Clinical trial NCT00261443: A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania
Official title: Efficacy of Aripiprazole in Combination With Lithium or Valproate in the Long-Term Maintenance Treatment of Bipolar I Disorder in Outpatients Partially Nonresponsive to Lithium or Valproate Monotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: Bipolar I Disorder with a recent manic or mixed episode
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2005-12-05
Enrollment: 1270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3
timeFrame: 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])
Secondary outcomes:
measure: 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
timeFrame: Baseline (end of Phase 2), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52
measure: Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3
timeFrame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3
measure: Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3
timeFrame: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 of phase 3
measure: Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2
timeFrame: 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)
measure: Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3
timeFrame: 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])
measure: 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
timeFrame: 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)
measure: Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3
timeFrame: 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])
measure: Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2
timeFrame: 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)
measure: Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3
timeFrame: 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])
measure: Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2
timeFrame: 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)
measure: Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3
timeFrame: 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])
measure: Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2
timeFrame: 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)
measure: Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2
timeFrame: 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)
measure: Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3
timeFrame: 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])
measure: Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2
timeFrame: 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)
measure: Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3
timeFrame: 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])
measure: Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2
timeFrame: 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)
measure: Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3
timeFrame: 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])
measure: Number of Participants Maintaining Remission During Phase 3
timeFrame: 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])
measure: Proportion of Participants Discontinuing For Any Reason Through Week 52 (During Phase 3)
timeFrame: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
measure: Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2
timeFrame: 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)
measure: Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2
timeFrame: 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)
measure: Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2
timeFrame: 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)
measure: Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2
timeFrame: 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)
measure: Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2
timeFrame: 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)
measure: Median Baseline and Change From Baseline in ECG Measurements During Phase 2
timeFrame: 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)
measure: Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2
timeFrame: 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)
measure: Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2
timeFrame: 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)
measure: Median Baseline and Change From Baseline in Weight Vital Sign Measurements At Phase 2 Endpoint
timeFrame: 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)
measure: Median Baseline and Change From Baseline in Body Mass Index (BMI) Vital Sign Measurements at Phase 2 Endpoint
timeFrame: 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)
measure: Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample
timeFrame: Baseline
measure: 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
timeFrame: 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)
measure: Median Baseline and Change From Baseline in Heart Rate Measurements During Phase 2
timeFrame: 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)
measure: 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
timeFrame: Baseline
measure: 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
timeFrame: 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)
measure: Median Baseline Eosinophils (Relative) and Neutrophils (Relative)
timeFrame: Baseline
measure: Median Change From Baseline in Eosinophils (Relative) and Neutrophils (Relative)
timeFrame: 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)
measure: Median Baseline Hemoglobin
timeFrame: Baseline
measure: Median Change From Baseline in Hemoglobin
timeFrame: 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)
measure: Median Baseline Hematocrit
timeFrame: Baseline
measure: Median Change From Baseline in Hematocrit
timeFrame: 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)
measure: Median Baseline Homeostasis Model Assessment 2 (HOMA2)-Percent Beta
timeFrame: Baseline
measure: Median Baseline Homeostasis Model Assessment 2 HOMA2-Insulin Resistance (IR)
timeFrame: Baseline
measure: Median Change From Baseline in Homeostasis Model Assessment 2(HOMA2)-Percent Beta at Phase 2 Endpoint
timeFrame: 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)
measure: Median Change From Baseline in HOMA2 Model Assesses Insulin Resistance (HOMA2-IR) at Phase 2 Endpoint
timeFrame: 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)
measure: Median Baseline Platelet Count
timeFrame: Baseline
measure: Median Change From Baseline in Platelet Count at Phase 2 Endpoint
timeFrame: 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)
measure: Median Baseline Prolactin
timeFrame: Baseline
measure: Median Change From Baseline in Prolactin at Phase 2 Endpoint
timeFrame: 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)
measure: Median Baseline Leukocytes
timeFrame: Baseline
measure: Median Change From Baseline in Leukocytes at Phase 2 Endpoint
timeFrame: 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)
measure: Baseline Abnormal Involuntary Movement Scale (AIMS)
timeFrame: Baseline
measure: Unadjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) at Phase 2 Endpoint
timeFrame: 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)
measure: Baseline in Simpson-Angus Scale (SAS) Total Score
timeFrame: Baseline
measure: Unadjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score at Phase 2 Endpoint
timeFrame: 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)
measure: Baseline in Barnes Akathisia Global Clinical Assessment
timeFrame: Baseline
measure: Unadjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Phase 2 Endpoint
timeFrame: 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)
measure: Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3
timeFrame: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
measure: Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity
timeFrame: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
measure: Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3
timeFrame: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
measure: Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3
timeFrame: Baseline, During Phase 3 (for highest/lowest values), Week 52
measure: Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3
timeFrame: Baseline, During Phase 3 (for highest/lowest values), Week 52
measure: Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3
timeFrame: Baseline, During Phase 3 (for highest/lowest values), Week 52
measure: Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3
timeFrame: Baseline, During Phase 3 (for highest/lowest values), Week 52
measure: Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3
timeFrame: Baseline, During Phase 3 (for highest/lowest values), Week 52
measure: Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3
timeFrame: Baseline, During Phase 3 (for highest/lowest values), Week 52
measure: Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3
timeFrame: Baseline, During Phase 3 (for highest/lowest values), Week 52
measure: Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3
timeFrame: Baseline, During Phase 3 (for highest/lowest values), Week 52
measure: Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3
timeFrame: Baseline, During Phase 3 (for highest/lowest values), Week 52
measure: Baseline and Adjusted Mean Change From Baseline in Weight
timeFrame: Baseline, Weeks 12, 24, 36, 52, During Phase 3 (for highest value)
measure: Number of Participants Showing Relevant Weight Gain During Phase 3
timeFrame: Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment)
measure: Number of Participants Showing Relevant Weight Loss During Phase 3
timeFrame: Weeks 12, 24, 36, 52, 52 (LOCF), and throughout Phase 3 (for 'at any time' assessment)
measure: Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3
timeFrame: Baseline, Week 12, Week 24, Week 36, Week 52, Week 52 (LOCF), During Phase 3 (for lowest/highest values)
measure: Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3
timeFrame: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
measure: Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value)
measure: Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value)
measure: Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for lowest value
measure: Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value
measure: Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value
measure: Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest/lowest value)
measure: Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3
timeFrame: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
measure: Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3
timeFrame: Baseline, Weeks 4,8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)
measure: Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample
timeFrame: Baseline, Week 52 (LOCF), Throughout Phase 3 (for highest value)
measure: Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)
measure: Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)
measure: Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)
measure: Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)
measure: Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3
timeFrame: Baseline, Weeks 4, 8, 12, 24, 36, 52, throughout Phase 3 (for Highest Value of Change)
measure: Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3
timeFrame: Phase 3 (A 52-Week Assessment of Relapse Phase following Phase 2 [13 to 24 weeks] and Phase 1 [2 to 8 weeks])
measure: Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania)
timeFrame: 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])
measure: Extension Phase: Mean Change From Baseline in CGI-BP (Mania) Severity of Illness at Extension Phase Endpoint
timeFrame: 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])
measure: Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Depression) at Extension Phase Endpoint
timeFrame: 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])
measure: Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase
timeFrame: 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])
measure: Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase
timeFrame: 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])
measure: Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Overall) at Extension Phase Endpoint
timeFrame: 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])
measure: Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations
timeFrame: 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])
measure: Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase
timeFrame: 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])
measure: Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities
timeFrame: 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])
measure: Extension Phase: Adverse Events (AEs), by Maximum Intensity
timeFrame: 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])
measure: Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities
timeFrame: 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])
measure: Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities
timeFrame: 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])
Other outcomes:
Locations:
city: Tuscaloosa
country: United States
facility: Tuscaloosa Va Medical Center
state: Alabama
city: Anaheim
country: United States
facility: Pravin Kansagra, M.D.
state: California
city: Cerritos
country: United States
facility: Psychopharmacology Research Network Of Torrance
state: California
city: Costa Mesa
country: United States
facility: Atp Clinical Research, Inc.
state: California
city: Costa Mesa
country: United States
facility: Us Clinical Research Centers, Llc
state: California
city: Long Beach
country: United States
facility: Va Long Beach Healthcare System
state: California
city: National City
country: United States
facility: Synergy Clinical Research Center
state: California
city: Orange
country: United States
facility: University Of California, Irvine Medical Center
state: California
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Tampa
country: United States
facility: University Of South Florida
state: Florida
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Worcester
country: United States
facility: University Of Massachusetts Medical School
state: Massachusetts
city: Saint Louis
country: United States
facility: Psych Care Consultants Research
state: Missouri
city: Clementon
country: United States
facility: Cns Research Institute, P.C.
state: New Jersey
city: New York
country: United States
facility: Neuropsychiatric Research Associates
state: New York
city: Staten Island
country: United States
facility: Behavioral Medical Research Of Staten Island
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Raleigh
country: United States
facility: Psychiatry And Clinical Research
state: North Carolina
city: Beachwood
country: United States
facility: Rakesh Ranjan, Md & Associates, Inc.
state: Ohio
city: Cincinnati
country: United States
facility: University Of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Metro Health Medical Center
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Portland
country: United States
facility: Portland Va Medical Center
state: Oregon
city: Austin
country: United States
facility: Senior Adults Specialty Research, Inc.
state: Texas
city: Dallas
country: United States
facility: Futuresearch Trials
state: Texas
city: DeSoto
country: United States
facility: Insite Clinical Research
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, Pa
state: Texas
city: Salt Lake City
country: United States
facility: University Of Utah School Of Medicine
state: Utah
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Salvador
country: Brazil
facility: Local Institution
state: Bahia
city: Aparecida De Goinia
country: Brazil
facility: Local Institution
state: Goias
city: Pelotas
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Bourgas
country: Bulgaria
facility: Local Institution
city: Rousse
country: Bulgaria
facility: Local Institution
city: Rijeka
country: Croatia
facility: Local Institution
city: Split
country: Croatia
facility: Local Institution
city: Zadar
country: Croatia
facility: Local Institution
city: Zagreb
country: Croatia
facility: Local Institution
city: Brno
country: Czechia
facility: Local Institution
city: Brno
country: Czechia
facility: Local Institution
city: Havirov
country: Czechia
facility: Local Institution
city: Litomerice
country: Czechia
facility: Local Institution
city: Prague 2
country: Czechia
facility: Local Institution
city: Praha 6
country: Czechia
facility: Local Institution
city: Prerov
country: Czechia
facility: Local Institution
city: Nantes
country: France
facility: Local Institution
state: Cedex 01
city: Dole
country: France
facility: Local Institution
city: Henin Beaumont
country: France
facility: Local Institution
city: Jonzac Cedex
country: France
facility: Local Institution
city: La Seyne Sur Mer
country: France
facility: Local Institution
city: Marseille
country: France
facility: Local Institution
city: Nantes
country: France
facility: Local Institution
city: Nimes
country: France
facility: Local Institution
city: Rennes
country: France
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Local Institution
state: Gujarat
city: Ahmedabad
country: India
facility: Local Institution
state: Gujarat
city: Kalyan (West)
country: India
facility: Local Institution
state: Maharashtra
city: Nagur
country: India
facility: Local Institution
state: Maharashtra
city: Pune
country: India
facility: Local Institution
state: Maharashtra
city: Mangalore
country: India
facility: Local Institution
state: Manipal
city: Mumbai
country: India
facility: Local Institution
state: Sion (W)
city: Delhi
country: India
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
city: Mumbai
country: India
facility: Local Institution
city: Mumbai
country: India
facility: Local Institution
city: New Delhi
country: India
facility: Local Institution
city: New Delhi
country: India
facility: Local Institution
city: Izhevsk
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Nizhny Novgorod
country: Russian Federation
facility: Local Institution
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution
city: Saratov
country: Russian Federation
facility: Local Institution
city: St-Petersburg
country: Russian Federation
facility: Local Institution
city: Tomsk
country: Russian Federation
facility: Local Institution
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Berea
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Durban
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Cape Town
country: South Africa
facility: Local Institution
state: Western Cape
city: Paarl
country: South Africa
facility: Local Institution
state: Western Cape
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Marcus R, Khan A, Rollin L, Morris B, Timko K, Carson W, Sanchez R. Efficacy of aripiprazole adjunctive to lithium or valproate in the long-term treatment of patients with bipolar I disorder with an inadequate response to lithium or valproate monotherapy: a multicenter, double-blind, randomized study. Bipolar Disord. 2011 Mar;13(2):133-44. doi: 10.1111/j.1399-5618.2011.00898.x.