Phase 4
Completed N=1,270
A Study of Aripiprazole (Abilify) in Patients With Bipolar Mania
Source: ClinicalTrials.gov NCT00261443 ↗Enrolled (actual)
1,270
Serious AEs
3.2%
Results posted
Apr 2011
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.