Conditions: Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders
Keywords: OPC-34712 brexpiprazole Major Depressive Disorder Adjunctive Treatment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2182
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Matching Placebo and assigned ADT arm 2: Brexpiprazole, flexible dose and assigned ADT arm 3: Seroquel XR, flexible dose and assigned ADT

Interventions: intervention 1: Brexpiprazole intervention 2: Seroquel XR intervention 3: Placebo
Intervention descriptions: intervention 1: tablet/capsule intervention 2: tablet/capsule intervention 3: tablet/capsule

Protocol document: