A Study of Brexpiprazole in Patients With Major Depressive Disorder

Summary

The purpose of this 14 week, randomized, double-blind, placebo controlled study is to assess the safety and efficacy of brexipiprazole to placebo as adjunctive treatment to an assigned open-label marketed antidepressant therapy (ADT) in patients with Major Depressive Disorder.

Timeline

Start

2018-07-30

Primary completion

2022-06-06

Completion

2022-07-04

Outcome

Met primary endpoint

registry analysis (superiority test); Brexpiprazole 2 mg vs Placebo; p = 0.0312; Mean Difference (Final Values) -1.4 (95% CI -2.7 to -0.1); MMRM NCT03697603 ↗

registry analysis (superiority test); Brexpiprazole 1 mg vs Placebo; p = 0.0089; Mean Difference (Final Values) -1.7 (95% CI -3.0 to -0.4); MMRM NCT03697603 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brexpiprazole	Small molecule	1 mg	Oral
Subject	Brexpiprazole	Small molecule	2 mg	Oral

Indications