0.07 units on a scale | Standard Error 0.07 |
| Aripiprazole | Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 | Change at Week 52 LOCF (n=164, 162) | -0.10 units on a scale | Standard Error 0.06 |
Comparison: Week 52 LOCF Treatment Differencep-value: 0.23595% CI: [-0.07, 0.27]ANOVA/ANCOVA
Comparison: Highest Value in Change Treatment Differencep-value: 0.01295% CI: [0.08, 0.64]ANOVA/ANCOVA
Secondary
Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale \[1 to 7\], with 1 being very much improved and 7 being very much worse).
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 12 | 3.51 units on a scale | Standard Error 0.106 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 32 | 3.69 units on a scale | Standard Error 0.116 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 20 | 3.58 units on a scale | Standard Error 0.111 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 36 | 3.62 units on a scale | Standard Error 0.119 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 8 | 3.55 units on a scale | Standard Error 0.103 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 40 | 3.55 units on a scale | Standard Error 0.12 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 24 | 3.63 units on a scale | Standard Error 0.112 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 44 | 3.52 units on a scale | Standard Error 0.121 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 16 | 3.52 units on a scale | Standard Error 0.108 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 48 | 3.58 units on a scale | Standard Error 0.121 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 28 | 3.65 units on a scale | Standard Error 0.116 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 52 | 3.56 units on a scale | Standard Error 0.122 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 4 (n=160, 162) | 3.46 units on a scale | Standard Error 0.102 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 52 | 3.44 units on a scale | Standard Error 0.12 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 4 (n=160, 162) | 3.56 units on a scale | Standard Error 0.1 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 8 | 3.52 units on a scale | Standard Error 0.101 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 12 | 3.45 units on a scale | Standard Error 0.104 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 16 | 3.45 units on a scale | Standard Error 0.107 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 20 | 3.53 units on a scale | Standard Error 0.109 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 24 | 3.54 units on a scale | Standard Error 0.11 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 28 | 3.52 units on a scale | Standard Error 0.114 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 32 | 3.49 units on a scale | Standard Error 0.114 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 36 | 3.52 units on a scale | Standard Error 0.117 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 40 | 3.47 units on a scale | Standard Error 0.118 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 44 | 3.49 units on a scale | Standard Error 0.12 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 | Mean Change at Week 48 | 3.44 units on a scale | Standard Error 0.12 |
Comparison: Aripiprazole - Placebo; Week 4 Comparisonp-value: 0.48695% CI: [-0.17, 0.36]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 8 Comparisonp-value: 0.79395% CI: [-0.3, 0.23]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 12 Comparisonp-value: 0.66595% CI: [-0.34, 0.22]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 16 Comparisonp-value: 0.6595% CI: [-0.35, 0.22]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 20 Comparisonp-value: 0.70595% CI: [-0.34, 0.23]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 24 Comparisonp-value: 0.57295% CI: [-0.38, 0.21]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 28 Comparisonp-value: 0.41895% CI: [-0.43, 0.18]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 32 Comparisonp-value: 0.18595% CI: [-0.51, 0.1]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 36 Comparisonp-value: 0.53695% CI: [-0.41, 0.21]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 40 Comparisonp-value: 0.63795% CI: [-0.39, 0.24]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 44 Comparisonp-value: 0.87595% CI: [-0.34, 0.29]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 48 Comparisonp-value: 0.37895% CI: [-0.46, 0.17]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 52 Comparisonp-value: 0.47495% CI: [-0.43, 0.2]ANOVA/ANCOVA
Secondary
Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 12 | 3.14 units on a scale | Standard Error 0.118 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 32 | 3.31 units on a scale | Standard Error 0.124 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 20 | 3.29 units on a scale | Standard Error 0.12 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 36 | 3.37 units on a scale | Standard Error 0.125 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 8 | 3.17 units on a scale | Standard Error 0.113 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 40 | 3.32 units on a scale | Standard Error 0.126 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 24 | 3.26 units on a scale | Standard Error 0.125 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 44 | 3.33 units on a scale | Standard Error 0.128 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 16 | 3.27 units on a scale | Standard Error 0.118 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 48 | 3.35 units on a scale | Standard Error 0.13 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 28 | 3.37 units on a scale | Standard Error 0.126 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 52 | 3.29 units on a scale | Standard Error 0.131 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 4 (n=160, 162) | 2.96 units on a scale | Standard Error 0.111 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 52 | 2.89 units on a scale | Standard Error 0.129 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 4 (n=160, 162) | 3.00 units on a scale | Standard Error 0.108 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 8 | 2.98 units on a scale | Standard Error 0.111 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 12 | 3.03 units on a scale | Standard Error 0.116 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 16 | 2.98 units on a scale | Standard Error 0.115 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 20 | 3.03 units on a scale | Standard Error 0.118 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 24 | 2.96 units on a scale | Standard Error 0.123 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 28 | 3.01 units on a scale | Standard Error 0.124 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 32 | 3.00 units on a scale | Standard Error 0.122 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 36 | 2.94 units on a scale | Standard Error 0.123 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 40 | 2.94 units on a scale | Standard Error 0.124 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 44 | 2.96 units on a scale | Standard Error 0.125 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 | Mean Change at Week 48 | 2.96 units on a scale | Standard Error 0.128 |
Comparison: Aripiprazole - Placebo; Week 4 Comparisonp-value: 0.77495% CI: [-0.25, 0.33]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 8 Comparisonp-value: 0.21395% CI: [-0.49, 0.11]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 12 Comparisonp-value: 0.46595% CI: [-0.43, 0.2]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 16 Comparisonp-value: 0.06895% CI: [-0.59, 0.02]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 20 Comparisonp-value: 0.09595% CI: [-0.58, 0.05]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 24 Comparisonp-value: 0.08295% CI: [-0.62, 0.04]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 28 Comparisonp-value: 0.03395% CI: [-0.69, -0.03]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 32 Comparisonp-value: 0.06295% CI: [-0.64, 0.02]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 36 Comparisonp-value: 0.01195% CI: [-0.76, -0.1]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 40 Comparisonp-value: 0.02795% CI: [-0.7, -0.04]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 44 Comparisonp-value: 0.02995% CI: [-0.71, -0.04]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 48 Comparisonp-value: 0.02295% CI: [-0.74, -0.06]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 52 Comparisonp-value: 0.02395% CI: [-0.75, -0.06]ANOVA/ANCOVA
Secondary
Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale \[1 to 7\], with 1 being very much improved and 7 being very much worse).
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 12 | 3.34 units on a scale | Standard Error 0.122 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 32 | 3.63 units on a scale | Standard Error 0.13 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 20 | 3.53 units on a scale | Standard Error 0.125 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 36 | 3.61 units on a scale | Standard Error 0.132 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 8 | 3.36 units on a scale | Standard Error 0.118 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 40 | 3.54 units on a scale | Standard Error 0.133 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 24 | 3.60 units on a scale | Standard Error 0.127 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 44 | 3.57 units on a scale | Standard Error 0.135 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 16 | 3.45 units on a scale | Standard Error 0.121 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 48 | 3.63 units on a scale | Standard Error 0.136 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 28 | 3.65 units on a scale | Standard Error 0.13 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 52 | 3.58 units on a scale | Standard Error 0.138 |
| Placebo | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 4 (n=160, 162) | 3.17 units on a scale | Standard Error 0.113 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 52 | 3.25 units on a scale | Standard Error 0.135 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 4 (n=160, 162) | 3.27 units on a scale | Standard Error 0.11 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 8 | 3.22 units on a scale | Standard Error 0.116 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 12 | 3.27 units on a scale | Standard Error 0.12 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 16 | 3.22 units on a scale | Standard Error 0.119 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 20 | 3.31 units on a scale | Standard Error 0.122 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 24 | 3.31 units on a scale | Standard Error 0.125 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 28 | 3.31 units on a scale | Standard Error 0.127 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 32 | 3.29 units on a scale | Standard Error 0.128 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 36 | 3.28 units on a scale | Standard Error 0.13 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 40 | 3.24 units on a scale | Standard Error 0.131 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 44 | 3.28 units on a scale | Standard Error 0.132 |
| Aripiprazole | Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 | Mean Change at Week 48 | 3.26 units on a scale | Standard Error 0.134 |
Comparison: Aripiprazole - Placebo; Week 4 Comparisonp-value: 0.48895% CI: [-0.19, 0.4]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 8 Comparisonp-value: 0.34995% CI: [-0.46, 0.16]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 12 Comparisonp-value: 0.65395% CI: [-0.39, 0.25]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 16 Comparisonp-value: 0.14195% CI: [-0.56, 0.08]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 20 Comparisonp-value: 0.19695% CI: [-0.54, 0.11]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 24 Comparisonp-value: 0.08895% CI: [-0.62, 0.04]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 28 Comparisonp-value: 0.04795% CI: [-0.68, -0.01]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 32 Comparisonp-value: 0.05795% CI: [-0.67, 0.01]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 36 Comparisonp-value: 0.06395% CI: [-0.68, 0.02]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 40 Comparisonp-value: 0.09195% CI: [-0.65, 0.05]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 44 Comparisonp-value: 0.10595% CI: [-0.64, 0.06]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 48 Comparisonp-value: 0.04795% CI: [-0.72, -0.01]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 52 Comparisonp-value: 0.07395% CI: [-0.69, 0.03]ANOVA/ANCOVA
Secondary
Baseline Abnormal Involuntary Movement Scale (AIMS)
The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.
Time frame: Baseline
Population: Phase 2 Safety Sample, participants with evaluation at time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline Abnormal Involuntary Movement Scale (AIMS) | 0.10 units on a scale | Standard Error 0.042 |
| Aripiprazole | Baseline Abnormal Involuntary Movement Scale (AIMS) | 0.08 units on a scale | Standard Error 0.028 |
Secondary
Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.
Time frame: Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Baseline Mean | 1.43 units on a scale | Standard Error 0.049 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 4 (n=160, 162) | 0.30 units on a scale | Standard Error 0.067 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 8 | 0.35 units on a scale | Standard Error 0.073 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 12 | 0.37 units on a scale | Standard Error 0.077 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 16 | 0.35 units on a scale | Standard Error 0.078 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 20 | 0.41 units on a scale | Standard Error 0.084 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 24 | 0.44 units on a scale | Standard Error 0.086 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 28 | 0.50 units on a scale | Standard Error 0.091 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 32 | 0.53 units on a scale | Standard Error 0.092 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 36 | 0.49 units on a scale | Standard Error 0.092 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 40 | 0.47 units on a scale | Standard Error 0.093 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 44 | 0.46 units on a scale | Standard Error 0.094 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 48 | 0.50 units on a scale | Standard Error 0.094 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 52 | 0.51 units on a scale | Standard Error 0.094 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 40 | 0.28 units on a scale | Standard Error 0.091 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Baseline Mean | 1.47 units on a scale | Standard Error 0.048 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 28 | 0.28 units on a scale | Standard Error 0.09 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 4 (n=160, 162) | 0.29 units on a scale | Standard Error 0.065 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 48 | 0.27 units on a scale | Standard Error 0.092 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 8 | 0.24 units on a scale | Standard Error 0.072 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 32 | 0.27 units on a scale | Standard Error 0.091 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 12 | 0.23 units on a scale | Standard Error 0.076 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 44 | 0.28 units on a scale | Standard Error 0.093 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 16 | 0.24 units on a scale | Standard Error 0.077 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 36 | 0.32 units on a scale | Standard Error 0.091 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 20 | 0.28 units on a scale | Standard Error 0.083 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 52 | 0.30 units on a scale | Standard Error 0.093 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 | Mean Change from Baseline at Week 24 | 0.27 units on a scale | Standard Error 0.085 |
Comparison: Aripiprazole - Placebo; Baseline Comparisonp-value: 0.58895% CI: [-0.09, 0.16]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 4 Comparisonp-value: 0.92295% CI: [-0.18, 0.16]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 8 Comparisonp-value: 0.26695% CI: [-0.3, 0.08]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 12 Comparisonp-value: 0.15995% CI: [-0.34, 0.06]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 16 Comparisonp-value: 0.30595% CI: [-0.31, 0.1]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 20 Comparisonp-value: 0.25195% CI: [-0.35, 0.09]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 24 Comparisonp-value: 0.13595% CI: [-0.4, 0.05]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 28 Comparisonp-value: 0.07395% CI: [-0.46, 0.02]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 32 Comparisonp-value: 0.03495% CI: [-0.5, -0.02]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 36 Comparisonp-value: 0.17495% CI: [-0.41, 0.07]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 40 Comparisonp-value: 0.13295% CI: [-0.43, 0.06]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 44 Comparisonp-value: 0.15295% CI: [-0.42, 0.07]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 48 Comparisonp-value: 0.0695% CI: [-0.48, 0.01]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 52 Comparisonp-value: 0.08595% CI: [-0.46, 0.03]ANOVA/ANCOVA
Secondary
Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.
Time frame: Baseline (end of Phase 2), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
Population: LOCF data set, phase 3 efficacy sample; n=number of participants evaluated at given time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Baseline (n=164, 162) | 1.54 units on a scale | Standard Error 0.059 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 4 (n=160, 162) | 0.01 units on a scale | Standard Error 0.052 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 8 (n=164, 162) | 0.05 units on a scale | Standard Error 0.054 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 12 (n=164, 162) | 0.12 units on a scale | Standard Error 0.063 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 16 (n=164, 162) | 0.19 units on a scale | Standard Error 0.064 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 20 (n=164, 162) | 0.23 units on a scale | Standard Error 0.071 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 24 (n=164, 162) | 0.25 units on a scale | Standard Error 0.074 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 28 (n=164, 162) | 0.31 units on a scale | Standard Error 0.082 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 32 (n=164, 162) | 0.27 units on a scale | Standard Error 0.078 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 36 (n=164, 162) | 0.30 units on a scale | Standard Error 0.079 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 40 (n=164, 162) | 0.27 units on a scale | Standard Error 0.08 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 44 (n=164, 162) | 0.33 units on a scale | Standard Error 0.082 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 48 (n=164, 162) | 0.33 units on a scale | Standard Error 0.082 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 52 (n=164, 162) | 0.32 units on a scale | Standard Error 0.083 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 40 (n=164, 162) | 0.05 units on a scale | Standard Error 0.079 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Baseline (n=164, 162) | 1.54 units on a scale | Standard Error 0.058 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 28 (n=164, 162) | 0.10 units on a scale | Standard Error 0.08 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 4 (n=160, 162) | 0.05 units on a scale | Standard Error 0.05 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 48 (n=164, 162) | 0.05 units on a scale | Standard Error 0.081 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 8 (n=164, 162) | 0.01 units on a scale | Standard Error 0.053 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 32 (n=164, 162) | 0.08 units on a scale | Standard Error 0.076 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 12 (n=164, 162) | 0.07 units on a scale | Standard Error 0.062 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 44 (n=164, 162) | 0.06 units on a scale | Standard Error 0.08 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 16 (n=164, 162) | 0.07 units on a scale | Standard Error 0.063 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 36 (n=164, 162) | 0.05 units on a scale | Standard Error 0.078 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 20 (n=164, 162) | 0.07 units on a scale | Standard Error 0.07 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 52 (n=164, 162) | 0.04 units on a scale | Standard Error 0.082 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Clinical Global Impression Scale for Bipolar Disorder (CGI-BP) Severity of Illness Score (Mania) Through Phase 3 | Mean Change from Baseline to Week 24 (n=164, 162) | 0.05 units on a scale | Standard Error 0.073 |
Comparison: Aripiprazole - Placebo; Baseline Comparisonp-value: 0.91195% CI: [-0.16, 0.15]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 4 Comparisonp-value: 0.55795% CI: [-0.09, 0.18]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 8 Comparisonp-value: 0.59695% CI: [-0.18, 0.1]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 12 Comparisonp-value: 0.52295% CI: [-0.22, 0.11]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 16 Comparisonp-value: 0.14295% CI: [-0.3, 0.04]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 20 Comparisonp-value: 0.09295% CI: [-0.35, 0.03]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 24 Comparisonp-value: 0.03995% CI: [-0.4, -0.01]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 28 Comparisonp-value: 0.0595% CI: [-0.43, 0]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 32 Comparisonp-value: 0.06495% CI: [-0.4, 0.01]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 36 Comparisonp-value: 0.01795% CI: [-0.46, -0.05]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 40 Comparisonp-value: 0.03995% CI: [-0.43, -0.01]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 44 Comparisonp-value: 0.01595% CI: [-0.48, -0.05]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 48 Comparisonp-value: 0.00995% CI: [-0.5, -0.07]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 52 Comparisonp-value: 0.01395% CI: [-0.5, -0.06]ANOVA/ANCOVA
Secondary
Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.
Time frame: Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: LOCF data set, phase 3 efficacy sample; 4 participants in the Week 4 placebo group were not evaluated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Baseline | 1.65 units on a scale | Standard Error 0.065 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 4 (n=160, 162) | 0.25 units on a scale | Standard Error 0.072 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 8 | 0.32 units on a scale | Standard Error 0.08 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 12 | 0.40 units on a scale | Standard Error 0.087 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 16 | 0.44 units on a scale | Standard Error 0.088 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 20 | 0.51 units on a scale | Standard Error 0.095 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 24 | 0.56 units on a scale | Standard Error 0.097 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 28 | 0.62 units on a scale | Standard Error 0.101 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 32 | 0.61 units on a scale | Standard Error 0.102 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 36 | 0.62 units on a scale | Standard Error 0.103 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 40 | 0.57 units on a scale | Standard Error 0.104 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 44 | 0.64 units on a scale | Standard Error 0.105 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 48 | 0.68 units on a scale | Standard Error 0.106 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 52 | 0.66 units on a scale | Standard Error 0.106 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 40 | 0.28 units on a scale | Standard Error 0.102 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Baseline | 1.70 units on a scale | Standard Error 0.064 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 28 | 0.32 units on a scale | Standard Error 0.099 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 4 (n=160, 162) | 0.27 units on a scale | Standard Error 0.07 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 48 | 0.28 units on a scale | Standard Error 0.104 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 8 | 0.21 units on a scale | Standard Error 0.079 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 32 | 0.30 units on a scale | Standard Error 0.1 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 12 | 0.26 units on a scale | Standard Error 0.085 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 44 | 0.30 units on a scale | Standard Error 0.103 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 16 | 0.26 units on a scale | Standard Error 0.087 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 36 | 0.33 units on a scale | Standard Error 0.101 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 20 | 0.29 units on a scale | Standard Error 0.094 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 52 | 0.31 units on a scale | Standard Error 0.104 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 | Mean Change from Baseline At Week 24 | 0.25 units on a scale | Standard Error 0.095 |
Comparison: Aripiprazole - Placebo; Baseline Comparisonp-value: 0.59795% CI: [-0.13, 0.22]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 4 Comparisonp-value: 0.83895% CI: [-0.17, 0.21]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 8 Comparisonp-value: 0.29195% CI: [-0.32, 0.1]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 12 Comparisonp-value: 0.21995% CI: [-0.37, 0.08]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 16 Comparisonp-value: 0.13395% CI: [-0.41, 0.05]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 20 Comparisonp-value: 0.09295% CI: [-0.46, 0.04]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 24 Comparisonp-value: 0.01895% CI: [-0.56, -0.05]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 28 Comparisonp-value: 0.02995% CI: [-0.56, -0.03]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 32 Comparisonp-value: 0.02495% CI: [-0.57, -0.04]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 36 Comparisonp-value: 0.03595% CI: [-0.56, -0.02]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 40 Comparisonp-value: 0.03895% CI: [-0.56, -0.02]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 44 Comparisonp-value: 0.01595% CI: [-0.62, -0.07]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 48 Comparisonp-value: 0.00695% CI: [-0.67, -0.12]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 52 Comparisonp-value: 0.01595% CI: [-0.62, -0.07]ANOVA/ANCOVA
Secondary
Baseline and Adjusted Mean Change From Baseline in Weight
Time frame: Baseline, Weeks 12, 24, 36, 52, During Phase 3 (for highest value)
Population: Observed Cases Data Set, Week 52 LOCF; n= number of participants with value at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Baseline and Adjusted Mean Change From Baseline in Weight | Change at Week 36 (n=89, 98) | 0.64 kg | Standard Error 0.65 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Weight | Baseline (n=161, 160) | 81.33 kg | Standard Error 1.8 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Weight | Change at Week 52 (n=85, 95) | 1.66 kg | Standard Error 0.78 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Weight | Change at Week 24 (n=111, 118) | 0.35 kg | Standard Error 0.53 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Weight | Change at Week 52 (LOCF) (n=161, 160) | 0.60 kg | Standard Error 0.49 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Weight | Highest Change Value (n=161, 160) | 2.39 kg | Standard Error 0.42 |
| Placebo | Baseline and Adjusted Mean Change From Baseline in Weight | Change at Week 12 (n=129, 121) | -1.00 kg | Standard Error 0.67 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Weight | Highest Change Value (n=161, 160) | 2.35 kg | Standard Error 0.42 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Weight | Baseline (n=161, 160) | 80.22 kg | Standard Error 1.79 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Weight | Change at Week 12 (n=129, 121) | 0.28 kg | Standard Error 0.69 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Weight | Change at Week 24 (n=111, 118) | 0.13 kg | Standard Error 0.51 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Weight | Change at Week 36 (n=89, 98) | 0.59 kg | Standard Error 0.6 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Weight | Change at Week 52 (n=85, 95) | 1.61 kg | Standard Error 0.72 |
| Aripiprazole | Baseline and Adjusted Mean Change From Baseline in Weight | Change at Week 52 (LOCF) (n=161, 160) | 1.07 kg | Standard Error 0.49 |
Comparison: Week 52 (LOCF) Treatment Differencep-value: 0.49195% CI: [-0.87, 1.81]ANOVA/ANCOVA
Comparison: Highest Value Treatment Differencep-value: 0.94595% CI: [-1.21, 1.12]ANOVA/ANCOVA
Secondary
Baseline in Barnes Akathisia Global Clinical Assessment
The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.
Time frame: Baseline
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline in Barnes Akathisia Global Clinical Assessment | 0.09 units on a scale | Standard Error 0.022 |
| Aripiprazole | Baseline in Barnes Akathisia Global Clinical Assessment | 0.14 units on a scale | Standard Error 0.024 |
Secondary
Baseline in Simpson-Angus Scale (SAS) Total Score
The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50.(lower score=less severe). Negative change scores indicate improvement.
Time frame: Baseline
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Baseline in Simpson-Angus Scale (SAS) Total Score | 10.28 units on a scale | Standard Error 0.054 |
| Aripiprazole | Baseline in Simpson-Angus Scale (SAS) Total Score | 10.30 units on a scale | Standard Error 0.048 |
Secondary
Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2
Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time frame: During Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2 | Deaths | 0 Participants |
| Placebo | Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2 | SAEs | 5 Participants |
| Placebo | Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2 | Discontinuations due to AEs | 38 Participants |
| Placebo | Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2 | Any AE | 226 Participants |
| Placebo | Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2 | Treatment-related AEs in >=2% of Participants | 188 Participants |
| Placebo | Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2 | Any Extrapyramidal Syndrome-Related AE | 108 Participants |
| Aripiprazole | Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2 | Treatment-related AEs in >=2% of Participants | 233 Participants |
| Aripiprazole | Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2 | Deaths | 0 Participants |
| Aripiprazole | Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2 | Any AE | 287 Participants |
| Aripiprazole | Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2 | SAEs | 10 Participants |
| Aripiprazole | Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2 | Any Extrapyramidal Syndrome-Related AE | 113 Participants |
| Aripiprazole | Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2 | Discontinuations due to AEs | 50 Participants |
Secondary
Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3
Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time frame: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Phase 3 Safety Sample
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3 | Treatment-Emergent SAEs | 8 Participants |
| Placebo | Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3 | Treatment-Emergent AEs in >=2% of Participants | 49 Participants |
| Placebo | Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3 | Deaths | 1 Participants |
| Placebo | Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3 | Treatment-Emergent AEs Leading to Discontinuation | 15 Participants |
| Placebo | Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3 | Treatment-Emergent AEs | 105 Participants |
| Aripiprazole | Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3 | Treatment-Emergent AEs Leading to Discontinuation | 19 Participants |
| Aripiprazole | Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3 | Treatment-Emergent SAEs | 11 Participants |
| Aripiprazole | Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3 | Treatment-Emergent AEs | 105 Participants |
| Aripiprazole | Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3 | Treatment-Emergent AEs in >=2% of Participants | 62 Participants |
| Aripiprazole | Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3 | Deaths | 1 Participants |
Secondary
Extension Phase: Adverse Events (AEs), by Maximum Intensity
AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death).
Time frame: From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Participants in Extension Phase Safety Sample with AEs
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Extension Phase: Adverse Events (AEs), by Maximum Intensity | Mild / Grade 1 | 4 Participants |
| Placebo | Extension Phase: Adverse Events (AEs), by Maximum Intensity | Moderate / Grade 2 | 1 Participants |
| Placebo | Extension Phase: Adverse Events (AEs), by Maximum Intensity | Severe / Grade 3 | 0 Participants |
| Placebo | Extension Phase: Adverse Events (AEs), by Maximum Intensity | Very Severe / Grade 4 | 0 Participants |
| Aripiprazole | Extension Phase: Adverse Events (AEs), by Maximum Intensity | Very Severe / Grade 4 | 0 Participants |
| Aripiprazole | Extension Phase: Adverse Events (AEs), by Maximum Intensity | Mild / Grade 1 | 7 Participants |
| Aripiprazole | Extension Phase: Adverse Events (AEs), by Maximum Intensity | Severe / Grade 3 | 0 Participants |
| Aripiprazole | Extension Phase: Adverse Events (AEs), by Maximum Intensity | Moderate / Grade 2 | 2 Participants |
Secondary
Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations
Participants with Adverse Events (AEs), Deaths, Serious AEs (SAEs), and AEs leading to study discontinuation. AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. SAE is any untoward medical occurrence that at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a cancer, is a congenital anomaly/birth defect, results in the development of drug dependency or drug abuse, is an important medical event.
Time frame: From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Extension Phase Safety Sample
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations | SAEs | 0 Participants |
| Placebo | Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations | Discontinuations due to AEs | 1 Participants |
| Placebo | Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations | AEs | 5 Participants |
| Placebo | Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations | Treatment-related AEs | 2 Participants |
| Placebo | Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations | Deaths | 0 Participants |
| Aripiprazole | Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations | Treatment-related AEs | 1 Participants |
| Aripiprazole | Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations | Deaths | 0 Participants |
| Aripiprazole | Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations | SAEs | 0 Participants |
| Aripiprazole | Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations | AEs | 8 Participants |
| Aripiprazole | Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations | Discontinuations due to AEs | 0 Participants |
Secondary
Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania)
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.
Time frame: Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72 of LTE Phase. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Number of participants analyzed=extension phase participants, observed cases (OC) data set; n=number of participants evaluated at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Baseline (N=19, 23) | 1.26 units on a scale | Standard Error 0.104 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 8 (n=19, 23) | -0.26 units on a scale | Standard Error 0.104 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 16 (n=18, 23) | -0.28 units on a scale | Standard Error 0.109 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 24 (n=17, 20) | -0.29 units on a scale | Standard Error 0.114 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 32 (n=15, 15) | 0.00 units on a scale | Standard Error 0.309 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 40 (n=9, 12) | -0.11 units on a scale | Standard Error 0.111 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 48 (n=9, 9) | -0.11 units on a scale | Standard Error 0.111 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 56 (n=5, 9) | 0.00 units on a scale | Standard Error 0 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 64 (n=5, 4) | 0.00 units on a scale | Standard Error 0 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 72 (n=1, 2) | 0.00 units on a scale | Standard Error 0 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 56 (n=5, 9) | -0.22 units on a scale | Standard Error 0.147 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Baseline (N=19, 23) | 1.35 units on a scale | Standard Error 0.102 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 40 (n=9, 12) | -0.33 units on a scale | Standard Error 0.142 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 8 (n=19, 23) | -0.30 units on a scale | Standard Error 0.098 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 72 (n=1, 2) | -0.50 units on a scale | Standard Error 0.5 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 16 (n=18, 23) | -0.30 units on a scale | Standard Error 0.098 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 48 (n=9, 9) | -0.22 units on a scale | Standard Error 0.147 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 24 (n=17, 20) | -0.40 units on a scale | Standard Error 0.112 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 64 (n=5, 4) | 0.00 units on a scale | Standard Error 0 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) | Mean Change at Week 32 (n=15, 15) | -0.33 units on a scale | Standard Error 0.126 |
Secondary
Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.
Time frame: Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Number of participants analyzed=extension phase participants, observed cases (OC) data set; n=number of participants evaluated at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Baseline (N=19, 23) | 1.21 units on a scale | Standard Error 0.123 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 8 (n=19, 23) | -0.11 units on a scale | Standard Error 0.13 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 16 (n=18, 23) | -0.11 units on a scale | Standard Error 0.137 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 24 (n=17, 20) | -0.12 units on a scale | Standard Error 0.146 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 32 (n=15, 15) | -0.20 units on a scale | Standard Error 0.175 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 40 (n=9, 12) | -0.11 units on a scale | Standard Error 0.2 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 48 (n=9, 9) | -0.11 units on a scale | Standard Error 0.2 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 56 (n=5, 9) | -0.20 units on a scale | Standard Error 0.2 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 64 (n=5, 4) | -0.20 units on a scale | Standard Error 0.2 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 72 (n=1, 2) | 0.00 units on a scale | Standard Error 0 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 56 (n=5, 9) | 0.00 units on a scale | Standard Error 0 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Baseline (N=19, 23) | 1.00 units on a scale | Standard Error 0 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 40 (n=9, 12) | 0.00 units on a scale | Standard Error 0 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 8 (n=19, 23) | 0.00 units on a scale | Standard Error 0 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 72 (n=1, 2) | 0.00 units on a scale | Standard Error 0 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 16 (n=18, 23) | 0.00 units on a scale | Standard Error 0 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 48 (n=9, 9) | 0.00 units on a scale | Standard Error 0 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 24 (n=17, 20) | 0.00 units on a scale | Standard Error 0 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 64 (n=5, 4) | 0.00 units on a scale | Standard Error 0 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase | Mean Change at Week 32 (n=15, 15) | 0.00 units on a scale | Standard Error 0 |
Secondary
Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.
Time frame: Baseline, Weeks 8, 16, 24, 32, 40, 48, 56, 64, 72. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Number of participants analyzed=extension phase participants, observed cases (OC) data set; n=number of participants evaluated at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Baseline (N=19, 23) | 1.37 units on a scale | Standard Error 0.114 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 8 (n=19, 23) | -0.26 units on a scale | Standard Error 0.129 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 16 (n=18, 23) | -0.28 units on a scale | Standard Error 0.135 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 24 (n=17, 20) | -0.29 units on a scale | Standard Error 0.143 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 32 (n=15, 15) | -0.07 units on a scale | Standard Error 0.33 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 40 (n=9, 12) | -0.22 units on a scale | Standard Error 0.222 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 48 (n=9, 9) | -0.22 units on a scale | Standard Error 0.222 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 56 (n=5, 9) | -0.20 units on a scale | Standard Error 0.2 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 64 (n=5, 4) | -0.20 units on a scale | Standard Error 0.2 |
| Placebo | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 72 (n=1, 2) | 0.00 units on a scale | Standard Error 0 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 56 (n=5, 9) | -0.22 units on a scale | Standard Error 0.147 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Baseline (N=19, 23) | 1.35 units on a scale | Standard Error 0.102 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 40 (n=9, 12) | -0.33 units on a scale | Standard Error 0.142 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 8 (n=19, 23) | -0.30 units on a scale | Standard Error 0.098 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 72 (n=1, 2) | -0.50 units on a scale | Standard Error 0.5 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 16 (n=18, 23) | -0.30 units on a scale | Standard Error 0.098 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 48 (n=9, 9) | -0.22 units on a scale | Standard Error 0.147 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 24 (n=17, 20) | -0.40 units on a scale | Standard Error 0.112 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 64 (n=5, 4) | 0.00 units on a scale | Standard Error 0 |
| Aripiprazole | Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase | Mean Change at Week 32 (n=15, 15) | -0.33 units on a scale | Standard Error 0.126 |
Secondary
Extension Phase: Mean Change From Baseline in CGI-BP (Mania) Severity of Illness at Extension Phase Endpoint
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.
Time frame: Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: extension phase participants, last observation carried forward (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Extension Phase: Mean Change From Baseline in CGI-BP (Mania) Severity of Illness at Extension Phase Endpoint | -0.05 units on a scale | Standard Error 0.247 |
| Aripiprazole | Extension Phase: Mean Change From Baseline in CGI-BP (Mania) Severity of Illness at Extension Phase Endpoint | -0.35 units on a scale | Standard Error 0.102 |
Secondary
Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Depression) at Extension Phase Endpoint
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.
Time frame: Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: extension phase participants, last observation carried forward (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Depression) at Extension Phase Endpoint | -0.16 units on a scale | Standard Error 0.138 |
| Aripiprazole | Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Depression) at Extension Phase Endpoint | 0.00 units on a scale | Standard Error 0 |
Secondary
Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Overall) at Extension Phase Endpoint
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.
Time frame: Baseline, Extension Phase Endpoint. LTE Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: extension phase participants, last observation carried forward (LOCF)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Overall) at Extension Phase Endpoint | -0.11 units on a scale | Standard Error 0.264 |
| Aripiprazole | Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Overall) at Extension Phase Endpoint | -0.35 units on a scale | Standard Error 0.102 |
Secondary
Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities
ECG abnormalities considered by the investigator as clinically relevant.Left Bundle Branch Block: Not present at Baseline--\> present post-baseline.
Time frame: From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Participants in Extension Phase Safety Sample with ECG evaluation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities | QTcF > 450 msec | 1 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities | QTcF Change from Baseline > 30 msec | 4 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities | QTcB > 450 msec | 1 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities | QTcB Change from Baseline > 60 msec | 1 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities | QTcB Change from Baseline > 30 msec | 3 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities | QTcF Change from Baseline > 60 msec | 1 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities | Left Bundle Branch Block (see description) | 4 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities | QTcF Change from Baseline > 60 msec | 0 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities | Left Bundle Branch Block (see description) | 1 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities | QTcB > 450 msec | 3 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities | QTcF > 450 msec | 1 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities | QTcB Change from Baseline > 30 msec | 5 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities | QTcF Change from Baseline > 30 msec | 3 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities | QTcB Change from Baseline > 60 msec | 0 Participants |
Secondary
Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities
Chemistry, hematology, and urinalysis abnormalities considered by the investigator as clinically relevant. Hematocrit: ≤37%(M)/≤32%(F)+3 percentage pts↓from baseline.
Time frame: From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Participants in Extension Phase Safety Sample with laboratory evaluation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities | Hematocrit (see description) | 2 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities | Eosinophils relative (calculated) ≥10% | 2 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities | Hemoglobin ≤11.5 g/dL(M)/≤9.5 g/dL(F) | 2 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities | Urine Glucose (any glucose in the urine) | 0 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities | Creatine Kinase >= 3 x ULN | 1 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities | Urine Glucose (any glucose in the urine) | 2 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities | Creatine Kinase >= 3 x ULN | 0 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities | Hematocrit (see description) | 0 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities | Hemoglobin ≤11.5 g/dL(M)/≤9.5 g/dL(F) | 0 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities | Eosinophils relative (calculated) ≥10% | 2 Participants |
Secondary
Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase
Metabolic abnormalities considered by the investigator as clinically relevant. (Need normal values for each.)
Time frame: From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Number of Participants Analyzed=Participants in Extension Phase Safety Sample; n=number of participants with evaluation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | Glucose, non-fasting (n=3,1) | 0 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | Glucose, fasting (n=17, 22) | 2 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | HDL Cholesterol, combined (n=18, 22) | 12 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | HDL Cholesterol, fasting (n=17, 22) | 12 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | HDL Cholesterol, non-fasting (n=2, 1) | 0 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | Total Cholesterol, combined (n=18, 22) | 0 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | Total Cholesterol, fasting (n=17, 22) | 0 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | Total Cholesterol, non-fasting (n=2, 1) | 0 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | LDL Cholesterol, combined (n=18, 22) | 1 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | LDL Cholesterol, fasting (n=17, 22) | 1 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | LDL Cholesterol, non-fasting (n=2, 1) | 0 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | Triglycerides, combined (n=18, 22) | 4 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | Triglycerides, fasting (n=17, 22) | 4 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | Triglycerides, non-fasting (n=2, 1) | 0 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | LDL Cholesterol, non-fasting (n=2, 1) | 0 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | Glucose, non-fasting (n=3,1) | 0 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | Total Cholesterol, non-fasting (n=2, 1) | 0 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | Glucose, fasting (n=17, 22) | 3 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | Triglycerides, fasting (n=17, 22) | 0 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | HDL Cholesterol, combined (n=18, 22) | 11 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | LDL Cholesterol, combined (n=18, 22) | 3 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | HDL Cholesterol, fasting (n=17, 22) | 11 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | Triglycerides, combined (n=18, 22) | 0 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | HDL Cholesterol, non-fasting (n=2, 1) | 0 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | LDL Cholesterol, fasting (n=17, 22) | 3 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | Total Cholesterol, combined (n=18, 22) | 1 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | Triglycerides, non-fasting (n=2, 1) | 0 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase | Total Cholesterol, fasting (n=17, 22) | 1 Participants |
Secondary
Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities
Vital sign abnormalities considered by the investigator as clinically relevant.
Time frame: From first day until 30 days after the last dose of double-blind dosing in the Extension Phase (A 72-week Extension Phase [until study unblinding] following Phase 3 [52 weeks], Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Extension Phase Safety Sample
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities | Systolic Blood Pressure Increase | 0 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities | Systolic Blood Pressure Decrease | 0 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities | Diastolic Blood Pressure Increase | 0 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities | Diastolic Blood Pressure Decrease | 0 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities | Heart Rate Increase | 0 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities | Heart Rate Decrease | 0 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities | Weight Increase | 1 Participants |
| Placebo | Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities | Weight Decrease | 2 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities | Weight Decrease | 1 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities | Systolic Blood Pressure Increase | 0 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities | Heart Rate Increase | 0 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities | Systolic Blood Pressure Decrease | 0 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities | Weight Increase | 7 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities | Diastolic Blood Pressure Increase | 0 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities | Heart Rate Decrease | 0 Participants |
| Aripiprazole | Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities | Diastolic Blood Pressure Decrease | 0 Participants |
Secondary
Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.
Time frame: Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: LOCF data set, phase 3 efficacy sample; N=number of participants evaluated at time point; 4 participants in the Week 4 placebo group were not evaluated.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Baseline (n=164, 162) | 4.41 units on a scale | Standard Error 0.282 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 4 (n=160, 162) | 1.92 units on a scale | Standard Error 0.421 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 8 (n=164, 162) | 2.27 units on a scale | Standard Error 0.495 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 12 (n=164, 162) | 2.42 units on a scale | Standard Error 0.493 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 16 (n=164, 162) | 2.12 units on a scale | Standard Error 0.505 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 20 (n=164, 162) | 2.61 units on a scale | Standard Error 0.557 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 24 (n=164, 162) | 2.92 units on a scale | Standard Error 0.572 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 28 (n=164, 162) | 3.14 units on a scale | Standard Error 0.601 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 32 (n=164, 162) | 3.32 units on a scale | Standard Error 0.609 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 36 (n=164, 162) | 3.03 units on a scale | Standard Error 0.621 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 40 (n=164, 162) | 3.18 units on a scale | Standard Error 0.626 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 44 (n=164, 162) | 3.10 units on a scale | Standard Error 0.641 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 48 (n=164, 162) | 3.57 units on a scale | Standard Error 0.633 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 52 (n=164, 162) | 3.47 units on a scale | Standard Error 0.64 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 40 (n=164, 162) | 1.65 units on a scale | Standard Error 0.618 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Baseline (n=164, 162) | 4.62 units on a scale | Standard Error 0.277 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 28 (n=164, 162) | 1.64 units on a scale | Standard Error 0.594 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 4 (n=160, 162) | 1.42 units on a scale | Standard Error 0.411 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 48 (n=164, 162) | 1.48 units on a scale | Standard Error 0.624 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 8 (n=164, 162) | 1.23 units on a scale | Standard Error 0.488 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 32 (n=164, 162) | 1.70 units on a scale | Standard Error 0.601 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 12 (n=164, 162) | 1.42 units on a scale | Standard Error 0.486 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 44 (n=164, 162) | 1.53 units on a scale | Standard Error 0.632 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 16 (n=164, 162) | 1.27 units on a scale | Standard Error 0.498 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 36 (n=164, 162) | 1.89 units on a scale | Standard Error 0.612 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 20 (n=164, 162) | 1.47 units on a scale | Standard Error 0.549 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 52 (n=164, 162) | 1.46 units on a scale | Standard Error 0.632 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 | Mean Change from Baseline at Week 24 (n=164, 162) | 1.49 units on a scale | Standard Error 0.564 |
Comparison: Aripiprazole - Placebo; Week 28 Comparisonp-value: 0.0695% CI: [-3.07, 0.06]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Baseline Comparisonp-value: 0.5995% CI: [-0.54, 0.94]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 4 Comparisonp-value: 0.37195% CI: [-1.59, 0.6]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 8 Comparisonp-value: 0.11395% CI: [-2.33, 0.25]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 12 Comparisonp-value: 0.12895% CI: [-2.28, 0.29]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 16 Comparisonp-value: 0.20595% CI: [-2.16, 0.47]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 20 Comparisonp-value: 0.12595% CI: [-2.59, 0.32]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 24 Comparisonp-value: 0.06195% CI: [-2.92, 0.06]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 32 Comparisonp-value: 0.04695% CI: [-3.21, -0.03]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 36 Comparisonp-value: 0.16495% CI: [-2.77, 0.47]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 40 Comparisonp-value: 0.06695% CI: [-3.16, 0.1]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 44 Comparisonp-value: 0.06695% CI: [-3.24, 0.1]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 48 Comparisonp-value: 0.01495% CI: [-3.73, -0.43]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 52 Comparisonp-value: 0.01995% CI: [-3.68, -0.34]ANOVA/ANCOVA
Secondary
Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3
The Y-MRS consists of 11 items: 1) Elevated Mood, 2) Increased Motor Activity -Energy, 3) Sexual Interest, 4) Sleep, 5) Irritability, 6) Speech (Rate and Amount), 7) Language -Thought Disorder, 8) Content, 9) Disruptive-Aggressive Behavior, 10) Appearance, 11) Insight. 7 items are rated on a 0 to 4 scale, while 4 items (items 5, 6, 8 and 9) are rated on a 0 to 8 scale (twice the weight of the other items.) For all items, 0 is the best rating and 4 or 8 is the worst rating. Total Score is the sum of the ratings for all 11 items. The possible Total Scores are from 0 (best) to 60 (worst).
Time frame: Baseline (end of Ph 2), Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: LOCF data set, phase 3 efficacy sample; n=number of participants with measurement at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 12 (n=164, 162) | 1.53 units on a scale | Standard Error 0.415 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Baseline (n=164, 162) | 4.03 units on a scale | Standard Error 0.285 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 4 (n=160, 162) | 0.47 units on a scale | Standard Error 0.342 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 8 (n=164, 162) | 0.91 units on a scale | Standard Error 0.353 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 16 (n=164, 162) | 1.74 units on a scale | Standard Error 0.433 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 20 (n=164, 162) | 2.29 units on a scale | Standard Error 0.472 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 24 (n=164, 162) | 2.42 units on a scale | Standard Error 0.492 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 28 (n=164, 162) | 3.02 units on a scale | Standard Error 0.547 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 32 (n=164, 162) | 2.72 units on a scale | Standard Error 0.526 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 36 (n=164, 162) | 3.04 units on a scale | Standard Error 0.538 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 40 (n=164, 162) | 2.82 units on a scale | Standard Error 0.542 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 44 (n=164, 162) | 3.19 units on a scale | Standard Error 0.558 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 48 (n=164, 162) | 3.15 units on a scale | Standard Error 0.575 |
| Placebo | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 52 (n=164, 162) | 2.93 units on a scale | Standard Error 0.576 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 40 (n=164, 162) | 0.11 units on a scale | Standard Error 0.532 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 28 (n=164, 162) | 0.40 units on a scale | Standard Error 0.537 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Baseline (n=164, 162) | 4.06 units on a scale | Standard Error 0.28 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 48 (n=164, 162) | 0.07 units on a scale | Standard Error 0.564 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 4 (n=160, 162) | 0.53 units on a scale | Standard Error 0.332 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 32 (n=164, 162) | 0.39 units on a scale | Standard Error 0.516 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 8 (n=164, 162) | 0.23 units on a scale | Standard Error 0.346 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 12 (n=164, 162) | 0.43 units on a scale | Standard Error 0.408 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 44 (n=164, 162) | 0.27 units on a scale | Standard Error 0.548 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 16 (n=164, 162) | 0.35 units on a scale | Standard Error 0.425 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 36 (n=164, 162) | 0.26 units on a scale | Standard Error 0.528 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 20 (n=164, 162) | 0.38 units on a scale | Standard Error 0.463 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 52 (n=164, 162) | -0.11 units on a scale | Standard Error 0.565 |
| Aripiprazole | Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 | Change at Week 24 (n=164, 162) | 0.24 units on a scale | Standard Error 0.483 |
Comparison: Aripiprazole - Placebo; Baseline Comparisonp-value: 0.95595% CI: [-0.73, 0.77]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 4 Comparisonp-value: 0.89595% CI: [-0.83, 0.95]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 8 Comparisonp-value: 0.14495% CI: [-1.61, 0.24]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 12 Comparisonp-value: 0.04795% CI: [-2.19, -0.01]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 16 Comparisonp-value: 0.01795% CI: [-2.52, -0.25]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 20 Comparisonp-value: 0.00395% CI: [-3.15, -0.68]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 24 Comparisonp-value: <0.00195% CI: [-3.47, -0.89]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 28 Comparisonp-value: <0.00195% CI: [-4.06, -1.19]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 32 Comparisonp-value: <0.00195% CI: [-3.7, -0.95]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 36 Comparisonp-value: <0.00195% CI: [-4.19, -1.37]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 40 Comparisonp-value: <0.00195% CI: [-4.13, -1.29]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 44 Comparisonp-value: <0.00195% CI: [-4.38, -1.46]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 48 Comparisonp-value: <0.00195% CI: [-4.59, -1.57]ANOVA/ANCOVA
Comparison: Aripiprazole - Placebo; Week 52 Comparisonp-value: <0.00195% CI: [-4.55, -1.54]ANOVA/ANCOVA
Secondary
Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders. MADRS total score, a 10-item, ordinal rating scale (0=no symptoms; 60=most severe symptoms). Change from baseline=postbaseline score - baseline score. A negative change score indicates improvement.
Time frame: Baseline (end of Ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 (Ph2) Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 4 (n=245, 326) | -2.94 units on a scale | Standard Error 0.391 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 12 (n=179, 253) | -2.82 units on a scale | Standard Error 0.5 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 2 (n=267, 355) | -2.23 units on a scale | Standard Error 0.352 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 16 (n=138, 193) | -2.88 units on a scale | Standard Error 0.698 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 6 (n=221, 305) | -2.92 units on a scale | Standard Error 0.466 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 20 (n=59, 99) | -4.68 units on a scale | Standard Error 0.944 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 1 (n=277, 371) | -1.48 units on a scale | Standard Error 0.295 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 24 (n=22, 39) | -3.77 units on a scale | Standard Error 1.298 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 8 (n=201, 287) | -3.07 units on a scale | Standard Error 0.46 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Ph2 Endpoint (n=289, 383) | -2.13 units on a scale | Standard Error 0.461 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Mean Baseline (n=289, 383) | 10.97 units on a scale | Standard Error 0.508 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Ph2 Endpoint (n=289, 383) | -2.54 units on a scale | Standard Error 0.412 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Mean Baseline (n=289, 383) | 11.56 units on a scale | Standard Error 0.432 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 1 (n=277, 371) | -1.51 units on a scale | Standard Error 0.256 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 2 (n=267, 355) | -2.70 units on a scale | Standard Error 0.329 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 4 (n=245, 326) | -3.16 units on a scale | Standard Error 0.357 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 6 (n=221, 305) | -3.69 units on a scale | Standard Error 0.383 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 8 (n=201, 287) | -3.64 units on a scale | Standard Error 0.44 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 12 (n=179, 253) | -3.91 units on a scale | Standard Error 0.398 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 16 (n=138, 193) | -4.28 units on a scale | Standard Error 0.425 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 20 (n=59, 99) | -4.49 units on a scale | Standard Error 0.676 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 2 and at Phase 2 Endpoint | Change from Baseline at Week 24 (n=22, 39) | -5.15 units on a scale | Standard Error 1.186 |
Secondary
Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2
The Y-MRS consists of 11 items: 1) Elevated Mood, 2) Increased Motor Activity -Energy, 3) Sexual Interest, 4) Sleep, 5) Irritability, 6) Speech (Rate and Amount), 7) Language -Thought Disorder, 8) Content, 9) Disruptive-Aggressive Behavior, 10) Appearance, 11) Insight. Seven items are rated on a 0 to 4 scale, while 4 items (items 5, 6, 8 and 9) are rated on a 0 to 8 scale (twice the weight of the other items.) For all items, 0 is the best rating and 4 or 8 is the worst rating. Total Score is the sum of the ratings for all 11 items. The possible Total Scores are from 0 (best) to 60 (worst).
Time frame: Baseline (end of ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 (Ph2) Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, + Confirmation of Partial Nonresponse Phase)
Population: Observed Cases (OC) data set; n=number of participants with measurement at given time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 8 (n=201, 287) | -16.18 units on a scale | Standard Error 0.495 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 20 (n=59, 99) | -20.37 units on a scale | Standard Error 1.213 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 6 (n=221, 305) | -13.92 units on a scale | Standard Error 0.514 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 24 (n=22, 39) | -20.82 units on a scale | Standard Error 1.55 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 12 (n=179, 253) | -17.74 units on a scale | Standard Error 0.528 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Ph2 endpoint (n=289, 383) | -14.78 units on a scale | Standard Error 0.53 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 4 (n=245, 326) | -12.11 units on a scale | Standard Error 0.454 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Baseline (n=289, 383) | 23.15 units on a scale | Standard Error 0.327 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 16 (n=138, 193) | -18.88 units on a scale | Standard Error 0.639 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 1 (n=277, 371) | -4.50 units on a scale | Standard Error 0.312 |
| Placebo | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 2 (n=266, 355) | -7.90 units on a scale | Standard Error 0.432 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 1 (n=277, 371) | -4.86 units on a scale | Standard Error 0.272 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 2 (n=266, 355) | -7.82 units on a scale | Standard Error 0.351 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 4 (n=245, 326) | -10.75 units on a scale | Standard Error 0.366 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 6 (n=221, 305) | -13.28 units on a scale | Standard Error 0.394 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 8 (n=201, 287) | -14.84 units on a scale | Standard Error 0.406 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 12 (n=179, 253) | -16.28 units on a scale | Standard Error 0.427 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 16 (n=138, 193) | -17.55 units on a scale | Standard Error 0.462 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 20 (n=59, 99) | -17.64 units on a scale | Standard Error 0.741 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Week 24 (n=22, 39) | -19.77 units on a scale | Standard Error 1.315 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Change from Baseline at Ph2 endpoint (n=289, 383) | -14.32 units on a scale | Standard Error 0.429 |
| Aripiprazole | Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 | Baseline (n=289, 383) | 22.32 units on a scale | Standard Error 0.252 |
Secondary
Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample
Time frame: Baseline
Population: Phase 2 Safety Sample; n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample | ALT (n=266, 346) | 20.0 U/L |
| Placebo | Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample | CK (n=266, 347) | 79.0 U/L |
| Placebo | Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample | AST (n=266, 346) | 19.0 U/L |
| Placebo | Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample | LD (n=262, 342) | 168.0 U/L |
| Placebo | Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample | ALP (n=265, 347) | 72.0 U/L |
| Aripiprazole | Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample | LD (n=262, 342) | 173.0 U/L |
| Aripiprazole | Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample | ALP (n=265, 347) | 64.0 U/L |
| Aripiprazole | Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample | ALT (n=266, 346) | 17.0 U/L |
| Aripiprazole | Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample | AST (n=266, 346) | 20.0 U/L |
| Aripiprazole | Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample | CK (n=266, 347) | 91.0 U/L |
Secondary
Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2
Time frame: Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample; n= participants with measurement at time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Supine Systolic BP (SBP) at Baseline (n=286, 372) | 120.0 mmHg |
| Placebo | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Supine SBP Change at Phase 2 Endpoint (n=286, 372) | 0.0 mmHg |
| Placebo | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Supine Diastolic BP (DBP) at Baseline(n=286, 372) | 76.0 mmHg |
| Placebo | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Supine DBP Change at Phase 2 Endpoint (n=286, 372) | 0.0 mmHg |
| Placebo | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Sitting SBP at Baseline (n=51, 67) | 120.0 mmHg |
| Placebo | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Sitting SBP Change at Phase 2 Endpoint (n=51, 67) | 0.0 mmHg |
| Placebo | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Sitting DBP at Baseline (n=51, 67) | 78.0 mmHg |
| Placebo | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Sitting DBP Change at Phase 2 Endpoint (n=51, 67) | 0.0 mmHg |
| Placebo | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Standing SBP at Baseline (n=260, 333) | 120.0 mmHg |
| Placebo | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Standing SBP Change at Phase 2 Endpoint(n=260,333) | 0.0 mmHg |
| Placebo | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Standing DBP at Baseline (n=260, 333) | 78.5 mmHg |
| Placebo | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Standing DBP Change at Phase 2 Endpoint(n=260,333) | 0.0 mmHg |
| Aripiprazole | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Standing DBP at Baseline (n=260, 333) | 78.0 mmHg |
| Aripiprazole | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Supine Systolic BP (SBP) at Baseline (n=286, 372) | 120.0 mmHg |
| Aripiprazole | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Sitting DBP at Baseline (n=51, 67) | 80.0 mmHg |
| Aripiprazole | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Supine SBP Change at Phase 2 Endpoint (n=286, 372) | 0.0 mmHg |
| Aripiprazole | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Standing SBP Change at Phase 2 Endpoint(n=260,333) | 0.0 mmHg |
| Aripiprazole | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Supine Diastolic BP (DBP) at Baseline(n=286, 372) | 77.5 mmHg |
| Aripiprazole | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Sitting DBP Change at Phase 2 Endpoint (n=51, 67) | 0.0 mmHg |
| Aripiprazole | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Supine DBP Change at Phase 2 Endpoint (n=286, 372) | 0.0 mmHg |
| Aripiprazole | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Standing DBP Change at Phase 2 Endpoint(n=260,333) | 0.0 mmHg |
| Aripiprazole | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Sitting SBP at Baseline (n=51, 67) | 120.0 mmHg |
| Aripiprazole | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Standing SBP at Baseline (n=260, 333) | 120.0 mmHg |
| Aripiprazole | Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 | Sitting SBP Change at Phase 2 Endpoint (n=51, 67) | 0.0 mmHg |
Secondary
Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3
Time frame: Baseline, Week 12, Week 24, Week 36, Week 52, Week 52 (LOCF), During Phase 3 (for lowest/highest values)
Population: Phase 3 Safety Sample; n=number of participants with measurement at time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 | Baseline (n=161, 160) | 27.0 kg/m^2 |
| Placebo | Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 | Change at Week 12 (n=129, 121) | 0.0 kg/m^2 |
| Placebo | Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 | Change at Week 24 (n=111, 118) | 0.1 kg/m^2 |
| Placebo | Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 | Change at Week 36 (n=89, 98) | 0.1 kg/m^2 |
| Placebo | Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 | Change at Week 52 (n=85, 95) | 0.5 kg/m^2 |
| Placebo | Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 | Change at Week 52 (LOCF) (n=161, 160) | 0.2 kg/m^2 |
| Placebo | Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 | Highest Value During Phase 3 (n=161, 160) | 0.4 kg/m^2 |
| Placebo | Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 | Lowest Value During Phase 3 (n=161, 160) | -0.4 kg/m^2 |
| Aripiprazole | Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 | Lowest Value During Phase 3 (n=161, 160) | -0.1 kg/m^2 |
| Aripiprazole | Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 | Baseline (n=161, 160) | 27.9 kg/m^2 |
| Aripiprazole | Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 | Change at Week 52 (n=85, 95) | 0.7 kg/m^2 |
| Aripiprazole | Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 | Change at Week 12 (n=129, 121) | 0.2 kg/m^2 |
| Aripiprazole | Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 | Highest Value During Phase 3 (n=161, 160) | 0.7 kg/m^2 |
| Aripiprazole | Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 | Change at Week 24 (n=111, 118) | 0.2 kg/m^2 |
| Aripiprazole | Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 | Change at Week 52 (LOCF) (n=161, 160) | 0.5 kg/m^2 |
| Aripiprazole | Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 | Change at Week 36 (n=89, 98) | 0.4 kg/m^2 |
Comparison: Treatment Comparison Baselinep-value: 0.646ANOVA/ANCOVA
Comparison: Week 12 Treatment Comparisonp-value: 0.006ANOVA/ANCOVA
Comparison: Week 24 Treatment Comparisonp-value: 0.485ANOVA/ANCOVA
Comparison: Week 36 Treatment Comparisonp-value: 0.325ANOVA/ANCOVA
Comparison: Week 52 Treatment Comparisonp-value: 0.374ANOVA/ANCOVA
Comparison: Week 52 (LOCF) Treatment Comparisonp-value: 0.064ANOVA/ANCOVA
Comparison: Highest Value Treatment Comparisonp-value: 0.31ANOVA/ANCOVA
Comparison: Lowest Value Treatment Comparisonp-value: 0.046ANOVA/ANCOVA
Secondary
Median Baseline and Change From Baseline in Body Mass Index (BMI) Vital Sign Measurements at Phase 2 Endpoint
Time frame: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample, participants with measurement at time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline and Change From Baseline in Body Mass Index (BMI) Vital Sign Measurements at Phase 2 Endpoint | BMI at Baseline | 26.9 kg/m^2 |
| Placebo | Median Baseline and Change From Baseline in Body Mass Index (BMI) Vital Sign Measurements at Phase 2 Endpoint | BMI Change at Phase 2 Endpoint | 0.3 kg/m^2 |
| Aripiprazole | Median Baseline and Change From Baseline in Body Mass Index (BMI) Vital Sign Measurements at Phase 2 Endpoint | BMI at Baseline | 27.2 kg/m^2 |
| Aripiprazole | Median Baseline and Change From Baseline in Body Mass Index (BMI) Vital Sign Measurements at Phase 2 Endpoint | BMI Change at Phase 2 Endpoint | 0.5 kg/m^2 |
Secondary
Median Baseline and Change From Baseline in ECG Measurements During Phase 2
Time frame: Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample; n= participants with measurement at time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | QTcBazett (QTcB) at Baseline (n=223, 285) | 415.0 msecs |
| Placebo | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | QTcB Change at Phase 2 Endpoint (n=223, 285) | 4.0 msecs |
| Placebo | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | QTcB (0.33) at Baseline (n=223, 284) | 403.0 msecs |
| Placebo | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | QTcB(0.33) Change at Phase 2 Endpoint (n=223, 284) | 4.0 msecs |
| Placebo | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | PR at Baseline (n=222, 284) | 154.0 msecs |
| Placebo | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | PR Change at Phase 2 Endpoint (n=222, 284) | 2.0 msecs |
| Placebo | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | RR at Baseline (n=223, 284) | 845.0 msecs |
| Placebo | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | RR Change at Phase 2 Endpoint (n=223, 284) | 0.0 msecs |
| Placebo | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | QRS at Baseline (n=223, 284) | 90.0 msecs |
| Placebo | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | QRS Change at Phase 2 Endpoint (n=223, 284) | 0.0 msecs |
| Aripiprazole | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | RR Change at Phase 2 Endpoint (n=223, 284) | 0.0 msecs |
| Aripiprazole | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | QTcBazett (QTcB) at Baseline (n=223, 285) | 412.0 msecs |
| Aripiprazole | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | PR Change at Phase 2 Endpoint (n=222, 284) | -2.0 msecs |
| Aripiprazole | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | QTcB Change at Phase 2 Endpoint (n=223, 285) | -8.0 msecs |
| Aripiprazole | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | QRS Change at Phase 2 Endpoint (n=223, 284) | -1.0 msecs |
| Aripiprazole | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | QTcB (0.33) at Baseline (n=223, 284) | 400.0 msecs |
| Aripiprazole | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | RR at Baseline (n=223, 284) | 870.0 msecs |
| Aripiprazole | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | QTcB(0.33) Change at Phase 2 Endpoint (n=223, 284) | -6.0 msecs |
| Aripiprazole | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | QRS at Baseline (n=223, 284) | 90.0 msecs |
| Aripiprazole | Median Baseline and Change From Baseline in ECG Measurements During Phase 2 | PR at Baseline (n=222, 284) | 150.0 msecs |
Secondary
Median Baseline and Change From Baseline in Heart Rate Measurements During Phase 2
Time frame: Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample; n= participants with measurement at time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline and Change From Baseline in Heart Rate Measurements During Phase 2 | Heart Rate at Baseline (n=223, 284) | 71.0 msecs |
| Placebo | Median Baseline and Change From Baseline in Heart Rate Measurements During Phase 2 | Heart Rate Change at Phase 2 Endpoint (n=223, 284) | 0.0 msecs |
| Aripiprazole | Median Baseline and Change From Baseline in Heart Rate Measurements During Phase 2 | Heart Rate at Baseline (n=223, 284) | 69.0 msecs |
| Aripiprazole | Median Baseline and Change From Baseline in Heart Rate Measurements During Phase 2 | Heart Rate Change at Phase 2 Endpoint (n=223, 284) | 0 msecs |
Secondary
Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2
Time frame: Baseline (end of Ph 1), Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample; n= participants with measurement at time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2 | Supine Heart Rate (HR) at Baseline (n=286, 372) | 76.0 beats per minute |
| Placebo | Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2 | Supine HR Change at Phase 2 Endpoint (n=286, 372) | 0.0 beats per minute |
| Placebo | Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2 | Sitting Heart Rate (HR) at Baseline (n=51, 67) | 78.0 beats per minute |
| Placebo | Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2 | Sitting HR Change at Phase 2 Endpoint (n=51, 67) | 2.0 beats per minute |
| Placebo | Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2 | Standing HR at Baseline (n=260, 333) | 78.0 beats per minute |
| Placebo | Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2 | Standing HR Change at Phase 2 Endpoint(n=260, 333) | 0.0 beats per minute |
| Aripiprazole | Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2 | Standing HR at Baseline (n=260, 333) | 78.0 beats per minute |
| Aripiprazole | Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2 | Supine Heart Rate (HR) at Baseline (n=286, 372) | 74.0 beats per minute |
| Aripiprazole | Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2 | Sitting HR Change at Phase 2 Endpoint (n=51, 67) | -2.0 beats per minute |
| Aripiprazole | Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2 | Supine HR Change at Phase 2 Endpoint (n=286, 372) | 0.0 beats per minute |
| Aripiprazole | Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2 | Standing HR Change at Phase 2 Endpoint(n=260, 333) | 0.0 beats per minute |
| Aripiprazole | Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2 | Sitting Heart Rate (HR) at Baseline (n=51, 67) | 82.0 beats per minute |
Secondary
Median Baseline and Change From Baseline in Weight Vital Sign Measurements At Phase 2 Endpoint
Time frame: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample, participants with measurement at time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline and Change From Baseline in Weight Vital Sign Measurements At Phase 2 Endpoint | Weight at Baseline | 76.2 kg |
| Placebo | Median Baseline and Change From Baseline in Weight Vital Sign Measurements At Phase 2 Endpoint | Weight Change at Phase 2 Endpoint | 0.9 kg |
| Aripiprazole | Median Baseline and Change From Baseline in Weight Vital Sign Measurements At Phase 2 Endpoint | Weight at Baseline | 76.4 kg |
| Aripiprazole | Median Baseline and Change From Baseline in Weight Vital Sign Measurements At Phase 2 Endpoint | Weight Change at Phase 2 Endpoint | 1.5 kg |
Secondary
Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid
Time frame: Baseline
Population: Phase 2 Safety Sample; n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | TC (n=245, 318) | 182.0 U/L |
| Placebo | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | LDL-C (n=245, 318) | 105.0 U/L |
| Placebo | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | Glucose (n=242, 312) | 92.0 U/L |
| Placebo | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | Bilirubin (n=265, 347) | 0.40 U/L |
| Placebo | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | Creatine (n=263, 343) | 0.900 U/L |
| Placebo | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | Triglycerides (n=245, 318) | 112.0 U/L |
| Placebo | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | HDL-C (n=245, 318) | 47.0 U/L |
| Placebo | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | Uric Acid (n=266, 347) | 5.55 U/L |
| Placebo | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | BUN (n=223, 302) | 11.0 U/L |
| Aripiprazole | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | Uric Acid (n=266, 347) | 5.10 U/L |
| Aripiprazole | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | BUN (n=223, 302) | 13.0 U/L |
| Aripiprazole | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | TC (n=245, 318) | 174.0 U/L |
| Aripiprazole | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | Creatine (n=263, 343) | 0.900 U/L |
| Aripiprazole | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | Glucose (n=242, 312) | 89.0 U/L |
| Aripiprazole | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | HDL-C (n=245, 318) | 45.0 U/L |
| Aripiprazole | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | LDL-C (n=245, 318) | 101.0 U/L |
| Aripiprazole | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | Bilirubin (n=265, 347) | 0.40 U/L |
| Aripiprazole | Median Baseline Blood Urea Nitrogen (BUN), Total Cholesterol-Fasting (TC), Creatine, Glucose, High Density Lipoprotein Cholesterol-Fasting (HDL-C), Low Density Lipoprotein Cholesterol-Fasting (LDL-C), Bilirubin-Total, Triglycerides, and Uric Acid | Triglycerides (n=245, 318) | 114.0 U/L |
Secondary
Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample | Baseline | 6.900 x 10^3 c/uL |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | 0.150 x 10^3 c/uL |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample | Highest Value of Change During Phase 3 | 1.100 x 10^3 c/uL |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample | Lowest Value of Change During Phase 3 | -0.900 x 10^3 c/uL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample | Lowest Value of Change During Phase 3 | -1.000 x 10^3 c/uL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample | Baseline | 7.650 x 10^3 c/uL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample | Highest Value of Change During Phase 3 | 1.100 x 10^3 c/uL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | -0.100 x 10^3 c/uL |
Comparison: Treatment Comparison Baseline Leukocytesp-value: 0.124Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from Baseline at Week 52 (LOCF)p-value: 0.295Wilcoxon Rank Sum Test
Comparison: Highest Value of Change in Leukocytes, Phase 3p-value: 0.735Wilcoxon Rank Sum Test
Comparison: Lowest Value of Change in Leukocytes, Phase 3p-value: 0.505Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample | Baseline | 252.0 x10^9 c/L |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | -1.0 x10^9 c/L |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample | Highest Value of Change During Phase 3 | 26.0 x10^9 c/L |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample | Lowest Value of Change During Phase 3 | -27.0 x10^9 c/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample | Lowest Value of Change During Phase 3 | -22.0 x10^9 c/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample | Baseline | 254.0 x10^9 c/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample | Highest Value of Change During Phase 3 | 17.5 x10^9 c/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | -3.5 x10^9 c/L |
Comparison: Treatment Comparison Baseline in Platelet Countp-value: 0.663Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from Baseline at Week 52 (LOCF)p-value: 0.322Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in Platelet Count, Phase 3 Safety Samplep-value: 0.358Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Lowest Value of Change in Platelet Count, Phase 3 Safety Samplep-value: 0.541Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3
Time frame: Baseline, During Phase 3 (for highest/lowest values), Week 52
Population: Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3 | Baseline | 80.0 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3 | Change from Baseline at Week 52 (LOCF) | 0.0 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3 | Highest Change Value During Phase 3 | 4.0 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3 | Lowest Change Value During Phase 3 | -4.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3 | Lowest Change Value During Phase 3 | -4.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3 | Baseline | 80.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3 | Highest Change Value During Phase 3 | 0.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3 | Change from Baseline at Week 52 (LOCF) | -2.0 mm Hg |
Comparison: Baseline Treatment Comparison; Aripiprazole/Placebop-value: 0.142Wilcoxon Rank Sum Test
Comparison: Week 52 LOCF Treatment Comparison; Aripiprazole/Placebop-value: 0.11Wilcoxon Rank Sum Test
Comparison: Highest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.022Wilcoxon Rank Sum Test
Comparison: Lowest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.542Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3
Time frame: Baseline, During Phase 3 (for highest/lowest values), Week 52
Population: Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3 | Baseline | 78.0 beats per minute ? |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3 | Change from Baseline at Week 52 (LOCF) | -4.0 beats per minute ? |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3 | Highest Change Value During Phase 3 | 3.0 beats per minute ? |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3 | Lowest Change Value During Phase 3 | -4.0 beats per minute ? |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3 | Lowest Change Value During Phase 3 | -2.0 beats per minute ? |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3 | Baseline | 76.0 beats per minute ? |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3 | Highest Change Value During Phase 3 | 4.0 beats per minute ? |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3 | Change from Baseline at Week 52 (LOCF) | -2.0 beats per minute ? |
Comparison: Baseline Treatment Comparison; Aripiprazole/Placebop-value: 0.916Wilcoxon Rank Sum Test
Comparison: Week 52 LOCF Treatment Comparison; Aripiprazole/Placebop-value: 0.707Wilcoxon Rank Sum Test
Comparison: Highest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.665Wilcoxon Rank Sum Test
Comparison: Lowest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.757Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3
Time frame: Baseline, During Phase 3 (for highest/lowest values), Week 52
Population: Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3 | Baseline | 120.0 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3 | Change from Baseline at Week 52 (LOCF) | 2.0 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3 | Highest Change Value During Phase 3 | 8.0 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3 | Lowest Change Value During Phase 3 | -3.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3 | Lowest Change Value During Phase 3 | -6.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3 | Baseline | 120.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3 | Highest Change Value During Phase 3 | 4.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3 | Change from Baseline at Week 52 (LOCF) | 0.0 mm Hg |
Comparison: Baseline Treatment Comparison; Aripiprazole/Placebop-value: 0.184Wilcoxon Rank Sum Test
Comparison: Week 52 LOCF Treatment Comparison; Aripiprazole/Placebop-value: 0.073Wilcoxon Rank Sum Test
Comparison: Highest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.02Wilcoxon Rank Sum Test
Comparison: Lowest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.206Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3
Time frame: Baseline, During Phase 3 (for highest/lowest values), Week 52
Population: Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3 | Baseline | 78.0 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3 | Change from Baseline at Week 52 (LOCF) | 0.0 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3 | Highest Change Value During Phase 3 | 6.0 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3 | Lowest Change Value During Phase 3 | -6.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3 | Lowest Change Value During Phase 3 | -6.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3 | Baseline | 78.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3 | Highest Change Value During Phase 3 | 6.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3 | Change from Baseline at Week 52 (LOCF) | 0.0 mm Hg |
Comparison: Baseline Treatment Comparison; Aripiprazole/Placebop-value: 0.935Wilcoxon Rank Sum Test
Comparison: Week 52 LOCF Treatment Comparison; Aripiprazole/Placebop-value: 0.174Wilcoxon Rank Sum Test
Comparison: Highest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.527Wilcoxon Rank Sum Test
Comparison: Lowest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.753Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3
Time frame: Baseline, During Phase 3 (for highest/lowest values), Week 52
Population: Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3 | Baseline | 78.0 beats per minute |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3 | Change from Baseline at Week 52 (LOCF) | 0.0 beats per minute |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3 | Highest Change Value During Phase 3 | 6.0 beats per minute |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3 | Lowest Change Value During Phase 3 | -7.0 beats per minute |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3 | Lowest Change Value During Phase 3 | -6.0 beats per minute |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3 | Baseline | 78.0 beats per minute |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3 | Highest Change Value During Phase 3 | 7.0 beats per minute |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3 | Change from Baseline at Week 52 (LOCF) | 1.0 beats per minute |
Comparison: Baseline Treatment Comparison; Aripiprazole/Placebop-value: 0.85Wilcoxon Rank Sum Test
Comparison: Week 52 LOCF Treatment Comparison; Aripiprazole/Placebop-value: 0.709Wilcoxon Rank Sum Test
Comparison: Highest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.326Wilcoxon Rank Sum Test
Comparison: Lowest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.201Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3
Time frame: Baseline, During Phase 3 (for highest/lowest values), Week 52
Population: Participants in Phase 3 Safety Sample with measurement; Week 52 LOCF
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3 | Baseline | 120.0 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3 | Change from Baseline at Week 52 (LOCF) | 0.0 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3 | Highest Change Value During Phase 3 | 8.0 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3 | Lowest Change Value During Phase 3 | -7.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3 | Lowest Change Value During Phase 3 | -8.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3 | Baseline | 120.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3 | Highest Change Value During Phase 3 | 6.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3 | Change from Baseline at Week 52 (LOCF) | 0.0 mm Hg |
Comparison: Baseline Treatment Comparison; Aripiprazole/Placebop-value: 0.871Wilcoxon Rank Sum Test
Comparison: Week 52 LOCF Treatment Comparison; Aripiprazole/Placebop-value: 0.362Wilcoxon Rank Sum Test
Comparison: Highest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.295Wilcoxon Rank Sum Test
Comparison: Lowest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.519Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3
Time frame: Baseline, During Phase 3 (for highest/lowest values), Week 52
Population: Phase 3 Safety Sample, Week 52 Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3 | Baseline | 78.0 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3 | Change from Baseline at Week 52 (LOCF) | 0.0 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3 | Highest Change Value During Phase 3 | 5.5 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3 | Lowest Change Value During Phase 3 | -6.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3 | Lowest Change Value During Phase 3 | -6.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3 | Baseline | 79.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3 | Highest Change Value During Phase 3 | 6.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3 | Change from Baseline at Week 52 (LOCF) | 0.0 mm Hg |
Comparison: Baseline Treatment Comparison; Aripiprazole/Placebop-value: 0.656Wilcoxon Rank Sum Test
Comparison: Week 52 LOCF Treatment Comparison; Aripiprazole/Placebop-value: 0.045Wilcoxon Rank Sum Test
Comparison: Highest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.532Wilcoxon Rank Sum Test
Comparison: Lowest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.578Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3
Time frame: Baseline, During Phase 3 (for highest/lowest values), Week 52
Population: Phase 3 Safety Sample, Week 52 Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3 | Baseline | 74.0 beats per minute (bpm) |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3 | Change from Baseline at Week 52 (LOCF) | 0.0 beats per minute (bpm) |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3 | Highest Change Value During Phase 3 | 7.5 beats per minute (bpm) |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3 | Lowest Change Value During Phase 3 | -5.5 beats per minute (bpm) |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3 | Lowest Change Value During Phase 3 | -5.0 beats per minute (bpm) |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3 | Baseline | 74.0 beats per minute (bpm) |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3 | Highest Change Value During Phase 3 | 8.0 beats per minute (bpm) |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3 | Change from Baseline at Week 52 (LOCF) | 1.0 beats per minute (bpm) |
Comparison: Baseline Treatment Comparison; Aripiprazole/Placebop-value: 0.619Wilcoxon Rank Sum Test
Comparison: Week 52 LOCF Treatment Comparison; Aripiprazole/Placebop-value: 0.868Wilcoxon Rank Sum Test
Comparison: Highest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.284Wilcoxon Rank Sum Test
Comparison: Lowest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.481Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3
Time frame: Baseline, During Phase 3 (for highest/lowest values), Week 52
Population: Phase 3 Safety Sample, Week 52 Last Observation Carried Forward (LOCF)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3 | Baseline | 120.0 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3 | Change from Baseline at Week 52 (LOCF) | 0.0 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3 | Highest Change Value During Phase 3 | 8.0 mm Hg |
| Placebo | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3 | Lowest Change Value During Phase 3 | -6.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3 | Lowest Change Value During Phase 3 | -8.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3 | Baseline | 120.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3 | Highest Change Value During Phase 3 | 6.0 mm Hg |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3 | Change from Baseline at Week 52 (LOCF) | 0.0 mm Hg |
Comparison: Baseline Treatment Comparison; Aripiprazole/Placebop-value: 0.64Wilcoxon Rank Sum Test
Comparison: Week 52 LOCF Treatment Comparison; Aripiprazole/Placebop-value: 0.423Wilcoxon Rank Sum Test
Comparison: Highest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.297Wilcoxon Rank Sum Test
Comparison: Lowest Value Treatment Comparison; Aripiprazole/Placebop-value: 0.707Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample | Baseline | 104.5 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample | Change from Baseline in Week 52 LOCF | 3.5 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample | Highest Value of Change During Phase 3 | 16.0 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample | Baseline | 100.0 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample | Change from Baseline in Week 52 LOCF | 0.0 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample | Highest Value of Change During Phase 3 | 16.5 mg/dL |
Comparison: Treatment Comparison Baseline LDL Cholesterol (fasting)p-value: 0.808Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from Baseline at Week 52 (LOCF)p-value: 0.507Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Change Value in LDL Cholesterol (fasting)p-value: 0.948Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample | Baseline | 60.5 U/L |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample | Change at Week 52 LOCF | 1.0 U/L |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 8.0 U/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample | Baseline | 62.5 U/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample | Change at Week 52 LOCF | 0.0 U/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 7.0 U/L |
Comparison: Treatment Comparison Baseline ALPp-value: 0.331Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from Baseline in ALP at Week 52 (LOCF)p-value: 0.353Wilcoxon Rank Sum Test
Comparison: Treatment Comparison ALP Highest Change Value During Phase 3p-value: 0.298Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample | Baseline | 19.5 U/L |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample | Change at Week 52 LOCF | -1.0 U/L |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 6.0 U/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample | Baseline | 20.0 U/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample | Change at Week 52 LOCF | 0.0 U/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 5.0 U/L |
Comparison: Treatment Comparison Baseline ALTp-value: 0.111Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change in ALT at Week 52 (LOCF)p-value: 0.948Wilcoxon Rank Sum Test
Comparison: Treatment Comparison ALT Highest Change Value During Phase 3p-value: 0.559Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample | Baseline | 20.0 U/L |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample | Change at Week 52 LOCF | 1.0 U/L |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 5.0 U/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample | Baseline | 22.0 U/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample | Change at Week 52 LOCF | -1.0 U/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 6.0 U/L |
Comparison: Treatment Comparison Baseline ASTp-value: 0.077Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change in AST at Week 52 (LOCF)p-value: 0.255Wilcoxon Rank Sum Test
Comparison: Treatment Comparison AST Highest Change Value During Phase 3p-value: 0.918Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample | Baseline | 11.0 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample | Change at Week 52 LOCF | 0.0 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 3.0 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample | Baseline | 12.0 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample | Change at Week 52 LOCF | 0.0 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 2.0 mg/dL |
Comparison: Treatment Comparison Baseline BUNp-value: 0.118Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from Baseline in BUN at Week 52 (LOCF)p-value: 0.532Wilcoxon Rank Sum Test
Comparison: Treatment Comparison BUN Highest Value of Change During Phase 3p-value: 0.169Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample | Baseline | 82.0 U/L |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample | Change at Week 52 LOCF | 5.0 U/L |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 33.0 U/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample | Baseline | 91.5 U/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample | Change at Week 52 LOCF | -2.0 U/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 28.0 U/L |
Comparison: Treatment Comparison Baseline Creatine Kinasep-value: 0.043Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from baseline in Creatine Kinase at Week 52 (LOCF)p-value: 0.019Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in Creatine Kinase During Phase 3p-value: 0.176Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample | Baseline | 0.900 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample | Change at Week 52 LOCF | 0.000 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 0.100 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 0.100 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample | Baseline | 0.900 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample | Change at Week 52 LOCF | 0.000 mg/dL |
Comparison: Treatment Comparison Baseline Creatininep-value: 0.105Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from Baseline in Creatinine at Week 52 (LOCF)p-value: 0.634Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in Creatinine During Phase 3p-value: 0.958Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample
The change values reported are the median of (post baseline percentage (of white blood cell count) minus baseline percentage (of white blood cell count).
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample | Baseline | 2.30 percent of total white blood cell count |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample | Change at Week 52 LOCF | 0.00 percent of total white blood cell count |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 0.80 percent of total white blood cell count |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample | Baseline | 2.20 percent of total white blood cell count |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample | Change at Week 52 LOCF | -0.10 percent of total white blood cell count |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 0.90 percent of total white blood cell count |
Comparison: Treatment Comparison Baseline Eosinophils (relative)p-value: 0.507Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from Baseline in Eosinophils (relative) at Week 52 (LOCF)p-value: 0.834Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in Eosinophils (relative) During Phase 3p-value: 0.511Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample | Baseline | 90.0 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample | Change at Week 52 LOCF | 0.0 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 6.0 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample | Baseline | 90.0 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample | Change at Week 52 LOCF | 0.0 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 7.0 mg/dL |
Comparison: Treatment Comparison Baseline Glucose (fasting)p-value: 0.741Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from Baseline in Glucose (fasting) at Week 52 (LOCF)p-value: 0.962Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Change Value in Glucose (fasting) During Phase 3p-value: 0.592Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample | Baseline | 70.0 bpm |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | 0.0 bpm |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample | Highest Value of Change in Heart Rate | 1.0 bpm |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample | Lowest Value of Change in Heart Rate | -3.0 bpm |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample | Lowest Value of Change in Heart Rate | -2.0 bpm |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample | Baseline | 69.0 bpm |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample | Highest Value of Change in Heart Rate | 3.0 bpm |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | 0.0 bpm |
Comparison: Treatment Comparison Baseline Heart Ratep-value: 0.587Wilcoxon Rank Sum Test
Comparison: Treatment Comparison, Change from Baseline in Heart Rate at Week 52 (LOCF)p-value: 0.386Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in Heart Rate, Phase 3p-value: 0.405Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Lowest Value of Change in Heart Rate, Phase 3p-value: 0.253Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample
HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.'
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample | Baseline | 1.24 proportion of 'normal function' |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | -0.13 proportion of 'normal function' |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample | Highest Value of Change During Phase 3 | 0.20 proportion of 'normal function' |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample | Baseline | 1.06 proportion of 'normal function' |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | -0.13 proportion of 'normal function' |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample | Highest Value of Change During Phase 3 | 0.37 proportion of 'normal function' |
Comparison: Treatment Comparison Baseline HOMA2-IRp-value: 0.55Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from Baseline in HOMA2-IR at Week 52 (LOCF)p-value: 0.554Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in HOMA2-IR, Phase 3 Safety Samplep-value: 0.87Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample
HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of 'normal function.'
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample | Baseline | 120.0 percentage of 'normal function' |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample | Change at Week 52 LOCF | -6.35 percentage of 'normal function' |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample | Highest Value of Change in Phase 3 | -10.85 percentage of 'normal function' |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample | Baseline | 106.90 percentage of 'normal function' |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample | Change at Week 52 LOCF | 8.50 percentage of 'normal function' |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 5.30 percentage of 'normal function' |
Comparison: Treatment Comparison Baseline HOMA2-Percent Betap-value: 0.349Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from Baseline in HOMA2-Percent Beta at Week 52 (LOCF)p-value: 0.624Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value in HOMA2-Percent Beta During Phase 3p-value: 0.329Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample | Baseline | 161.0 U/L |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample | Change at Week 52 LOCF | 4.0 U/L |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample | Highest Value of Change During Phase 3 | 25.0 U/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample | Baseline | 171.0 U/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample | Change at Week 52 LOCF | 0.0 U/L |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample | Highest Value of Change During Phase 3 | 19.0 U/L |
Comparison: Treatment Comparison Baseline Lactate Dehydrogenasep-value: 0.004Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Baseline Lactate Dehydrogenasep-value: 0.034Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in Lactate Dehydrogenase During Phase 3p-value: 0.091Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample | Baseline | 61.55 percent of total white blood cell count |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample | Change from Week 52 LOCF | -1.30 percent of total white blood cell count |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample | Highest Value of Change During Phase 3 | -6.45 percent of total white blood cell count |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample | Baseline | 62.60 percent of total white blood cell count |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample | Change from Week 52 LOCF | -0.55 percent of total white blood cell count |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample | Highest Value of Change During Phase 3 | -6.20 percent of total white blood cell count |
Comparison: Treatment Comparison Baseline Neutrophils (relative)p-value: 0.967Wilcoxon Rank Sum Test
Comparison: Treatment Comparison in change from Baseline in Neutrophils (relative) at Week 52 (LOCF)p-value: 0.486Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in Neutrophils (relative), Phase 3 Safety Samplep-value: 0.323Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample | Baseline | 7.0 ng/mL |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample | Change from Baseline in Week 52 LOCF | 2.0 ng/mL |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample | Highest Value of Change During Phase 3 | 3.0 ng/mL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample | Baseline | 6.0 ng/mL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample | Change from Baseline in Week 52 LOCF | 0.0 ng/mL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample | Highest Value of Change During Phase 3 | 1.0 ng/mL |
Comparison: Treatment Comparison Baseline Prolactinp-value: 0.412Wilcoxon Rank Sum Test
Comparison: Treatment Comparison, Change from Baseline at Week 52 (LOCF)p-value: <0.001Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in Prolactin, Phase 3 Safety Samplep-value: 0.004Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample | Baseline | 155.0 msecs |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | -2.0 msecs |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample | Highest Value of Change in PR | 2.0 msecs |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample | Baseline | 150.0 msecs |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | 0.0 msecs |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample | Highest Value of Change in PR | 4.0 msecs |
Comparison: Treatment Comparison Baseline PRp-value: 0.012Wilcoxon Rank Sum Test
Comparison: Treatment Comparison, Change from Baseline in PR at Week 52 (LOCF)p-value: 0.027Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in PR, Phase 3p-value: 0.128Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample | Baseline | 89.0 msecs |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | 0.0 msecs |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample | Highest Value of Change in QRS | 2.0 msecs |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample | Baseline | 90.0 msecs |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | 0.0 msecs |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample | Highest Value of Change in QRS | 2.0 msecs |
Comparison: Treatment Comparison Baseline QRSp-value: 0.826Wilcoxon Rank Sum Test
Comparison: Treatment Comparison, Change from Baseline in QRS at Week 52 (LOCF)p-value: 0.545Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in QRS, Phase 3p-value: 0.372Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample | Baseline | 404.0 msecs |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | 1.0 msecs |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample | Highest Value of Change in QTc (0.33) | 3.0 msecs |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample | Baseline | 400.0 msecs |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | 2.0 msecs |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample | Highest Value of Change in QTc (0.33) | 10.0 msecs |
Comparison: Treatment Comparison Baseline QTc (0.33)p-value: 0.205Wilcoxon Rank Sum Test
Comparison: Treatment Comparison, Change from Baseline in QTc (0.33) at Week 52 (LOCF)p-value: 0.669Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in QTc (0.33), Phase 3p-value: 0.072Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample | Baseline | 415.0 msecs |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | 3.0 msecs |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample | Highest Value of Change in QTc Bazett | 6.0 msecs |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample | Baseline | 410.0 msecs |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | 3.0 msecs |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample | Highest Value of Change in QTc Bazett | 12.0 msecs |
Comparison: Treatment Comparison Baseline QTc Bazettp-value: 0.213Wilcoxon Rank Sum Test
Comparison: Treatment Comparison, Change from Baseline in QTc Bazett at Week 52 (LOCF)p-value: 0.708Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in QTc Bazett, Phase 3p-value: 0.107Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample | Baseline | 857.0 msecs |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | 3.0 msecs |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample | Highest Value of Change in RR | 38.0 msecs |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample | Lowest Value of Change in RR | -15.0 msecs |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample | Lowest Value of Change in RR | -42.0 msecs |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample | Baseline | 870.0 msecs |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample | Highest Value of Change in RR | 20.0 msecs |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | -4.0 msecs |
Comparison: Treatment Comparison Baseline RRp-value: 0.571Wilcoxon Rank Sum Test
Comparison: Treatment Comparison, Change from Baseline in RR at Week 52 (LOCF)p-value: 0.353Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in RR, Phase 3 Safety Samplep-value: 0.204Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Lowest Value of Change in Prolactin, Phase 3 Safety Samplep-value: 0.435Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample | Baseline | 0.40 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | 0.00 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 0.10 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample | Baseline | 0.40 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | 0.00 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 0.10 mg/dL |
Comparison: Treatment Comparison Baseline Total Bilirubinp-value: 0.63Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from Baseline at Week 52 (LOCF)p-value: 0.675Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in Total Bilirubin, Phase 3 Safety Samplep-value: 0.592Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample | Baseline | 180.0 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample | Change at Week 52 LOCF | 5.0 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 18.5 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample | Baseline | 181.0 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample | Change at Week 52 LOCF | -0.5 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample | Highest Value of Change in Phase 3 | 20.5 mg/dL |
Comparison: Treatment Comparison Baseline Total Cholesterol (fasting)p-value: 0.878Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from Baseline in Total Cholesterol (fasting) at Week 52 (LOCF)p-value: 0.544Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in Total Cholesterol (fasting) in Phase 3p-value: 0.658Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample | Baseline | 130.0 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | 4.0 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample | Highest Value of Change During Phase 3 | 37.0 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample | Baseline | 134.5 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | 0.0 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample | Highest Value of Change During Phase 3 | 42.0 mg/dL |
Comparison: Treatment Comparison Baseline Triglycerides (fasting)p-value: 0.273Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from Baseline at Week 52 (LOCF)p-value: 0.489Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in Triglycerides (fasting), Phase 3 Safety Samplep-value: 0.415Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample | Baseline | 5.50 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | -0.10 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample | Highest Value of Change in Uric Acid | 0.65 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample | Baseline | 5.75 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample | Change from Baseline at Week 52 LOCF | 0.00 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample | Highest Value of Change in Uric Acid | 0.50 mg/dL |
Comparison: Treatment Comparison Baseline Uric Acidp-value: 0.189Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from Baseline at Week 52 (LOCF)p-value: 0.35Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Highest Value of Change in Uric Acid, Phase 3 Safety Samplep-value: 0.799Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample | Baseline | 46.0 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample | Change at Week 52 LOCF | -1.0 mg/dL |
| Placebo | Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample | Lowest Value of Change in Phase 3 | -5.0 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample | Baseline | 45.0 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample | Change at Week 52 LOCF | -1.0 mg/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample | Lowest Value of Change in Phase 3 | -5.0 mg/dL |
Comparison: Treatment Comparison Baseline HDL Cholesterol (fasting)p-value: 0.18Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from Baseline in HDL Cholesterol (fasting) at Week 52 (LOCF)p-value: 0.95Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Lowest Value of Change in HDL Cholesterol (fasting) During Phase 3p-value: 0.342Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample | Change at Week 52 LOCF | -0.40 percentage of total blood volume |
| Placebo | Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample | Baseline | 41.40 percentage of total blood volume |
| Placebo | Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample | Lowest Value of Change in Phase 3 | -1.60 percentage of total blood volume |
| Aripiprazole | Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample | Baseline | 42.15 percentage of total blood volume |
| Aripiprazole | Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample | Change at Week 52 LOCF | -0.30 percentage of total blood volume |
| Aripiprazole | Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample | Lowest Value of Change in Phase 3 | -1.90 percentage of total blood volume |
Comparison: Treatment Comparison Baseline Hematocritp-value: 0.187Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from Baseline in Hematocrit During Week 52 (LOCF)p-value: 0.377Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Lowest Value of Change in Hematocrit During Phase 3p-value: 0.494Wilcoxon Rank Sum Test
Secondary
Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample
Time frame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value)
Population: Phase 3 Safety Sample, participants with measurement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample | Baseline | 13.80 g/dL |
| Placebo | Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample | Change at Week 52 LOCF | -0.10 g/dL |
| Placebo | Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample | Lowest Value of Change in Phase 3 | -0.50 g/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample | Baseline | 14.00 g/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample | Change at Week 52 LOCF | -0.10 g/dL |
| Aripiprazole | Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample | Lowest Value of Change in Phase 3 | -0.60 g/dL |
Comparison: Treatment Comparison Baseline Hemoglobinp-value: 0.08Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Change from Baseline in Hemoglobin at Week 52 (LOCF)p-value: 0.868Wilcoxon Rank Sum Test
Comparison: Treatment Comparison Lowest Change Value in Hemoglobin During Phase 3p-value: 0.299Wilcoxon Rank Sum Test
Secondary
Median Baseline Eosinophils (Relative) and Neutrophils (Relative)
Time frame: Baseline
Population: Phase 2 Safety Sample; n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Baseline Eosinophils (Relative) and Neutrophils (Relative) | Eosinophils, relative (n=266, 347) | 2.50 percent of total white blood cell count |
| Placebo | Median Baseline Eosinophils (Relative) and Neutrophils (Relative) | Neutrophils, relative (n=266, 346) | 67.60 percent of total white blood cell count |
| Aripiprazole | Median Baseline Eosinophils (Relative) and Neutrophils (Relative) | Eosinophils, relative (n=266, 347) | 2.20 percent of total white blood cell count |
| Aripiprazole | Median Baseline Eosinophils (Relative) and Neutrophils (Relative) | Neutrophils, relative (n=266, 346) | 58.10 percent of total white blood cell count |
Secondary
Median Baseline Hematocrit
Time frame: Baseline
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Baseline Hematocrit | 41.30 percentage of total blood volume |
| Aripiprazole | Median Baseline Hematocrit | 41.10 percentage of total blood volume |
Secondary
Median Baseline Hemoglobin
Time frame: Baseline
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Baseline Hemoglobin | 13.75 g/dL |
| Aripiprazole | Median Baseline Hemoglobin | 13.80 g/dL |
Secondary
Median Baseline Homeostasis Model Assessment 2 HOMA2-Insulin Resistance (IR)
HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.'
Time frame: Baseline
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Baseline Homeostasis Model Assessment 2 HOMA2-Insulin Resistance (IR) | 1.14 proportion of 'normal function' |
| Aripiprazole | Median Baseline Homeostasis Model Assessment 2 HOMA2-Insulin Resistance (IR) | 1.42 proportion of 'normal function' |
Secondary
Median Baseline Homeostasis Model Assessment 2 (HOMA2)-Percent Beta
HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of 'normal function.'
Time frame: Baseline
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Baseline Homeostasis Model Assessment 2 (HOMA2)-Percent Beta | 99.95 percentage of 'normal function' |
| Aripiprazole | Median Baseline Homeostasis Model Assessment 2 (HOMA2)-Percent Beta | 118.70 percentage of 'normal function' |
Secondary
Median Baseline Leukocytes
Time frame: Baseline
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Baseline Leukocytes | 8.350 x10^3 c/L |
| Aripiprazole | Median Baseline Leukocytes | 6.800 x10^3 c/L |
Secondary
Median Baseline Platelet Count
Time frame: Baseline
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Baseline Platelet Count | 297.0 x10^9 c/L |
| Aripiprazole | Median Baseline Platelet Count | 226.0 x10^9 c/L |
Secondary
Median Baseline Prolactin
Time frame: Baseline
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Baseline Prolactin | 10.0 ng/dL |
| Aripiprazole | Median Baseline Prolactin | 9.5 ng/dL |
Secondary
Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2
Time frame: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample; n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2 | ALT (n=266, 346) | 0.0 U/L |
| Placebo | Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2 | CK (n=266, 347) | -1.0 U/L |
| Placebo | Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2 | AST (n=266, 346) | 0.0 U/L |
| Placebo | Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2 | LD (n=262, 342) | -3.0 U/L |
| Placebo | Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2 | ALP (n=265, 347) | -2.0 U/L |
| Aripiprazole | Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2 | LD (n=262, 342) | -1.0 U/L |
| Aripiprazole | Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2 | ALP (n=265, 347) | -2.0 U/L |
| Aripiprazole | Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2 | ALT (n=266, 346) | 2.0 U/L |
| Aripiprazole | Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2 | AST (n=266, 346) | 1.0 U/L |
| Aripiprazole | Median Change From Baseline in Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD) at the End of Phase 2 | CK (n=266, 347) | -2.0 U/L |
Secondary
Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2
Time frame: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample; n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | TC (n=245, 318) | -1.0 U/L |
| Placebo | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | LDL-C (n=245, 318) | -4.0 U/L |
| Placebo | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | Glucose (n=242, 312) | 2.0 U/L |
| Placebo | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | Bilirubin (n=265, 347) | 0.0 U/L |
| Placebo | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | Creatine (n=263, 343) | 0.0 U/L |
| Placebo | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | Triglycerides (n=245, 318) | 2.0 U/L |
| Placebo | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | HDL-C (n=245, 318) | -1.0 U/L |
| Placebo | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | Uric Acid (n=266, 347) | -0.10 U/L |
| Placebo | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | BUN (n=223, 302) | 0.0 U/L |
| Aripiprazole | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | Uric Acid (n=266, 347) | 0.10 U/L |
| Aripiprazole | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | BUN (n=223, 302) | 0.0 U/L |
| Aripiprazole | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | TC (n=245, 318) | 4.5 U/L |
| Aripiprazole | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | Creatine (n=263, 343) | 0.0 U/L |
| Aripiprazole | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | Glucose (n=242, 312) | 1.0 U/L |
| Aripiprazole | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | HDL-C (n=245, 318) | 1.0 U/L |
| Aripiprazole | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | LDL-C (n=245, 318) | 2.0 U/L |
| Aripiprazole | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | Bilirubin (n=265, 347) | 0.0 U/L |
| Aripiprazole | Median Change From Baseline in BUN, TC, Creatine, Glucose, HDL-C, LDL-C, Bilirubin-Total, Triglycerides, and Uric Acid at the End of Phase 2 | Triglycerides (n=245, 318) | 3.0 U/L |
Secondary
Median Change From Baseline in Eosinophils (Relative) and Neutrophils (Relative)
Time frame: Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample; n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Median Change From Baseline in Eosinophils (Relative) and Neutrophils (Relative) | Eosinophils, relative (n=266, 347) | -0.40 percent of total white blood cell count |
| Placebo | Median Change From Baseline in Eosinophils (Relative) and Neutrophils (Relative) | Neutrophils, relative (n=266, 346) | 0.25 percent of total white blood cell count |
| Aripiprazole | Median Change From Baseline in Eosinophils (Relative) and Neutrophils (Relative) | Eosinophils, relative (n=266, 347) | -0.20 percent of total white blood cell count |
| Aripiprazole | Median Change From Baseline in Eosinophils (Relative) and Neutrophils (Relative) | Neutrophils, relative (n=266, 346) | 0.60 percent of total white blood cell count |
Secondary
Median Change From Baseline in Hematocrit
Time frame: Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Change From Baseline in Hematocrit | 0.30 percentage of total blood volume |
| Aripiprazole | Median Change From Baseline in Hematocrit | 0.20 percentage of total blood volume |
Secondary
Median Change From Baseline in Hemoglobin
Time frame: Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Change From Baseline in Hemoglobin | 0.05 g/dL |
| Aripiprazole | Median Change From Baseline in Hemoglobin | 0.10 g/dL |
Secondary
Median Change From Baseline in HOMA2 Model Assesses Insulin Resistance (HOMA2-IR) at Phase 2 Endpoint
HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses insulin resistance (HOMA2-IR) relative to expected normal function (indexed to 1.0 for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-IR is a proportion of 'normal function.'
Time frame: Baseline (end of Ph 1), Phase 2 Endpoint (endpoint of a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Change From Baseline in HOMA2 Model Assesses Insulin Resistance (HOMA2-IR) at Phase 2 Endpoint | 0.09 proportion of 'normal function' |
| Aripiprazole | Median Change From Baseline in HOMA2 Model Assesses Insulin Resistance (HOMA2-IR) at Phase 2 Endpoint | 0.15 proportion of 'normal function' |
Secondary
Median Change From Baseline in Homeostasis Model Assessment 2(HOMA2)-Percent Beta at Phase 2 Endpoint
HOMA stands for homeostasis model assessment of insulin resistance and beta-cell function. These are model-based calculations that use fasting insulin and glucose concentrations in order to assess pancreatic beta-cell function and insulin resistance. The HOMA2 model assesses beta-cell function (HOMA2-%β) relative to expected normal function (indexed to 100% for normal function) and is based on predictions from experimental human data on the relationship between insulin and glucose in a fasted state. HOMA2-%Beta is a percentage of 'normal function.'
Time frame: Baseline (end of Ph 1), Phase 2 Endpoint (endpoint of a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Change From Baseline in Homeostasis Model Assessment 2(HOMA2)-Percent Beta at Phase 2 Endpoint | 7.70 percentage of 'normal function' |
| Aripiprazole | Median Change From Baseline in Homeostasis Model Assessment 2(HOMA2)-Percent Beta at Phase 2 Endpoint | 17.05 percentage of 'normal function' |
Secondary
Median Change From Baseline in Leukocytes at Phase 2 Endpoint
Time frame: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Change From Baseline in Leukocytes at Phase 2 Endpoint | -0.100 x10^3 c/L |
| Aripiprazole | Median Change From Baseline in Leukocytes at Phase 2 Endpoint | -0.200 x10^3 c/L |
Secondary
Median Change From Baseline in Platelet Count at Phase 2 Endpoint
Time frame: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Change From Baseline in Platelet Count at Phase 2 Endpoint | -4.0 x10^9 c/L |
| Aripiprazole | Median Change From Baseline in Platelet Count at Phase 2 Endpoint | -2.0 x10^9 c/L |
Secondary
Median Change From Baseline in Prolactin at Phase 2 Endpoint
Time frame: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Median Change From Baseline in Prolactin at Phase 2 Endpoint | -2.5 ng/dL |
| Aripiprazole | Median Change From Baseline in Prolactin at Phase 2 Endpoint | -3.0 ng/dL |
Secondary
Number of Participants Maintaining Remission During Phase 3
Remission is defined as Y-MRS Total Score \<=12 and MADRS Total Score \<=12.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Observed cases data set, Phase 3 Efficacy Sample
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Maintaining Remission During Phase 3 | Week 28 (n=114, 122) | 100 participants |
| Placebo | Number of Participants Maintaining Remission During Phase 3 | Week 16 (n=138, 131) | 122 participants |
| Placebo | Number of Participants Maintaining Remission During Phase 3 | Week 32 (n=104, 119) | 99 participants |
| Placebo | Number of Participants Maintaining Remission During Phase 3 | Week 4 (n=160, 162) | 142 participants |
| Placebo | Number of Participants Maintaining Remission During Phase 3 | Week 36 (n=99, 108) | 91 participants |
| Placebo | Number of Participants Maintaining Remission During Phase 3 | Week 20 (n=131, 127) | 115 participants |
| Placebo | Number of Participants Maintaining Remission During Phase 3 | Week 40 (n=100, 110) | 93 participants |
| Placebo | Number of Participants Maintaining Remission During Phase 3 | Week 12 (n=144, 136) | 133 participants |
| Placebo | Number of Participants Maintaining Remission During Phase 3 | Week 44 (n=91, 109) | 81 participants |
| Placebo | Number of Participants Maintaining Remission During Phase 3 | Week 24 (n=115, 122) | 107 participants |
| Placebo | Number of Participants Maintaining Remission During Phase 3 | Week 48 (n=92, 102) | 85 participants |
| Placebo | Number of Participants Maintaining Remission During Phase 3 | Week 52 (n=89, 97) | 82 participants |
| Placebo | Number of Participants Maintaining Remission During Phase 3 | Week 8 (n=152, 145) | 138 participants |
| Aripiprazole | Number of Participants Maintaining Remission During Phase 3 | Week 52 (n=89, 97) | 95 participants |
| Aripiprazole | Number of Participants Maintaining Remission During Phase 3 | Week 4 (n=160, 162) | 142 participants |
| Aripiprazole | Number of Participants Maintaining Remission During Phase 3 | Week 8 (n=152, 145) | 136 participants |
| Aripiprazole | Number of Participants Maintaining Remission During Phase 3 | Week 12 (n=144, 136) | 126 participants |
| Aripiprazole | Number of Participants Maintaining Remission During Phase 3 | Week 16 (n=138, 131) | 126 participants |
| Aripiprazole | Number of Participants Maintaining Remission During Phase 3 | Week 20 (n=131, 127) | 117 participants |
| Aripiprazole | Number of Participants Maintaining Remission During Phase 3 | Week 24 (n=115, 122) | 119 participants |
| Aripiprazole | Number of Participants Maintaining Remission During Phase 3 | Week 28 (n=114, 122) | 115 participants |
| Aripiprazole | Number of Participants Maintaining Remission During Phase 3 | Week 32 (n=104, 119) | 112 participants |
| Aripiprazole | Number of Participants Maintaining Remission During Phase 3 | Week 36 (n=99, 108) | 104 participants |
| Aripiprazole | Number of Participants Maintaining Remission During Phase 3 | Week 40 (n=100, 110) | 109 participants |
| Aripiprazole | Number of Participants Maintaining Remission During Phase 3 | Week 44 (n=91, 109) | 102 participants |
| Aripiprazole | Number of Participants Maintaining Remission During Phase 3 | Week 48 (n=92, 102) | 101 participants |
Comparison: Week 4p-value: 0.9195% CI: [0.92, 1.08]Cochran-Mantel-Haenszel
Comparison: Week 8p-value: 0.395% CI: [0.97, 1.11]Cochran-Mantel-Haenszel
Comparison: Week 12p-value: 0.74495% CI: [0.95, 1.08]Cochran-Mantel-Haenszel
Comparison: Week 16p-value: 0.01595% CI: [1.02, 1.17]Cochran-Mantel-Haenszel
Comparison: Week 20p-value: 0.26495% CI: [0.97, 1.14]Cochran-Mantel-Haenszel
Comparison: Week 24p-value: 0.0995% CI: [0.99, 1.11]Cochran-Mantel-Haenszel
Comparison: Week 28p-value: 0.05695% CI: [1, 1.17]Cochran-Mantel-Haenszel
Comparison: Week 32p-value: 0.75695% CI: [0.93, 1.05]Cochran-Mantel-Haenszel
Comparison: Week 36p-value: 0.17795% CI: [0.98, 1.13]Cochran-Mantel-Haenszel
Comparison: Week 40p-value: 0.02195% CI: [1.01, 1.13]Cochran-Mantel-Haenszel
Comparison: Week 44p-value: 0.21695% CI: [0.96, 1.16]Cochran-Mantel-Haenszel
Comparison: Week 48p-value: 0.01795% CI: [1.01, 1.15]Cochran-Mantel-Haenszel
Comparison: Week 52p-value: 0.08395% CI: [0.99, 1.13]Cochran-Mantel-Haenszel
Secondary
Number of Participants Showing Relevant Weight Gain During Phase 3
Relevant weight gain: \>=7% increase from baseline
Time frame: Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment)
Population: Phase 3 Safety Sample; n=number of participants with measurement at time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Showing Relevant Weight Gain During Phase 3 | Weight Gain at Week 12 (n=129, 121) | 3 Participants |
| Placebo | Number of Participants Showing Relevant Weight Gain During Phase 3 | Weight Gain at Week 24 (n=111, 118) | 6 Participants |
| Placebo | Number of Participants Showing Relevant Weight Gain During Phase 3 | Weight Gain at Week 36 (n=89, 98) | 16 Participants |
| Placebo | Number of Participants Showing Relevant Weight Gain During Phase 3 | Weight Gain at Week 52 (n=85, 95) | 16 Participants |
| Placebo | Number of Participants Showing Relevant Weight Gain During Phase 3 | Weight Gain at Week 52 (LOCF) (n=161, 160) | 19 Participants |
| Placebo | Number of Participants Showing Relevant Weight Gain During Phase 3 | Weight Gain at Any Time (n=163, 164) | 23 Participants |
| Aripiprazole | Number of Participants Showing Relevant Weight Gain During Phase 3 | Weight Gain at Week 52 (LOCF) (n=161, 160) | 22 Participants |
| Aripiprazole | Number of Participants Showing Relevant Weight Gain During Phase 3 | Weight Gain at Week 12 (n=129, 121) | 6 Participants |
| Aripiprazole | Number of Participants Showing Relevant Weight Gain During Phase 3 | Weight Gain at Week 52 (n=85, 95) | 18 Participants |
| Aripiprazole | Number of Participants Showing Relevant Weight Gain During Phase 3 | Weight Gain at Week 24 (n=111, 118) | 11 Participants |
| Aripiprazole | Number of Participants Showing Relevant Weight Gain During Phase 3 | Weight Gain at Any Time (n=163, 164) | 29 Participants |
| Aripiprazole | Number of Participants Showing Relevant Weight Gain During Phase 3 | Weight Gain at Week 36 (n=89, 98) | 12 Participants |
Comparison: Week 12 Treatment Comparisonp-value: 0.279Cochran-Mantel-Haenszel
Comparison: Week 24 Treatment Comparisonp-value: 0.247Cochran-Mantel-Haenszel
Comparison: Week 36 Treatment Comparisonp-value: 0.329Cochran-Mantel-Haenszel
Comparison: Week 52 Treatment Comparisonp-value: 0.928Cochran-Mantel-Haenszel
Comparison: Week 52 (LOCF) Treatment Comparisonp-value: 0.58495% CI: [0.66, 2.09]Cochran-Mantel-Haenszel
Comparison: At Any Time Treatment Comparisonp-value: 0.36995% CI: [0.76, 2.08]Cochran-Mantel-Haenszel
Secondary
Number of Participants Showing Relevant Weight Loss During Phase 3
Relevant weight loss: \>=7% decrease from baseline
Time frame: Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment)
Population: Phase 3 Safety Sample; n=number of participants with measurement at time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Showing Relevant Weight Loss During Phase 3 | Weight Gain at Week 24 (n=111, 118) | 7 Participants |
| Placebo | Number of Participants Showing Relevant Weight Loss During Phase 3 | Weight Gain at Week 12 (n=129, 121) | 5 Participants |
| Placebo | Number of Participants Showing Relevant Weight Loss During Phase 3 | Weight Gain at Week 36 (n=89, 98) | 7 Participants |
| Placebo | Number of Participants Showing Relevant Weight Loss During Phase 3 | Weight Gain at Week 52 (n=85, 95) | 7 Participants |
| Placebo | Number of Participants Showing Relevant Weight Loss During Phase 3 | Weight Gain at Week 52 (LOCF) (n=161, 160) | 13 Participants |
| Placebo | Number of Participants Showing Relevant Weight Loss During Phase 3 | Weight Gain at Any Time (n=163, 164) | 18 Participants |
| Aripiprazole | Number of Participants Showing Relevant Weight Loss During Phase 3 | Weight Gain at Week 52 (LOCF) (n=161, 160) | 10 Participants |
| Aripiprazole | Number of Participants Showing Relevant Weight Loss During Phase 3 | Weight Gain at Week 52 (n=85, 95) | 5 Participants |
| Aripiprazole | Number of Participants Showing Relevant Weight Loss During Phase 3 | Weight Gain at Week 12 (n=129, 121) | 6 Participants |
| Aripiprazole | Number of Participants Showing Relevant Weight Loss During Phase 3 | Weight Gain at Week 24 (n=111, 118) | 8 Participants |
| Aripiprazole | Number of Participants Showing Relevant Weight Loss During Phase 3 | Weight Gain at Any Time (n=163, 164) | 18 Participants |
| Aripiprazole | Number of Participants Showing Relevant Weight Loss During Phase 3 | Weight Gain at Week 36 (n=89, 98) | 8 Participants |
Comparison: Week 12 Treatment Comparisonp-value: 0.685Cochran-Mantel-Haenszel
Comparison: Week 24 Treatment Comparisonp-value: 0.792Cochran-Mantel-Haenszel
Comparison: Week 36 Treatment Comparisonp-value: 0.805Cochran-Mantel-Haenszel
Comparison: Week 52 Treatment Comparisonp-value: 0.533Cochran-Mantel-Haenszel
Comparison: Week 52 (LOCF) Treatment Comparisonp-value: 0.54595% CI: [0.35, 1.74]Cochran-Mantel-Haenszel
Comparison: At Any Time Treatment Comparisonp-value: 0.98795% CI: [0.54, 1.86]Cochran-Mantel-Haenszel
Secondary
Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3
Time frame: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Phase 3 Safety Sample
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3 | Cardiovascular System-Propanolol | 18 participants |
| Placebo | Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3 | Nervous System-Biperiden | 4 participants |
| Placebo | Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3 | Nervous System-Benztropine | 10 participants |
| Placebo | Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3 | Nervous System-Trihexyphenidyl | 11 participants |
| Placebo | Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3 | Any EPS Medications | 36 participants |
| Aripiprazole | Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3 | Nervous System-Trihexyphenidyl | 10 participants |
| Aripiprazole | Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3 | Any EPS Medications | 40 participants |
| Aripiprazole | Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3 | Cardiovascular System-Propanolol | 21 participants |
| Aripiprazole | Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3 | Nervous System-Benztropine | 19 participants |
| Aripiprazole | Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3 | Nervous System-Biperiden | 2 participants |
Secondary
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2
Sinus Tachycardia: ≥120bpm+↑≥15bpm+no current diagnosis of supraventricular (SV) or ventricular tachycardia or atrial fibrillation (AF) or flutter or other rhythm abnormality (RA). Sinus Bradycardia:≥50bpm+↓≥15bpm+no current diagnosis of AF or flutter or other RA. AF:not present→present or present at rate \<100bpm pretreatment to present with rate ≥100bpm+increase of ≥15bpm. AV=atrioventricular; PR=PR interval. Other Intraventricular Block: QRS wave ≥0.12 sec+↑≥0.02 sec+no current diagnosis of left or right bundle branch block. Old Infarction not present→present at ≥12 weeks post study entry.
Time frame: Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Pre-excitation Syndrome not present → present | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Atrial Fibrillation (see description) | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Other Intraventricular Block (see description) | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Bradycardia ≤ 50 bpm and ↓ 15 bpm | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Acute Infarction not present → present | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Atrial Flutter not present → present | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Subacute (Recent) Infarction not present → present | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Ventricular Premature Beat - not present → present | 2 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Old Infarction not present → present at >=12 weeks | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | 1st Degree AV Block PR ≥0.20 sec and ↑ ≥0.05 sec | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Myocardial Ischemia not present → present | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Sinus Bradycardia (see description) | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Symmetrical T-Wave Inversion not present → present | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | 2nd Degree AV Block not present → present | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | QTc Bazett (QTcB) > 450 msec | 15 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | SV Tachycardia not present → present | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | QTc Frederica (QTcF) > 450 msec | 5 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | 3rd Degree AV Block not present → present | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | QTcB > 500 msec | 2 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Sinus Tachycardia (see description) | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | QTcF > 500 msec | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Left Bundle Branch Block not present → present | 11 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | QTcB Change from Baseline > 30 msec | 28 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Ventricular Tachycardia not present → present | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | QTcF Change from Baseline > 30 msec | 21 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Right Bundle Branch Block not present → present | 5 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | QTcB Change from Baseline > 60 msec | 2 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | SV Premature Beat - not present → present | 2 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | QTcF Change from Baseline > 60 msec | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Tachycardia ≥ 120 bpm and ↑ ≥ 15 bpm | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | QTcF Change from Baseline > 60 msec | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Tachycardia ≥ 120 bpm and ↑ ≥ 15 bpm | 2 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Bradycardia ≤ 50 bpm and ↓ 15 bpm | 4 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Sinus Tachycardia (see description) | 2 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Sinus Bradycardia (see description) | 4 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | SV Premature Beat - not present → present | 2 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Ventricular Premature Beat - not present → present | 1 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | SV Tachycardia not present → present | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Ventricular Tachycardia not present → present | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Atrial Fibrillation (see description) | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Atrial Flutter not present → present | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | 1st Degree AV Block PR ≥0.20 sec and ↑ ≥0.05 sec | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | 2nd Degree AV Block not present → present | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | 3rd Degree AV Block not present → present | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Left Bundle Branch Block not present → present | 7 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Right Bundle Branch Block not present → present | 2 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Pre-excitation Syndrome not present → present | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Other Intraventricular Block (see description) | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Acute Infarction not present → present | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Subacute (Recent) Infarction not present → present | 1 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Old Infarction not present → present at >=12 weeks | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Myocardial Ischemia not present → present | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | Symmetrical T-Wave Inversion not present → present | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | QTc Bazett (QTcB) > 450 msec | 8 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | QTc Frederica (QTcF) > 450 msec | 2 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | QTcB > 500 msec | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | QTcF > 500 msec | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | QTcB Change from Baseline > 30 msec | 17 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | QTcF Change from Baseline > 30 msec | 11 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 | QTcB Change from Baseline > 60 msec | 4 Participants |
Secondary
Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3
Sinus Tachycardia: ≥120bpm+↑≥15bpm+no current diagnosis of supraventricular (SV) or ventricular tachycardia or atrial fibrillation (AF) or flutter or other rhythm abnormality (RA). Sinus Bradycardia:≥50bpm+↓≥15bpm+no current diagnosis of AF or flutter or other RA. AF:not present→present or present at rate \<100bpm pretreatment to present with rate ≥100bpm+increase of ≥15bpm. AV=atrioventricular; PR=PR interval. Other Intraventricular Block: QRS wave ≥0.12 sec+↑≥0.02 sec+no current diagnosis of left or right bundle branch block. Old Infarction not present→present at ≥12 weeks post study entry.
Time frame: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Phase 3 Safety Sample
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Pre-excitation Syndrome not present → present | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Atrial Fibrillation (see description) | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Other Intraventricular Block (see description) | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Bradycardia ≤ 50 bpm and ↓ 15 bpm | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Acute Infarction not present → present | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Atrial Flutter not present → present | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Subacute (Recent) Infarction not present → present | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Ventricular Premature Beat - not present → present | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Old Infarction (see description) | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | 1st Degree AV Block PR ≥0.20 sec and ↑ ≥0.05 sec | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Myocardial Ischemia not present → present | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Sinus Bradycardia (see description) | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Symmetrical T-Wave Inversion not present → present | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | 2nd Degree AV Block not present → present | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | QTc Bazett (QTcB) > 450 msec | 12 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | SV Tachycardia not present → present | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | QTc Frederica (QTcF) > 450 msec | 5 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | 3rd Degree AV Block not present → present | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | QTcB > 500 msec | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Sinus Tachycardia (see description) | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | QTcF > 500 msec | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Left Bundle Branch Block not present → present | 12 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | QTcB Change from Baseline > 30 msec | 20 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Ventricular Tachycardia not present → present | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | QTcF Change from Baseline > 30 msec | 10 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Right Bundle Branch Block not present → present | 6 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | QTcB Change from Baseline > 60 msec | 3 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | SV Premature Beat - not present → present | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | QTcF Change from Baseline > 60 msec | 2 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Tachycardia ≥ 120 bpm and ↑ ≥ 15 bpm | 1 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | QTcF Change from Baseline > 60 msec | 3 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Tachycardia ≥ 120 bpm and ↑ ≥ 15 bpm | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Bradycardia ≤ 50 bpm and ↓ 15 bpm | 1 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Sinus Tachycardia (see description) | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Sinus Bradycardia (see description) | 1 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | SV Premature Beat - not present → present | 1 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Ventricular Premature Beat - not present → present | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | SV Tachycardia not present → present | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Ventricular Tachycardia not present → present | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Atrial Fibrillation (see description) | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Atrial Flutter not present → present | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | 1st Degree AV Block PR ≥0.20 sec and ↑ ≥0.05 sec | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | 2nd Degree AV Block not present → present | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | 3rd Degree AV Block not present → present | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Left Bundle Branch Block not present → present | 9 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Right Bundle Branch Block not present → present | 3 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Pre-excitation Syndrome not present → present | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Other Intraventricular Block (see description) | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Acute Infarction not present → present | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Subacute (Recent) Infarction not present → present | 2 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Old Infarction (see description) | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Myocardial Ischemia not present → present | 2 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | Symmetrical T-Wave Inversion not present → present | 1 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | QTc Bazett (QTcB) > 450 msec | 15 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | QTc Frederica (QTcF) > 450 msec | 4 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | QTcB > 500 msec | 1 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | QTcF > 500 msec | 1 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | QTcB Change from Baseline > 30 msec | 25 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | QTcF Change from Baseline > 30 msec | 20 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 | QTcB Change from Baseline > 60 msec | 4 Participants |
Secondary
Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2
ULN=upper limit of normal; HDL=high density lipoprotein; LDL=low density lipoprotein. Values for ULN are provided by the lab in the database and could be different for each individual patient based on characteristics such as age, gender, or other patient attributes.
Time frame: Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample; n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Neutrophils Relative (Calculated) ≤15%(n=272, 358) | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Creatinine ≥ 2.0 mg/dL (n=271, 359) | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Platelets ≤75,000 mm^3/≥700,000 mm^3 (n=268, 357) | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Total Calcium ≤8.2 mg/dL or ≥12 mg/dL (n=273, 360) | 2 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Urine Glucose-any glucose in the urine(n=269,357) | 7 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Blood Urea Nitrogen ≥ 30 mg/dL (n=225, 312) | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Urine Protein Increase of ≥ 2 units (n=269, 357) | 10 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Chloride Serum ≤90 mEq/L or ≥118 mEq/L(n=273, 360) | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Glucose (Non-fasting) ≥200 mg/dL (n=78, 89) | 2 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Lactate Dehydrogenase >= 3 x ULN (n=270, 358) | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Glucose (Fasting) ≥ 126 mg/dL (n=251, 332) | 42 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Potassium Serum ≤2.5 mEq/L/≥6.5 mEq/L(n=271, 358) | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | HDL Cholesterol (combined) <40 mg/dL (n=273, 360) | 94 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Aspartate Aminotransferase ≥ 3 x ULN (n=273, 359) | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | HDL Cholesterol (Fasting) <40 mg/dL (n=252, 332) | 85 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Sodium Serum ≤126 mEq/L/≥156 mEq/L (n=273, 360) | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | HDL Cholesterol (Non-fasting) <40 mg/dL (n=79, 91) | 20 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Prolactin > ULN (n=231, 306) | 10 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Total Cholesterol (Combined) ≥240 mg/dL(n=273,360) | 37 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Hematocrit ≤37(M)/≤32(F)+3 pts↓from BL(n=272, 358) | 5 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Total Cholesterol (Fasting) ≥240 mg/dL (n=252,332) | 32 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Creatine Kinase >= 3 x ULN (n=273, 360) | 6 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Total Cholesterol (Non-fasting) ≥240mg/dL(n=79,92) | 7 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Hemoglobin ≤11.5 g/dL(M)/≤9.5 g/dL(F) (n=272, 359) | 8 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | LDL Cholesterol (Combined) ≥160 mg/dL (n=273, 360) | 30 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Bilirubin Total ≥ 2.0 mg/dL (n=n=272, 360) | 2 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | LDL Cholesterol (Fasting) ≥160 mg/dL (n=252, 332) | 28 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Leukocytes <=2800 mm^3 or >=16000 mm^3(n=272, 358) | 9 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | LDL Cholesterol (Non-fasting) ≥160 mg/dL (n=79,91) | 4 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Alanine Aminotransferase ≥ 3 x ULN (n=273, 359) | 3 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Triglycerides (Combined) ≥ 200 mg/dL (n=273, 360) | 88 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Eosinophils Relative (Calculated) ≥10%(n=272, 358) | 9 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Triglycerides (Non-Fasting) ≥ 200 mg/dL (n=79, 93) | 25 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Uric Acid ≥10.5mg/dL(M)/≥8.5mg/dL(F) (n=273, 360) | 10 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Triglycerides (Fasting) ≥ 200 mg/dL (n=252, 332) | 73 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Alkaline Phosphatase ≥ 3 x ULN (n=272, 360) | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Triglycerides (Fasting) ≥ 200 mg/dL (n=252, 332) | 85 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Alkaline Phosphatase ≥ 3 x ULN (n=272, 360) | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Alanine Aminotransferase ≥ 3 x ULN (n=273, 359) | 6 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Aspartate Aminotransferase ≥ 3 x ULN (n=273, 359) | 3 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Blood Urea Nitrogen ≥ 30 mg/dL (n=225, 312) | 7 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Creatine Kinase >= 3 x ULN (n=273, 360) | 20 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Creatinine ≥ 2.0 mg/dL (n=271, 359) | 1 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Lactate Dehydrogenase >= 3 x ULN (n=270, 358) | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Prolactin > ULN (n=231, 306) | 9 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Bilirubin Total ≥ 2.0 mg/dL (n=n=272, 360) | 1 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Uric Acid ≥10.5mg/dL(M)/≥8.5mg/dL(F) (n=273, 360) | 7 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Total Calcium ≤8.2 mg/dL or ≥12 mg/dL (n=273, 360) | 13 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Chloride Serum ≤90 mEq/L or ≥118 mEq/L(n=273, 360) | 4 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Potassium Serum ≤2.5 mEq/L/≥6.5 mEq/L(n=271, 358) | 1 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Sodium Serum ≤126 mEq/L/≥156 mEq/L (n=273, 360) | 2 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Hematocrit ≤37(M)/≤32(F)+3 pts↓from BL(n=272, 358) | 4 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Hemoglobin ≤11.5 g/dL(M)/≤9.5 g/dL(F) (n=272, 359) | 3 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Leukocytes <=2800 mm^3 or >=16000 mm^3(n=272, 358) | 2 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Eosinophils Relative (Calculated) ≥10%(n=272, 358) | 12 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Neutrophils Relative (Calculated) ≤15%(n=272, 358) | 1 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Platelets ≤75,000 mm^3/≥700,000 mm^3 (n=268, 357) | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Urine Glucose-any glucose in the urine(n=269,357) | 13 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Urine Protein Increase of ≥ 2 units (n=269, 357) | 6 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Glucose (Non-fasting) ≥200 mg/dL (n=78, 89) | 3 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Glucose (Fasting) ≥ 126 mg/dL (n=251, 332) | 28 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | HDL Cholesterol (combined) <40 mg/dL (n=273, 360) | 131 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | HDL Cholesterol (Fasting) <40 mg/dL (n=252, 332) | 117 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | HDL Cholesterol (Non-fasting) <40 mg/dL (n=79, 91) | 31 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Total Cholesterol (Combined) ≥240 mg/dL(n=273,360) | 53 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Total Cholesterol (Fasting) ≥240 mg/dL (n=252,332) | 49 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Total Cholesterol (Non-fasting) ≥240mg/dL(n=79,92) | 11 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | LDL Cholesterol (Combined) ≥160 mg/dL (n=273, 360) | 47 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | LDL Cholesterol (Fasting) ≥160 mg/dL (n=252, 332) | 44 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | LDL Cholesterol (Non-fasting) ≥160 mg/dL (n=79,91) | 8 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Triglycerides (Combined) ≥ 200 mg/dL (n=273, 360) | 108 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 | Triglycerides (Non-Fasting) ≥ 200 mg/dL (n=79, 93) | 33 Participants |
Secondary
Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3
ULN=upper limit of normal; Hb=hemoglobin
Time frame: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Phase 3 Safety Sample; n=number of participants with measurement
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Neutrophils Relative (Calculated) ≤15 (n=166, 164) | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Creatinine ≥ 2.0 mg/dL (n=166,164) | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Platelet Count (n=165, 162) | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Total Calcium ≤8.2 mg/dL or ≥12 mg/dL (n=166, 165) | 4 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Urine Glucose (n=166, 165) | 8 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Blood Urea Nitrogen ≥ 30 mg/dL (n=139, 138) | 3 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Urine Protein (n=166, 165) | 5 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Chloride Serum ≤90 mEq/L or ≥118 mEq/L(n=166, 165) | 1 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Glucose (non-fasting) (n=38, 28) | 1 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Lactate Dehydrogenase (n=166,164) | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Glucose (fasting) (n=159, 158) | 26 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Potassium Serum ≤2.5 or ≥6.5 mEq/L (n=166, 164) | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | HDL Cholesterol (combined) (n=166, 165) | 81 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Aspartate Aminotransferase ≥ 3 x ULN (n=166,165) | 0 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | HDL Cholesterol (fasting) (n=160, 159) | 76 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Sodium Serum ≤126 or ≥156 mEq/L (n=166, 165) | 1 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | HDL Cholesterol (non-fasting) (n=38, 27) | 20 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Prolactin > ULN (n=163, 158) | 14 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Total Cholesterol (combined) (n=166, 165) | 28 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Hematocrit ≤37(M) or ≤32(F)3 poi (n=166, 164) | 7 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Total Cholesterol (fasting) (n=160, 159) | 27 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Creatine Kinase (n=166,165) | 8 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Total Cholesterol (non-fasting) (n=38, 27) | 3 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Hb ≤11.5 g/dl (M) / ≤9.5 g/dL (F) (n=166, 164) | 2 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | LDL Cholesterol (combined) (n=166, 165) | 24 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Bilirubin Total ≥ 2.0 mg/dL (n=166, 165) | 2 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | LDL Cholesterol (fasting) (n=160, 159) | 24 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Leukocytes (n=166, 164) | 5 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | LDL Cholesterol (non-fasting) (n=38, 27) | 1 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Alanine Aminotransferase ≥ 3 x ULN (n=166,165) | 3 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Triglycerides (combined) (n=166, 165) | 59 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Eosinophils Relative (Calculated) ≥10 (n=166, 164) | 6 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Triglycerides (non-fasting) (n=38, 28) | 16 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Uric Acid≥10.5 mg/dL(M)/≥ 8.5 mg/dL(F)(n=166, 165) | 4 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Triglycerides (fasting) (n=160,159) | 48 participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Alkaline Phosphatase ≥ 3 x ULN (n=166,165) | 2 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Triglycerides (fasting) (n=160,159) | 63 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Alkaline Phosphatase ≥ 3 x ULN (n=166,165) | 0 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Alanine Aminotransferase ≥ 3 x ULN (n=166,165) | 3 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Aspartate Aminotransferase ≥ 3 x ULN (n=166,165) | 0 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Blood Urea Nitrogen ≥ 30 mg/dL (n=139, 138) | 1 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Creatine Kinase (n=166,165) | 6 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Creatinine ≥ 2.0 mg/dL (n=166,164) | 1 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Lactate Dehydrogenase (n=166,164) | 0 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Prolactin > ULN (n=163, 158) | 14 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Bilirubin Total ≥ 2.0 mg/dL (n=166, 165) | 3 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Uric Acid≥10.5 mg/dL(M)/≥ 8.5 mg/dL(F)(n=166, 165) | 7 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Total Calcium ≤8.2 mg/dL or ≥12 mg/dL (n=166, 165) | 7 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Chloride Serum ≤90 mEq/L or ≥118 mEq/L(n=166, 165) | 1 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Potassium Serum ≤2.5 or ≥6.5 mEq/L (n=166, 164) | 3 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Sodium Serum ≤126 or ≥156 mEq/L (n=166, 165) | 1 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Hematocrit ≤37(M) or ≤32(F)3 poi (n=166, 164) | 8 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Hb ≤11.5 g/dl (M) / ≤9.5 g/dL (F) (n=166, 164) | 4 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Leukocytes (n=166, 164) | 3 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Eosinophils Relative (Calculated) ≥10 (n=166, 164) | 11 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Neutrophils Relative (Calculated) ≤15 (n=166, 164) | 0 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Platelet Count (n=165, 162) | 0 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Urine Glucose (n=166, 165) | 8 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Urine Protein (n=166, 165) | 4 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Glucose (non-fasting) (n=38, 28) | 0 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Glucose (fasting) (n=159, 158) | 27 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | HDL Cholesterol (combined) (n=166, 165) | 91 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | HDL Cholesterol (fasting) (n=160, 159) | 88 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | HDL Cholesterol (non-fasting) (n=38, 27) | 11 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Total Cholesterol (combined) (n=166, 165) | 38 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Total Cholesterol (fasting) (n=160, 159) | 35 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Total Cholesterol (non-fasting) (n=38, 27) | 7 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | LDL Cholesterol (combined) (n=166, 165) | 23 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | LDL Cholesterol (fasting) (n=160, 159) | 22 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | LDL Cholesterol (non-fasting) (n=38, 27) | 3 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Triglycerides (combined) (n=166, 165) | 67 participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 | Triglycerides (non-fasting) (n=38, 28) | 15 participants |
Secondary
Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2
Heart Rate: increase, ≥120 beats per minute (bpm) and ≥15 relative to baseline (RBL); decrease, ≤50 bpm and ≥15 RBL. Systolic BP: increase, ≥180 mmHg and ≥20 RBL; decrease, ≤90 mmHg and ≥20 RBL. Diastolic BP: increase, ≥105 mmHg and ≥15 RBL; decrease, ≤50 mmHg and ≥15 RBL. For patients missing a baseline value, an on-treatment value was considered potentially clinically relevant if the value meets the criterion value.
Time frame: Phase 2 (a 13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Systolic Blood Pressure (SBP) - Standing Increase | 2 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | SBP - Standing Decrease | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | SBP - Supine Increase | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | SBP - Supine Decrease | 2 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | SBP - Sitting Increase | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | SBP - Sitting Decrease | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Diastolic Blood Pressure (DBP) - Standing Increase | 4 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | DBP - Standing Decrease | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | DBP - Supine Increase | 2 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | DBP - Supine Decrease | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | DBP - Sitting Increase | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | DBP - Sitting Decrease | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Heart Rate - Standing Increase | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Heart Rate - Standing Decrease | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Heart Rate - Supine Increase | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Heart Rate - Supine Decrease | 1 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Heart Rate - Sitting Increase | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Heart Rate - Sitting Decrease | 0 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Weight - Increase | 26 Participants |
| Placebo | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Weight - Decrease | 15 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Heart Rate - Sitting Decrease | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Systolic Blood Pressure (SBP) - Standing Increase | 4 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | DBP - Sitting Increase | 3 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | SBP - Standing Decrease | 4 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Heart Rate - Supine Decrease | 1 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | SBP - Supine Increase | 6 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | DBP - Sitting Decrease | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | SBP - Supine Decrease | 4 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Weight - Decrease | 6 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | SBP - Sitting Increase | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Heart Rate - Standing Increase | 2 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | SBP - Sitting Decrease | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Heart Rate - Sitting Increase | 1 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Diastolic Blood Pressure (DBP) - Standing Increase | 7 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Heart Rate - Standing Decrease | 0 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | DBP - Standing Decrease | 3 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Weight - Increase | 46 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | DBP - Supine Increase | 5 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | Heart Rate - Supine Increase | 1 Participants |
| Aripiprazole | Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 | DBP - Supine Decrease | 3 Participants |
Secondary
Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3
Heart Rate: increase, ≥120 beats per minute (bpm) and ≥15 relative to baseline (RBL); decrease, ≤50 bpm and ≥15 RBL. Systolic BP: increase, ≥180 mmHg and ≥20 RBL; decrease, ≤90 mmHg and ≥20 RBL. Diastolic BP: increase, ≥105 mmHg and ≥15 RBL; decrease, ≤50 mmHg and ≥15 RBL. For patients missing a baseline value, an on-treatment value was considered potentially clinically relevant if the value meets the criterion value.
Time frame: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Phase 3 Safety Sample; n= number of participants with measurement
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | SBP- Standing Increase (n=145, 147) | 0 Participants |
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | SBP- Standing Decrease (n=145, 147) | 2 Participants |
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | SBP- Supine Increase (n=165, 164) | 0 Participants |
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | SBP- Supine Decrease (n=165, 164) | 2 Participants |
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | SBP- Sitting Increase (n=41, 47) | 0 Participants |
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | SBP- Sitting Decrease (n=41, 47) | 0 Participants |
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | DBP- Standing Increase (n=145, 147) | 5 Participants |
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | DBP- Standing Decrease (n=145, 147) | 0 Participants |
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | DBP- Supine Increase (n=165, 164) | 4 Participants |
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | DBP- Supine Decrease (n=165, 164) | 1 Participants |
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | DBP- Sitting Increase (n=41, 47) | 1 Participants |
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | DBP- Sitting Decrease (n=41, 47) | 0 Participants |
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | HR- Standing Increase (n=145, 147) | 1 Participants |
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | HR- Standing Decrease (n=145, 147) | 2 Participants |
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | HR- Supine Increase (n=165, 164) | 0 Participants |
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | HR- Supine Decrease (n=165, 164) | 1 Participants |
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | HR- Sitting Increase (n=41, 47) | 0 Participants |
| Placebo | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | HR- Sitting Decrease (n=41, 47) | 0 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | HR- Standing Decrease (n=145, 147) | 0 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | SBP- Standing Increase (n=145, 147) | 0 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | DBP- Supine Decrease (n=165, 164) | 2 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | SBP- Standing Decrease (n=145, 147) | 1 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | HR- Sitting Decrease (n=41, 47) | 1 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | SBP- Supine Increase (n=165, 164) | 0 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | DBP- Sitting Increase (n=41, 47) | 0 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | SBP- Supine Decrease (n=165, 164) | 2 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | HR- Supine Increase (n=165, 164) | 0 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | SBP- Sitting Increase (n=41, 47) | 0 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | DBP- Sitting Decrease (n=41, 47) | 0 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | SBP- Sitting Decrease (n=41, 47) | 1 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | HR- Sitting Increase (n=41, 47) | 0 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | DBP- Standing Increase (n=145, 147) | 1 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | HR- Standing Increase (n=145, 147) | 1 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | DBP- Standing Decrease (n=145, 147) | 2 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | HR- Supine Decrease (n=165, 164) | 1 Participants |
| Aripiprazole | Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 | DBP- Supine Increase (n=165, 164) | 3 Participants |
Secondary
Proportion of Participants Discontinuing For Any Reason Through Week 52 (During Phase 3)
Time frame: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Randomized Sample
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Proportion of Participants Discontinuing For Any Reason Through Week 52 (During Phase 3) | 0.473 Proportion of Participants |
| Aripiprazole | Proportion of Participants Discontinuing For Any Reason Through Week 52 (During Phase 3) | 0.387 Proportion of Participants |
p-value: 0.13295% CI: [0.56, 1.08]Stratified Log Rank Test
Secondary
Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3
Kaplan Meier estimated survival rate. Relapse is defined as any of the following events accompanied by a YMRS \> 16 and/or a MADRS \> 16; serious adverse event of worsening disease, or discontinuation by the investigator for lack of efficacy. A hospitalization for a manic, mixed, or depressive episode does meet the criteria for relapse, however does not require an accompanying Y-MRS and/or MADRS score \> 16.
Time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3
Population: Randomized sample, n=number of participants at risk at given time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 0 (n=169, 168) | 1.00 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 4 (n=153, 148) | 0.96 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 8 (n=148, 139) | 0.94 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 12 (n=142, 133) | 0.94 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 16 (n=132, 130) | 0.93 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 20 (n=123, 128) | 0.92 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 24 (n=115, 125) | 0.92 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 28 (n=107, 121) | 0.89 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 32 (n=104, 114) | 0.89 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 36 (n=101, 111) | 0.89 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 40 (n=98, 110) | 0.88 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 44 (n=94, 107) | 0.88 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 48 (n=91, 98) | 0.87 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 52 (n=6, 8) | 0.87 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 40 (n=98, 110) | 0.91 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 0 (n=169, 168) | 1.00 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 28 (n=107, 121) | 0.95 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 4 (n=153, 148) | 0.98 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 48 (n=91, 98) | 0.90 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 8 (n=148, 139) | 0.97 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 32 (n=104, 114) | 0.91 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 12 (n=142, 133) | 0.97 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 44 (n=94, 107) | 0.91 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 16 (n=132, 130) | 0.96 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 36 (n=101, 111) | 0.91 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 20 (n=123, 128) | 0.96 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 52 (n=6, 8) | 0.90 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 | Proportion at Week 24 (n=115, 125) | 0.95 proportion of participants |
p-value: 0.38495% CI: [0.364, 1.479]Stratified Log-rank Test
Secondary
Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3
Kaplan-Meier estimated survival rate. Criteria for relapse include one or more of the following: relapse is defined as any of the following events accompanied by a Young-Mania Rating Scale (Y-MRS) \>16 and/or a Montgomery Åsberg Depression Rating Scale (MADRS) \>16; serious adverse event of worsening disease, or discontinuation by the investigator for lack of efficacy. A hospitalization for a manic, mixed, or depressive episode does meet the criteria for relapse, however does not require an accompanying Y-MRS and/or MADRS score \>16.
Time frame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3
Population: Randomized sample, n=number of participants at risk at given time point
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 0 (n=169,168) | 1.00 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 4 (n=153,148) | 0.99 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 8 (n=148,139) | 0.99 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 12 (n=142,133) | 0.97 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 16 (n=132,130) | 0.95 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 20 (n=122,128) | 0.93 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 24 (n=113,125) | 0.91 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 28 (n=105,121) | 0.90 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 32 (n=102,115) | 0.89 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 36 (n=99, 111) | 0.88 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 40 (n=95,110) | 0.87 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 44 (n=91,107) | 0.86 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 48 (n=88, 98) | 0.85 proportion of participants |
| Placebo | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 52 (n=5, 8) | 0.85 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 40 (n=95,110) | 0.95 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 0 (n=169,168) | 1.00 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 28 (n=105,121) | 0.97 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 4 (n=153,148) | 0.99 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 48 (n=88, 98) | 0.95 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 8 (n=148,139) | 0.98 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 32 (n=102,115) | 0.95 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 12 (n=142,133) | 0.97 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 44 (n=91,107) | 0.95 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 16 (n=132,130) | 0.97 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 36 (n=99, 111) | 0.95 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 20 (n=122,128) | 0.97 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 52 (n=5, 8) | 0.95 proportion of participants |
| Aripiprazole | Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 | Proportion at Week 24 (n=113,125) | 0.97 proportion of participants |
p-value: 0.01395% CI: [0.146, 0.829]Stratified Log-rank Test
Secondary
Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2
AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death).
Time frame: During Phase 2. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2 | Mild/Grade 1 | 172 Participants |
| Placebo | Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2 | Severe/Grade 3 | 20 Participants |
| Placebo | Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2 | Moderate/Grade 2 | 109 Participants |
| Placebo | Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2 | Very Severe/Grade 4 | 2 Participants |
| Placebo | Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2 | Any Adverse Event | 226 Participants |
| Aripiprazole | Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2 | Very Severe/Grade 4 | 1 Participants |
| Aripiprazole | Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2 | Any Adverse Event | 287 Participants |
| Aripiprazole | Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2 | Mild/Grade 1 | 219 Participants |
| Aripiprazole | Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2 | Moderate/Grade 2 | 165 Participants |
| Aripiprazole | Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2 | Severe/Grade 3 | 31 Participants |
Secondary
Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity
AE is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition. By Common Terminology Criteria Version 3.0 (CTC v3) Grade (Gr): Gr 1 (mild); Gr 2 (moderate); Gr 3 (severe); Gr 4 (life-threatening); Gr 5 (death).
Time frame: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
Population: Phase 3 Safety Sample; (n=number of participants in sample for each category)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Male Participants (n=70, 81) | 45 Participants |
| Placebo | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Non-White Participants (n=42, 31) | 42 Participants |
| Placebo | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Participants >50 Years (n=34, 36) | 24 Participants |
| Placebo | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Participants with Mild/Grade 1 AE | 75 Participants |
| Placebo | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Female Participants (n=96, 86) | 60 Participants |
| Placebo | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Participants with Moderate/Grade 2 AE | 53 Participants |
| Placebo | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Participants <= 50 Years (n=132, 131) | 81 Participants |
| Placebo | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Participants with Severe/Grade 3 AE | 11 Participants |
| Placebo | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Participants with Very Severe/Grade 4 AE | 1 Participants |
| Placebo | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | White Participants (n=63, 74) | 63 Participants |
| Aripiprazole | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Participants with Very Severe/Grade 4 AE | 2 Participants |
| Aripiprazole | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Participants <= 50 Years (n=132, 131) | 84 Participants |
| Aripiprazole | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Participants >50 Years (n=34, 36) | 21 Participants |
| Aripiprazole | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Male Participants (n=70, 81) | 47 Participants |
| Aripiprazole | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Female Participants (n=96, 86) | 58 Participants |
| Aripiprazole | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | White Participants (n=63, 74) | 74 Participants |
| Aripiprazole | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Non-White Participants (n=42, 31) | 31 Participants |
| Aripiprazole | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Participants with Mild/Grade 1 AE | 75 Participants |
| Aripiprazole | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Participants with Moderate/Grade 2 AE | 55 Participants |
| Aripiprazole | Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity | Participants with Severe/Grade 3 AE | 9 Participants |
Secondary
Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from baseline (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.
Time frame: Baseline (end of Ph 1), Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 4 (n=245, 326) | -1.73 units on a scale | Standard Error 0.075 |
| Placebo | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 12 (n=179, 252) | -2.60 units on a scale | Standard Error 0.081 |
| Placebo | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 2 (n=267, 354) | -1.15 units on a scale | Standard Error 0.064 |
| Placebo | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 16 (n=138, 193) | -2.83 units on a scale | Standard Error 0.086 |
| Placebo | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 6 (n=219, 305) | -2.04 units on a scale | Standard Error 0.081 |
| Placebo | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 20 (n=59, 99) | -2.93 units on a scale | Standard Error 0.162 |
| Placebo | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 1 (n=275, 370) | -0.58 units on a scale | Standard Error 0.047 |
| Placebo | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 24 (n=22, 39) | -2.91 units on a scale | Standard Error 0.185 |
| Placebo | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 8 (n=200, 287) | -2.40 units on a scale | Standard Error 0.076 |
| Placebo | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Phase 2 Endpoint(n=289,383) | -2.21 units on a scale | Standard Error 0.079 |
| Placebo | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Baseline (BL) (n=289, 383) | 4.22 units on a scale | Standard Error 0.04 |
| Aripiprazole | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Phase 2 Endpoint(n=289,383) | -2.01 units on a scale | Standard Error 0.066 |
| Aripiprazole | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Baseline (BL) (n=289, 383) | 4.06 units on a scale | Standard Error 0.035 |
| Aripiprazole | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 1 (n=275, 370) | -0.58 units on a scale | Standard Error 0.042 |
| Aripiprazole | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 2 (n=267, 354) | -1.06 units on a scale | Standard Error 0.055 |
| Aripiprazole | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 4 (n=245, 326) | -1.45 units on a scale | Standard Error 0.062 |
| Aripiprazole | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 6 (n=219, 305) | -1.82 units on a scale | Standard Error 0.065 |
| Aripiprazole | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 8 (n=200, 287) | -2.06 units on a scale | Standard Error 0.067 |
| Aripiprazole | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 12 (n=179, 252) | -2.27 units on a scale | Standard Error 0.071 |
| Aripiprazole | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 16 (n=138, 193) | -2.40 units on a scale | Standard Error 0.075 |
| Aripiprazole | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 20 (n=59, 99) | -2.32 units on a scale | Standard Error 0.115 |
| Aripiprazole | Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 | Mean Change from BL to Week 24 (n=22, 39) | -2.56 units on a scale | Standard Error 0.163 |
Secondary
Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from baseline (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.
Time frame: Baseline (end of Ph 1), Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 4 (n=245, 326) | -0.29 units on a scale | Standard Error 0.058 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 12 (n=179, 252) | -0.17 units on a scale | Standard Error 0.077 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 2 (n=267, 354) | -0.22 units on a scale | Standard Error 0.053 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 16 (n=138, 193) | -0.21 units on a scale | Standard Error 0.109 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 6 (n=219, 305) | -0.31 units on a scale | Standard Error 0.068 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 20 (n=59, 99) | -0.27 units on a scale | Standard Error 0.149 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 1 (n=275, 370) | -0.16 units on a scale | Standard Error 0.041 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 24 (n=22, 39) | -0.23 units on a scale | Standard Error 0.227 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 8 (n=200, 287) | -0.30 units on a scale | Standard Error 0.077 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Phase 2 Endpoint(n=289,383) | -0.16 units on a scale | Standard Error 0.069 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Baseline (BL) (n=289, 383) | 2.16 units on a scale | Standard Error 0.076 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Phase 2 Endpoint(n=289,383) | -0.26 units on a scale | Standard Error 0.063 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Baseline (BL) (n=289, 383) | 2.33 units on a scale | Standard Error 0.069 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 1 (n=275, 370) | -0.19 units on a scale | Standard Error 0.04 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 2 (n=267, 354) | -0.33 units on a scale | Standard Error 0.05 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 4 (n=245, 326) | -0.39 units on a scale | Standard Error 0.055 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 6 (n=219, 305) | -0.43 units on a scale | Standard Error 0.061 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 8 (n=200, 287) | -0.37 units on a scale | Standard Error 0.066 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 12 (n=179, 252) | -0.35 units on a scale | Standard Error 0.069 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 16 (n=138, 193) | -0.36 units on a scale | Standard Error 0.078 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 20 (n=59, 99) | -0.37 units on a scale | Standard Error 0.116 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 | Mean Change from BL to Week 24 (n=22, 39) | -0.46 units on a scale | Standard Error 0.217 |
Secondary
Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale \[1 to 7\], with 1 being normal and 7 being very severely ill). A negative change score signifies improvement.
Time frame: Baseline (end of Ph 1), Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 4 (n=245, 326) | -1.56 units on a scale | Standard Error 0.074 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 12 (n=179, 252) | -2.31 units on a scale | Standard Error 0.097 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 2 (n=267, 354) | -1.05 units on a scale | Standard Error 0.061 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 16 (n=138, 193) | -2.57 units on a scale | Standard Error 0.106 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 6 (n=219, 305) | -1.86 units on a scale | Standard Error 0.084 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 20 (n=59, 99) | -2.71 units on a scale | Standard Error 0.181 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 1 (n=275, 370) | -0.52 units on a scale | Standard Error 0.046 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 24 (n=22, 39) | -2.73 units on a scale | Standard Error 0.22 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 8 (n=200, 287) | -2.17 units on a scale | Standard Error 0.081 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Phase 2 Endpoint(n=289,383) | -1.90 units on a scale | Standard Error 0.085 |
| Placebo | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Baseline (BL) (n=289, 383) | 4.25 units on a scale | Standard Error 0.04 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Phase 2 Endpoint(n=289,383) | -1.66 units on a scale | Standard Error 0.07 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Baseline (BL) (n=289, 383) | 4.08 units on a scale | Standard Error 0.036 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 1 (n=275, 370) | -0.53 units on a scale | Standard Error 0.04 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 2 (n=267, 354) | -0.97 units on a scale | Standard Error 0.054 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 4 (n=245, 326) | -1.31 units on a scale | Standard Error 0.059 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 6 (n=219, 305) | -1.62 units on a scale | Standard Error 0.063 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 8 (n=200, 287) | -1.80 units on a scale | Standard Error 0.069 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 12 (n=179, 252) | -1.99 units on a scale | Standard Error 0.078 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 16 (n=138, 193) | -2.17 units on a scale | Standard Error 0.079 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 20 (n=59, 99) | -2.14 units on a scale | Standard Error 0.118 |
| Aripiprazole | Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 | Mean Change from BL to Week 24 (n=22, 39) | -2.38 units on a scale | Standard Error 0.186 |
Secondary
Unadjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) at Phase 2 Endpoint
The AIMS is an assessment of movement dysfunctions. It is a 12-item instrument assessing abnormal involuntary movements associated with antipsychotic drugs and 'spontaneous' motor disturbance related to the illness itself. Scoring the AIMS consists of rating the severity of movement in 3 main anatomic areas (facial/oral, extremities, and trunk), based on a five-point scale (0=none, 4=severe). The AIMS Total Score has a possible range from 0 to 28. Negative change scores indicate improvement in movement dysfunction.
Time frame: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample, participants with evaluation at time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Unadjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) at Phase 2 Endpoint | 0.05 units on a scale | Standard Error 0.056 |
| Aripiprazole | Unadjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) at Phase 2 Endpoint | 0.04 units on a scale | Standard Error 0.043 |
Secondary
Unadjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Phase 2 Endpoint
The Barnes Akathisia Rating Scale is a 4-item scale to assess presence and severity of drug-induced akathisia, including both objective items and subjective items, together with a global clinical assessment of akathisia. Global assessment is made on a scale of 0 to 5 with comprehensive definitions provided for each anchor point on scale: 0=absent; 1=questionable; 2=mild akathisia; 3=moderate akathisia; 4=marked akathisia; 5=severe akathisia. Score has a possible range from 0 (absent) to 5 (severe akathisia). Negative change scores indicate improvement in akathisia.
Time frame: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Unadjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Phase 2 Endpoint | 0.14 units on a scale | Standard Error 0.043 |
| Aripiprazole | Unadjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Phase 2 Endpoint | 0.07 units on a scale | Standard Error 0.039 |
Secondary
Unadjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score at Phase 2 Endpoint
The SAS is a 10-item instrument used to evaluate the presence and severity of parkinsonian symptomatology. It is the most commonly used rating scale for Parkinsonism in clinical trials over the past 25 years. The ten items focus on rigidity rather than bradykinesia, and do not assess subjective rigidity or slowness. Items are rated for severity on a 0-4 scale, with definitions given for each anchor point. The total SAS Score has a possible range from 10 to 50(lower score=less severe). Negative change scores indicate improvement.
Time frame: Baseline (end of Ph 1), Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Phase 2 Safety Sample, number of participants with evaluation at time point
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Unadjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score at Phase 2 Endpoint | 0.44 units on a scale | Standard Error 0.118 |
| Aripiprazole | Unadjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score at Phase 2 Endpoint | 0.15 units on a scale | Standard Error 0.073 |
Secondary
Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change in patients with bipolar disorder. Patients are rated on Change from Preceding Phase (mania, depression and overall bipolar illness) items (also a 7-point scale \[1 to 7\], with 1 being very much improved and 7 being very much worse).
Time frame: Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 1 (n=274, 368) | 3.56 units on a scale | Standard Error 0.054 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 2 (n=265, 353) | 3.42 units on a scale | Standard Error 0.061 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 4 (n=245, 325) | 3.35 units on a scale | Standard Error 0.074 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 6 (n=219, 305) | 3.22 units on a scale | Standard Error 0.083 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 8 (n=200, 287) | 3.13 units on a scale | Standard Error 0.09 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 12 (n=179, 250) | 3.28 units on a scale | Standard Error 0.094 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 16 (n=138, 193) | 3.30 units on a scale | Standard Error 0.117 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 20 (n=59, 99) | 3.24 units on a scale | Standard Error 0.173 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 24 (n=22, 39) | 2.91 units on a scale | Standard Error 0.278 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Phase 2 Endpoint(n=289,382) | 3.30 units on a scale | Standard Error 0.08 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 20 (n=59, 99) | 3.18 units on a scale | Standard Error 0.129 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 1 (n=274, 368) | 3.40 units on a scale | Standard Error 0.057 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 12 (n=179, 250) | 3.06 units on a scale | Standard Error 0.087 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 2 (n=265, 353) | 3.25 units on a scale | Standard Error 0.066 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Phase 2 Endpoint(n=289,382) | 3.26 units on a scale | Standard Error 0.075 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 4 (n=245, 325) | 3.19 units on a scale | Standard Error 0.071 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 16 (n=138, 193) | 2.99 units on a scale | Standard Error 0.1 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 6 (n=219, 305) | 3.13 units on a scale | Standard Error 0.078 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 24 (n=22, 39) | 3.15 units on a scale | Standard Error 0.251 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 | Mean Change from BL to Week 8 (n=200, 287) | 3.11 units on a scale | Standard Error 0.084 |
Secondary
Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline in patients with bipolar disorder. Patients are rated on mania, depression and overall change from preceding phase items on a 7-point scale \[1 to 7\], with 1 being very much improved and 7 being very much worse).
Time frame: Weeks 1, 2, 4,6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 1 (n=274, 369) | 3.15 units on a scale | Standard Error 0.055 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 2 (n=265, 353) | 2.61 units on a scale | Standard Error 0.062 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 4 (n=245, 325) | 2.14 units on a scale | Standard Error 0.06 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 6 (n=219, 305) | 1.95 units on a scale | Standard Error 0.065 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 8 (n=200, 287) | 1.73 units on a scale | Standard Error 0.062 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 12 (n=179, 252) | 1.66 units on a scale | Standard Error 0.074 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 16 (n=138, 193) | 1.54 units on a scale | Standard Error 0.082 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 20 (n=59, 99) | 1.69 units on a scale | Standard Error 0.161 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 24 (n=22, 39) | 1.64 units on a scale | Standard Error 0.214 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Phase 2 Endpoint(n=289,382) | 1.95 units on a scale | Standard Error 0.071 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 20 (n=59, 99) | 1.68 units on a scale | Standard Error 0.087 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 1 (n=274, 369) | 3.09 units on a scale | Standard Error 0.049 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 12 (n=179, 252) | 1.65 units on a scale | Standard Error 0.053 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 2 (n=265, 353) | 2.58 units on a scale | Standard Error 0.054 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Phase 2 Endpoint(n=289,382) | 1.94 units on a scale | Standard Error 0.056 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 4 (n=245, 325) | 2.24 units on a scale | Standard Error 0.056 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 16 (n=138, 193) | 1.61 units on a scale | Standard Error 0.056 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 6 (n=219, 305) | 1.97 units on a scale | Standard Error 0.056 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 24 (n=22, 39) | 1.67 units on a scale | Standard Error 0.181 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 | Mean Change from BL to Week 8 (n=200, 287) | 1.80 units on a scale | Standard Error 0.055 |
Secondary
Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2
Clinical Global Impression-Bipolar (CGI-BP) assesses global illness severity and change from baseline (in this case, preceding phase) in patients with bipolar disorder. Patients are rated on mania, depression and overall bipolar illness items on a 7-point scale \[1 to 7\], with 1 being very much improved and 7 being very much worse).
Time frame: Weeks 1, 2, 4, 6, 8, 12, 16, 20, 24, and Phase 2 Endpoint. Phase 2 (13- to 24-week Stability and Maintenance of Stability Phase, which followed a 2- to 8-week Screening, Washout, and Confirmation of Partial Nonresponse Phase)
Population: Observed Cases (OC) data set; phase 2 endpoint was phase 2 efficacy sample. n=number of participants with evaluation at time point
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 1 (n=274, 369) | 3.20 units on a scale | Standard Error 0.054 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 2 (n=265, 353) | 2.70 units on a scale | Standard Error 0.063 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 4 (n=245, 325) | 2.27 units on a scale | Standard Error 0.063 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 6 (n=219, 305) | 2.11 units on a scale | Standard Error 0.069 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 8 (n=200, 287) | 1.94 units on a scale | Standard Error 0.073 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 12 (n=179, 252) | 1.87 units on a scale | Standard Error 0.081 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 16 (n=138, 193) | 1.74 units on a scale | Standard Error 0.096 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 20 (n=59, 99) | 1.81 units on a scale | Standard Error 0.156 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 24 (n=22, 39) | 1.68 units on a scale | Standard Error 0.212 |
| Placebo | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Phase 2 Endpoint(n=289,382) | 2.26 units on a scale | Standard Error 0.082 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 20 (n=59, 99) | 1.90 units on a scale | Standard Error 0.112 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 1 (n=274, 369) | 3.13 units on a scale | Standard Error 0.048 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 12 (n=179, 252) | 1.94 units on a scale | Standard Error 0.071 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 2 (n=265, 353) | 2.69 units on a scale | Standard Error 0.057 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Phase 2 Endpoint(n=289,382) | 2.37 units on a scale | Standard Error 0.072 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 4 (n=245, 325) | 2.40 units on a scale | Standard Error 0.06 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 16 (n=138, 193) | 1.80 units on a scale | Standard Error 0.069 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 6 (n=219, 305) | 2.19 units on a scale | Standard Error 0.064 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 24 (n=22, 39) | 1.82 units on a scale | Standard Error 0.226 |
| Aripiprazole | Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 | Mean Change from BL to Week 8 (n=200, 287) | 2.08 units on a scale | Standard Error 0.07 |