drugset / Trial / NCT03257865
A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder
Phase 3
Completed
333 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
To demonstrate the efficacy of brexpiprazole for the acute treatment of manic episodes, with or without mixed features, in participants with a diagnosis of bipolar I disorder.
Timeline
- Start
- 2017-09-19
- Primary completion
- 2019-01-22
- Completion
- 2019-01-22
Outcome
Missed primary endpoint
registry analysis (superiority test); Brexpiprazole vs Placebo; p =0.1011; Treatment difference -1.62 (95% CI -3.56 to 0.32); mixed-effect model repeated measure NCT03257865 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brexpiprazole | Small molecule | 3 mg | Oral |