NCT01727726

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

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,182 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Depressive Disorder
• Depression
• Depressive Disorder, Major
• Mood Disorders
• Mental Disorders

Interventions

Type	Name	Description
DRUG	Brexpiprazole	tablet/capsule
DRUG	Seroquel XR	tablet/capsule
DRUG	Placebo	tablet/capsule

Timeline

• Start date: 2012-12-01
• Primary completion: 2016-10-17
• Completion: 2016-11-10
• First posted: 2012-11-16
• Last updated: 2018-06-08
• Results posted: 2018-06-08

Locations

76 sites across 7 countries: United States, Canada, France, Germany, Poland, Russia, Serbia