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A Study of Flexible-dose Brexpiprazole as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial

Depression Clinical Trial

Official title:
A Phase 3, Multicenter, Randomized, Double-blind, Placebo and Active Comparator Controlled Trial of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Delphinus Trial

Clinical Trial Summary

To compare the efficacy of brexpiprazole (flexible dose) with placebo as adjunctive therapy to an assigned open label antidepressant therapy (ADT) in the proposed subject population with MDD.

Clinical Trial Description

This is a trial designed to assess the safety and efficacy of brexpiprazole (flexible dose) as adjunctive therapy to an assigned known anti-depressant in depressed subjects. The trial consists of a continuous 18-week double-blind treatment period with a 30-day follow-up. Subjects who complete all trial visits through the Week 18 visit may be offered entry into an optional open-label rollover trial. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01727726
Study type Interventional
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact
Status Completed
Phase Phase 3
Start date December 2012
Completion date November 10, 2016
View Details
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