drugset / Trial / NCT03487198
The Safety and Efficacy of Brexpiprazole as Adjunctive Therapy in the Treatment of Major Depressive Disorder
RandomizedParallel-groupTriple-blindTreatment
Summary
This study is a multicenter, randomized, double-blind, placebo-controlled trial designed to assess the efficacy and safety of brexpiprazole as adjunctive therapy in the treatment of Major Depressive Disorder. A total of approximately 1100 subjects will be enrolled into the single-blind treatment for 6 weeks, and 480 incomplete responders will be randomized to brexpiprazole (2\~3 mg) or placebo in a 1:1 ratio (approximately 240 subjects in each group), for treatment of 6 weeks.
Timeline
- Start
- 2018-05-30
- Primary completion
- 2019-05-30
- Completion
- 2019-05-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brexpiprazole | Small molecule | 2 mg | Oral |
| Subject | Brexpiprazole | Small molecule | 3 mg | Oral |