drugset / Trial / NCT03874494
Safety and Efficacy of Brexpiprazole in the Treatment of Schizophrenia
RandomizedParallel-groupTriple-blindTreatment
Summary
This study is a phase III, multicenter, randomized, double-blind, active-controlled, non-inferiority trial designed to assess the efficacy and safety of Brexpiprazole in the Treatment of Adults With Acute Schizophrenia. A total of approximately 370 subjects will be included in the study, and randomized to Brexpiprazole (2\~4 mg/d) or Aripiprazole (10\~20 mg/d) in a 1:1 ratio.
Timeline
- Start
- 2019-11-27
- Primary completion
- 2021-08-06
- Completion
- 2021-09-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aripiprazole | Other / unclassified | 10 mg | Oral |
| Comparator | Aripiprazole | Other / unclassified | 20 mg | Oral |
| Subject | Brexpiprazole | Small molecule | 2 mg | Oral |
| Subject | Brexpiprazole | Small molecule | 4 mg | Oral |