Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Phase 2 Completed 850 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

Primary: To compare the efficacy of OPC-34712 to placebo as adjunctive treatment to an assigned open-label marketed antidepressant treatment (ADT)in patients who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed ADT.

Timeline

Start: 2009-05
Primary completion: 2010-06
Completion: 2010-07

Outcome

Met primary endpoint

registry analysis (superiority or other test); OPC-34712 1.5 ± 0.5 mg High Dose vs Placebo; p = 0.0303; Mean Difference (Final Values) -2.14 (95% CI -4.08 to -0.21); ANCOVA NCT00797966 ↗

Publications

Hobart M, Zhang P, Weiss C, Meehan SR, Eriksson H. Adjunctive Brexpiprazole and Functioning in Major Depressive Disorder: A Pooled Analysis of Six Randomized Studies Using the Sheehan Disability Scale. Int J Neuropsychopharmacol. 2019 Mar 1;22(3):173-179. doi: 10.1093/ijnp/pyy095.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Brexpiprazole	Small molecule	1 mg	Oral
Subject	Brexpiprazole	Small molecule	4 mg	Oral
Background	Desvenlafaxine	Other / unclassified	10 mg	—
Background	Desvenlafaxine	Other / unclassified	225 mg	—
Background	Escitalopram	Small molecule	10 mg	—
Background	Escitalopram	Small molecule	225 mg	—
Background	Fluoxetine	Small molecule	10 mg	—
Background	Fluoxetine	Small molecule	225 mg	—
Background	Paroxetine	Small molecule	10 mg	—
Background	Paroxetine	Small molecule	225 mg	—
Background	Sertraline	Small molecule	10 mg	—
Background	Sertraline	Small molecule	225 mg	—
Background	Venalfaxine	Unknown	10 mg	—
Background	Venalfaxine	Unknown	225 mg	—