Phase 4
N=1,270
A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00261443 ↗Enrolled (actual)
1,270
Serious AEs
3.2%
Results posted
Apr 2011
Primary outcome: Primary: Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 — 1.00; 1.00; 0.95; 0.96 proportion of participants — p=0.014
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Lithium or Valproate with placebo (PBO) (Drug); Lithium or Valproate with Aripiprazole (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Not Experiencing Relapse to Any Mood Episode Through Week 52, Phase 3 |
1.00; 1.00; 0.95; 0.96; 0.93; 0.94 | 0.014 sig |
| 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 |
1.54; 1.54; 0.01; 0.05; 0.05; 0.01 | 0.911 |
| SECONDARY Proportion of Participants Not Experiencing Relapse of Manic Episode Through Phase 3 |
1.00; 1.00; 0.99; 0.99; 0.99; 0.98 | 0.013 sig |
| SECONDARY Proportion of Participants Not Experiencing Relapse of Depressive Episode Through Week 52 During Phase 3 |
1.00; 1.00; 0.96; 0.98; 0.94; 0.97 | 0.384 |
| SECONDARY Mean Baseline and Unadjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 2 |
23.15; 22.32; -4.50; -4.86; -7.90; -7.82 | — |
| SECONDARY Mean Baseline and Adjusted Mean Change From Baseline in Young-Mania Rating Scale (Y-MRS) Total Score Through Phase 3 |
4.03; 4.06; 0.47; 0.53; 0.91; 0.23 | 0.955 |
| 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 |
10.97; 11.56; -1.48; -1.51; -2.23; -2.70 | — |
| SECONDARY Mean Baseline and Adjusted Mean Change From Baseline in Montgomery Åsberg Depression Rating Scale (MADRS) Total Score Through Phase 3 |
4.41; 4.62; 1.92; 1.42; 2.27; 1.23 | 0.590 |
| SECONDARY Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 2 |
4.25; 4.08; -0.52; -0.53; -1.05; -0.97 | — |
| SECONDARY Baseline and Adjusted Mean Change From Baseline in the CGI-BP Severity of Illness (Overall) Through Phase 3 |
1.65; 1.70; 0.25; 0.27; 0.32; 0.21 | 0.597 |
| SECONDARY Unadjusted Mean Change Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Depression) Through Phase 2 |
2.16; 2.33; -0.16; -0.19; -0.22; -0.33 | — |
| SECONDARY Baseline and Adjusted Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Score Through Phase 3 |
1.43; 1.47; 0.30; 0.29; 0.35; 0.24 | 0.588 |
| SECONDARY Unadjusted Mean Change From Preceding Phase in the CGI-BP (Mania) Through Phase 2 |
3.15; 3.09; 2.61; 2.58; 2.14; 2.24 | — |
| SECONDARY Unadjusted Mean Baseline and Mean Change From Baseline in the CGI-BP Severity of Illness (Mania) Through Phase 2 |
4.22; 4.06; -0.58; -0.58; -1.15; -1.06 | — |
| SECONDARY Adjusted Mean Change in CGI-BP From Preceding Phase (Mania) Through Phase 3 |
2.96; 3.00; 3.17; 2.98; 3.14; 3.03 | 0.774 |
| SECONDARY Unadjusted Mean Change From Preceding Phase in the CGI-BP (Depression) Through Phase 2 |
3.56; 3.40; 3.42; 3.25; 3.35; 3.19 | — |
| SECONDARY Adjusted Mean Change in CGI-BP From Preceding Phase (Depression) Through Phase 3 |
3.46; 3.56; 3.55; 3.52; 3.51; 3.45 | 0.486 |
| SECONDARY Unadjusted Mean Change From Preceding Phase in the CGI-BP (Overall) Through Phase 2 |
3.20; 3.13; 2.70; 2.69; 2.27; 2.40 | — |
| SECONDARY Adjusted Mean Change in CGI-BP From Preceding Phase (Overall) Through Phase 3 |
3.17; 3.27; 3.36; 3.22; 3.34; 3.27 | 0.488 |
| SECONDARY Number of Participants Maintaining Remission During Phase 3 |
142; 142; 138; 136; 133; 126 | 0.910 |
| SECONDARY Proportion of Participants Discontinuing For Any Reason Through Week 52 (During Phase 3) |
0.473; 0.387 | 0.132 |
| SECONDARY Deaths, Serious Adverse Events (SAEs), Adverse Events (AEs), and Discontinuations Due to AEs During Phase 2 |
0; 0; 5; 10; 38; 50 | — |
| SECONDARY Treatment-Emergent Adverse Events in >=5 Percent of Participants, by Severity, During Phase 2 |
226; 287; 172; 219; 109; 165 | — |
| SECONDARY Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 2 |
0; 2; 0; 4; 0; 2 | — |
| SECONDARY Number of Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 2 |
2; 4; 0; 4; 1; 6 | — |
| SECONDARY Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 2 |
0; 0; 3; 6; 0; 3 | — |
| SECONDARY Median Baseline and Change From Baseline in ECG Measurements During Phase 2 |
415.0; 412.0; 4.0; -8.0; 403.0; 400.0 | — |
| SECONDARY Median Baseline and Change From Baseline in Heart Rate Vital Sign Measurements During Phase 2 |
76.0; 74.0; 0.0; 0.0; 78.0; 82.0 | — |
| SECONDARY Median Baseline and Change From Baseline in Blood Pressure (BP) Vital Sign Measurements During Phase 2 |
120.0; 120.0; 0.0; 0.0; 76.0; 77.5 | — |
| SECONDARY Median Baseline and Change From Baseline in Weight Vital Sign Measurements At Phase 2 Endpoint |
76.2; 76.4; 0.9; 1.5 | — |
| SECONDARY Median Baseline and Change From Baseline in Body Mass Index (BMI) Vital Sign Measurements at Phase 2 Endpoint |
26.9; 27.2; 0.3; 0.5 | — |
| SECONDARY Median Baseline Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase (CK), and Lactate Dehydrogenase (LD), Phase 2 Safety Sample |
72.0; 64.0; 20.0; 17.0; 19.0; 20.0 | — |
| 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 |
-2.0; -2.0; 0.0; 2.0; 0.0; 1.0 | — |
| SECONDARY Median Baseline and Change From Baseline in Heart Rate Measurements During Phase 2 |
71.0; 69.0; 0.0; 0 | — |
| 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 |
11.0; 13.0; 182.0; 174.0; 0.900; 0.900 | — |
| 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 |
0.0; 0.0; -1.0; 4.5; 0.0; 0.0 | — |
| SECONDARY Median Baseline Eosinophils (Relative) and Neutrophils (Relative) |
2.50; 2.20; 67.60; 58.10 | — |
| SECONDARY Median Change From Baseline in Eosinophils (Relative) and Neutrophils (Relative) |
-0.40; -0.20; 0.25; 0.60 | — |
| SECONDARY Median Baseline Hemoglobin |
13.75; 13.80 | — |
| SECONDARY Median Change From Baseline in Hemoglobin |
0.05; 0.10 | — |
| SECONDARY Median Baseline Hematocrit |
41.30; 41.10 | — |
| SECONDARY Median Change From Baseline in Hematocrit |
0.30; 0.20 | — |
| SECONDARY Median Baseline Homeostasis Model Assessment 2 (HOMA2)-Percent Beta |
99.95; 118.70 | — |
| SECONDARY Median Baseline Homeostasis Model Assessment 2 HOMA2-Insulin Resistance (IR) |
1.14; 1.42 | — |
| SECONDARY Median Change From Baseline in Homeostasis Model Assessment 2(HOMA2)-Percent Beta at Phase 2 Endpoint |
7.70; 17.05 | — |
| SECONDARY Median Change From Baseline in HOMA2 Model Assesses Insulin Resistance (HOMA2-IR) at Phase 2 Endpoint |
0.09; 0.15 | — |
| SECONDARY Median Baseline Platelet Count |
297.0; 226.0 | — |
| SECONDARY Median Change From Baseline in Platelet Count at Phase 2 Endpoint |
-4.0; -2.0 | — |
| SECONDARY Median Baseline Prolactin |
10.0; 9.5 | — |
| SECONDARY Median Change From Baseline in Prolactin at Phase 2 Endpoint |
-2.5; -3.0 | — |
| SECONDARY Median Baseline Leukocytes |
8.350; 6.800 | — |
| SECONDARY Median Change From Baseline in Leukocytes at Phase 2 Endpoint |
-0.100; -0.200 | — |
| SECONDARY Baseline Abnormal Involuntary Movement Scale (AIMS) |
0.10; 0.08 | — |
| SECONDARY Unadjusted Mean Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) at Phase 2 Endpoint |
0.05; 0.04 | — |
| SECONDARY Baseline in Simpson-Angus Scale (SAS) Total Score |
10.28; 10.30 | — |
| SECONDARY Unadjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score at Phase 2 Endpoint |
0.44; 0.15 | — |
| SECONDARY Baseline in Barnes Akathisia Global Clinical Assessment |
0.09; 0.14 | — |
| SECONDARY Unadjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment at Phase 2 Endpoint |
0.14; 0.07 | — |
| SECONDARY Deaths, Treatment-Emergent Serious Adverse Events (SAEs), Adverse Events (AEs) in >=2% of Participants, and AEs Leading to Discontinuation During Phase 3 |
1; 1; 8; 11; 105; 105 | — |
| SECONDARY Treatment-Emergent AEs in >=5% of Participants During Phase 3, by Age, Gender, Race, and Maximum Intensity |
81; 84; 24; 21; 45; 47 | — |
| SECONDARY Participants With Potentially Clinically Relevant Vital Sign Abnormalities During Phase 3 |
0; 0; 2; 1; 0; 0 | — |
| SECONDARY Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Systolic BP During Phase 3 |
120.0; 120.0; 0.0; 0.0; 8.0; 6.0 | 0.640 |
| SECONDARY Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Diastolic BP During Phase 3 |
78.0; 79.0; 0.0; 0.0; 5.5; 6.0 | 0.656 |
| SECONDARY Median Baseline, Change From Baseline, and Highest and Lowest Values in Supine Heart Rate During Phase 3 |
74.0; 74.0; 0.0; 1.0; 7.5; 8.0 | 0.619 |
| SECONDARY Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Systolic BP During Phase 3 |
120.0; 120.0; 2.0; 0.0; 8.0; 4.0 | 0.184 |
| SECONDARY Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Diastolic BP During Phase 3 |
80.0; 80.0; 0.0; -2.0; 4.0; 0.0 | 0.142 |
| SECONDARY Median Baseline, Change From Baseline, and Highest and Lowest Values in Sitting Heart Rate During Phase 3 |
78.0; 76.0; -4.0; -2.0; 3.0; 4.0 | 0.916 |
| SECONDARY Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Systolic BP During Phase 3 |
120.0; 120.0; 0.0; 0.0; 8.0; 6.0 | 0.871 |
| SECONDARY Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Diastolic BP During Phase 3 |
78.0; 78.0; 0.0; 0.0; 6.0; 6.0 | 0.935 |
| SECONDARY Median Baseline, Change From Baseline, and Highest and Lowest Values in Standing Heart Rate During Phase 3 |
78.0; 78.0; 0.0; 1.0; 6.0; 7.0 | 0.850 |
| SECONDARY Baseline and Adjusted Mean Change From Baseline in Weight |
81.33; 80.22; -1.00; 0.28; 0.35; 0.13 | 0.491 |
| SECONDARY Number of Participants Showing Relevant Weight Gain During Phase 3 |
3; 6; 6; 11; 16; 12 | 0.279 |
| SECONDARY Number of Participants Showing Relevant Weight Loss During Phase 3 |
5; 6; 7; 8; 7; 8 | 0.685 |
| SECONDARY Median Baseline and Change From Baseline in Body Mass Index (BMI) During Phase 3 |
27.0; 27.9; 0.0; 0.2; 0.1; 0.2 | 0.646 |
| SECONDARY Number of Participants With Potentially Clinically Relevant Laboratory Abnormalities During Phase 3 |
2; 0; 3; 3; 0; 0 | — |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in Alkaline Phosphatase (ALP), Phase 3 Safety Sample |
60.5; 62.5; 1.0; 0.0; 8.0; 7.0 | 0.331 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in ALT, Phase 3 Safety Sample |
19.5; 20.0; -1.0; 0.0; 6.0; 5.0 | 0.111 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in AST, Phase 3 Safety Sample |
20.0; 22.0; 1.0; -1.0; 5.0; 6.0 | 0.077 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in BUN, Phase 3 Safety Sample |
11.0; 12.0; 0.0; 0.0; 3.0; 2.0 | 0.118 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in Total Cholesterol (Fasting), Phase 3 Safety Sample |
180.0; 181.0; 5.0; -0.5; 18.5; 20.5 | 0.878 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in Creatine Kinase, Phase 3 Safety Sample |
82.0; 91.5; 5.0; -2.0; 33.0; 28.0 | 0.043 sig |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in Creatinine, Phase 3 Safety Sample |
0.900; 0.900; 0.000; 0.000; 0.100; 0.100 | 0.105 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in Eosinophils (Relative), Phase 3 Safety Sample |
2.30; 2.20; 0.00; -0.10; 0.80; 0.90 | 0.507 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in Glucose (Fasting), Phase 3 Safety Sample |
90.0; 90.0; 0.0; 0.0; 6.0; 7.0 | 0.741 |
| SECONDARY Median Baseline, Change From Baseline, and Lowest Value of Change in Hemoglobin, Phase 3 Safety Sample |
13.80; 14.00; -0.10; -0.10; -0.50; -0.60 | 0.080 |
| SECONDARY Median Baseline, Change From Baseline, and Lowest Value of Change in Hematocrit, Phase 3 Safety Sample |
41.40; 42.15; -0.40; -0.30; -1.60; -1.90 | 0.187 |
| SECONDARY Median Baseline, Change From Baseline, and Lowest Value of Change in HDL Cholesterol (Fasting), Phase 3 Safety Sample |
46.0; 45.0; -1.0; -1.0; -5.0; -5.0 | 0.180 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-Percent Beta, Phase 3 Safety Sample |
120.0; 106.90; -6.35; 8.50; -10.85; 5.30 | 0.349 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in HOMA2-IR, Phase 3 Safety Sample |
1.24; 1.06; -0.13; -0.13; 0.20; 0.37 | 0.550 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in Lactate Dehydrogenase, Phase 3 Safety Sample |
161.0; 171.0; 4.0; 0.0; 25.0; 19.0 | 0.004 sig |
| SECONDARY Median Baseline, Change From Baseline, and Highest Change Value in LDL Cholesterol (Fasting), Phase 3 Safety Sample |
104.5; 100.0; 3.5; 0.0; 16.0; 16.5 | 0.808 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in Neutrophils (Relative), Phase 3 Safety Sample |
61.55; 62.60; -1.30; -0.55; -6.45; -6.20 | 0.967 |
| SECONDARY Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Platelet Count, Phase 3 Safety Sample |
252.0; 254.0; -1.0; -3.5; 26.0; 17.5 | 0.663 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in Prolactin, Phase 3 Safety Sample |
7.0; 6.0; 2.0; 0.0; 3.0; 1.0 | 0.412 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in Total Bilirubin, Phase 3 Safety Sample |
0.40; 0.40; 0.00; 0.00; 0.10; 0.10 | 0.630 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in Triglycerides (Fasting), Phase 3 Safety Sample |
130.0; 134.5; 4.0; 0.0; 37.0; 42.0 | 0.273 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in Uric Acid, Phase 3 Safety Sample |
5.50; 5.75; -0.10; 0.00; 0.65; 0.50 | 0.189 |
| SECONDARY Median Baseline, Change From Baseline, and Highest and Lowest Value of Change in Leukocytes, Phase 3 Safety Sample |
6.900; 7.650; 0.150; -0.100; 1.100; 1.100 | 0.124 |
| SECONDARY Number of Participants With Potentially Clinically Relevant Electrocardiogram (ECG) Abnormalities During Phase 3 |
1; 0; 1; 1; 1; 0 | — |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in QT Interval Corrected for Heart Rate (QTc) Bazett, Phase 3 Safety Sample |
415.0; 410.0; 3.0; 3.0; 6.0; 12.0 | 0.213 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in QTc (0.33), Phase 3 Safety Sample |
404.0; 400.0; 1.0; 2.0; 3.0; 10.0 | 0.205 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in PR, Phase 3 Safety Sample |
155.0; 150.0; -2.0; 0.0; 2.0; 4.0 | 0.012 sig |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in RR, Phase 3 Safety Sample |
857.0; 870.0; 3.0; -4.0; 38.0; 20.0 | 0.571 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in QRS, Phase 3 Safety Sample |
89.0; 90.0; 0.0; 0.0; 2.0; 2.0 | 0.826 |
| SECONDARY Adjusted Mean Change From Baseline in Simpson-Angus Scale (SAS) Total Score During Phase 3 |
10.48; 10.50; -0.02; 0.04; -0.13; -0.03 | 0.235 |
| SECONDARY Median Baseline, Change From Baseline, and Highest Value of Change in Heart Rate, Phase 3 Safety Sample |
70.0; 69.0; 0.0; 0.0; 1.0; 3.0 | 0.587 |
| SECONDARY Adjusted Mean Change From Baseline in AIMS Total Score During Phase 3 |
0.11; 0.14; -0.01; 0.05; 0.11; 0.11 | 0.514 |
| SECONDARY Adjusted Mean Change From Baseline in AIMS Item 8 During Phase 3 |
0.04; 0.03; -0.01; 0.03; 0.01; 0.02 | 0.904 |
| SECONDARY Adjusted Mean Change From Baseline in AIMS Item 9 During Phase 3 |
0.01; 0.01; -0.01; 0.01; 0.03; 0.02 | 0.808 |
| SECONDARY Adjusted Mean Change From Baseline in AIMS Item 10 During Phase 3 |
0.02; 0.04; -0.00; 0.03; 0.02; 0.01 | 0.576 |
| SECONDARY Adjusted Mean Change From Baseline in Barnes Akathisia Global Clinical Assessment During Phase 3 |
0.10; 0.16; -0.01; 0.01; -0.06; -0.04 | 0.774 |
| SECONDARY Number of Participants Taking Concomitant Medications for Potential Treatment of Extrapyramidal Syndrome (EPS) During Phase 3 |
36; 40; 18; 21; 10; 19 | — |
| SECONDARY Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP (Mania) |
1.26; 1.35; -0.26; -0.30; -0.28; -0.30 | — |
| SECONDARY Extension Phase: Mean Change From Baseline in CGI-BP (Mania) Severity of Illness at Extension Phase Endpoint |
-0.05; -0.35 | — |
| SECONDARY Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Depression) at Extension Phase Endpoint |
-0.16; 0.00 | — |
| SECONDARY Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Depression) Through Extension Phase |
1.21; 1.00; -0.11; 0.00; -0.11; 0.00 | — |
| SECONDARY Extension Phase: Mean Baseline and Mean Change From Baseline in CGI-BP Severity of Illness (Overall) Through Extension Phase |
1.37; 1.35; -0.26; -0.30; -0.28; -0.30 | — |
| SECONDARY Extension Phase: Mean Change From Baseline in CGI-BP Severity of Illness (Overall) at Extension Phase Endpoint |
-0.11; -0.35 | — |
| SECONDARY Extension Phase: Deaths, Adverse Events (AES), Serious Adverse Events (SAEs), and Discontinuations |
0; 0; 0; 0; 5; 8 | — |
| SECONDARY Extension Phase: Participants With Potentially Clinically Relevant Metabolic Laboratory Abnormalities During Extension Phase |
0; 0; 2; 3; 12; 11 | — |
| SECONDARY Extension Phase: Participants With Potentially Clinically Relevant Vital Sign Abnormalities |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Extension Phase: Adverse Events (AEs), by Maximum Intensity |
4; 7; 1; 2; 0; 0 | — |
| SECONDARY Extension Phase: Participants With Potentially Clinically Relevant Laboratory Abnormalities |
1; 0; 2; 0; 2; 0 | — |
| SECONDARY Extension Phase: Participants With Potentially Clinically Relevant ECG Abnormalities |
4; 1; 1; 3; 1; 1 | — |
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.
Data sourced from ClinicalTrials.gov (NCT00261443). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.