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

NCT01052077 ↗

Phase 2 Completed 773 enrolled Otsuka Pharmaceutical Development & Commercialization, Inc.

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive substance) in addition to an FDA approved antidepressant in order to determine if the study medication is effective as an add on treatment of MDD.

Timeline

Start: 2010-03
Primary completion: 2011-10
Completion: 2011-11

Outcome

Missed primary endpoint

registry analysis (superiority or other test); Brexpiprazole vs Placebo; p = 0.1416; Mean Difference (Final Values) -1.18 (95% CI -2.75 to 0.39) NCT01052077 ↗

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	—	Oral