drugset / Trial / NCT03259555
A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder
Phase 3
Completed
322 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
- 2017-09-14
- Primary completion
- 2019-01-02
- Completion
- 2019-01-02
Outcome
Missed primary endpoint
registry analysis (superiority test); Brexpiprazole vs Placebo; p =0.8797; Treatment difference 0.14 (95% CI -1.74 to 2.03) NCT03259555 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brexpiprazole | Small molecule | 3 mg | Oral |