drugset / Trial / NCT03487198

The Safety and Efficacy of Brexpiprazole as Adjunctive Therapy in the Treatment of Major Depressive Disorder

NCT03487198

Phase 3 Terminated 65 enrolled Otsuka Beijing Research Institute
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

EvaluationDrugModalityDoseRoute
Subject Brexpiprazole Small molecule 2 mg Oral
Subject Brexpiprazole Small molecule 3 mg Oral