drugset / Trial / NCT03287869
A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
Phase 3
Completed
381 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
H. Lundbeck A/S · collab
Parallel-groupOpen-labelTreatment
Summary
This study evaluated the safety and evaluate the safety and tolerability of open-label brexpiprazole (2 - 4 mg/day, with a starting dose of 2 mg/day) for the treatment of adult subjects with bipolar I disorder. All participants received a starting dose of brexpiprazole.
Timeline
- Start
- 2017-10-24
- Primary completion
- 2019-07-31
- Completion
- 2019-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brexpiprazole | Small molecule | 2 mg | Oral |
| Subject | Brexpiprazole | Small molecule | 3 mg | Oral |
| Subject | Brexpiprazole | Small molecule | 4 mg | Oral |