Clinical Trial Evaluating the Efficacy, Safety, and Tolerability of Cariprazine in a Dose-Reduction Paradigm in the Prevention of Relapse in Participants With Schizophrenia
Summary
1. To evaluate the efficacy and safety of cariprazine at a target dose of 4.5 milligram per day (mg/d) compared with placebo in prevention of relapse in patients with schizophrenia 2. To evaluate the efficacy and safety of cariprazine at a target dose of 3.0 mg/d compared with placebo in prevention of relapse in patients with schizophrenia who were initially stabilized on a target dose of 4.5 mg/d
Timeline
- Start
- 2018-07-30
- Primary completion
- 2021-02-11
- Completion
- 2021-02-11
Outcome
Missed primary endpoint
Stopped: “FDA Released Allergan from this post marketing requirement”
registry analysis (superiority test); Placebo (Double-blind Treatment Period) vs Cariprazine 3.0 mg/Day (Double-blind Treatment Period); p =0.1576; Hazard Ratio (HR) 0.56 (95% CI 0.25 to 1.29); Log Rank; NCT03593213 ↗
registry analysis (superiority test); Placebo (Double-blind Treatment Period) vs Cariprazine 4.5 mg/Day (Double-blind Treatment Period); p =0.2066; Hazard Ratio (HR) 0.61 (95% CI 0.26 to 1.45); Log Rank; NCT03593213 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cariprazine | Small molecule | 3 mg | Oral |
| Subject | Cariprazine | Small molecule | 4.5 mg | Oral |