A Cariprazine Study in the Prevention of Relapse in Bipolar I Disorder Patients Whose Current Episode is Manic or Depressive, With or Without Mixed Features
Summary
1\) To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features; 2) To evaluate the efficacy and safety of cariprazine at a target dose of 1.5 mg/day compared with placebo in prevention of relapse in patients with bipolar I disorder whose current episode (i.e. index episode) is manic or depressive, with or without mixed features who were initially stabilized on a target dose of 3.0 mg/day
Timeline
- Start
- 2018-06-15
- Primary completion
- 2022-09-05
- Completion
- 2022-09-05
Outcome
Missed primary endpoint
registry analysis (superiority test); Double-Blind Placebo QD vs Double-Blind Cariprazine 1.5 mg QD; p = 0.5745; Hazard Ratio (HR) 0.83 (95% CI 0.48 to 1.43); Log Rank; NCT03573297 ↗
registry analysis (superiority test); Double-Blind Placebo QD vs Double-Blind Cariprazine 3.0 mg QD; p = 0.6308; Hazard Ratio (HR) 0.89 (95% CI 0.52 to 1.51); Log Rank; NCT03573297 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cariprazine | Small molecule | 1.5 mg | Oral |
| Subject | Cariprazine | Small molecule | 3 mg | Oral |