NCT03487198

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

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Evaluating the Safety and Efficacy of Brexpiprazole as Adjunctive Therapy in the Treatment of Major Depressive Disorder

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Otsuka Beijing Research Institute · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Screening phase: It can last up to 28 days and will begin when informed consent is signed. The screening phase will serve the following purposes: 1) To review the inclusion and exclusion criteria; 2) To allow for appropriate washout of prohibited medications; 3) To establish a pretreatment baseline of critical outcome measures. Single-blind Prospective Treatment Phase (Phase A): It lasts 8 weeks; the purpose of the Phase A is to select the MDD subjects with incomplete response to ADT. Randomized Double-blind Treatment Phase (Phase B): It lasts 6 weeks; the purpose of Phase B is to compare the efficacy and safety of Brexpiprazole as adjunctive therapy in the treatment of MDD patients with incomplete response to ADT. Continued Treatment Phase after Phase A (Phase A+): It lasts 6 weeks; the purpose of Phase A+ is to continue treatment for subjects with complete response to ADT and not satisfying the criteria for Phase B. Follow-up Phase: It lasts 4 weeks and only applies to the subjects from Phase B; the purpose of Follow-up Phase is to collect the safety information after the last dose of IMP.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Brexpiprazole	Brexpiprazole 2-3mg/day
DRUG	Placebo	Placebo 2-3 mg/day

Timeline

• Start date: 2018-05-30
• Primary completion: 2019-05-30
• Completion: 2019-05-30
• First posted: 2018-04-03
• Last updated: 2020-12-29

Locations

1 site across 1 country: China