Conditions: Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders
Keywords: OPC-34712 brexpiprazole Major Depressive Disorder Adjunctive Treatment Anxious Distress
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 837
Healthy volunteers: no

Brief summary:
The purpose of this study is to assess the tolerability, safety, and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy in adult subjects with a diagnosis of MDD with and without anxious distress

Detailed description:
The introduction of atypical antipsychotics has created a renewed interest in adjunctive therapy for MDD, particularly for treatment-resistant MDD. Several atypical antipsychotics have been shown to enhance the response to ADT. This is a phase 3, multicenter, randomized, double-blind, placebo-controlled, fixed-dose trial designed to assess the safety and efficacy of brexpiprazole (2.0 mg/day) as adjunctive therapy to an assigned open-label ADT in depressed subjects with and without anxious distress.

Arms:
arm 1: Brexpiprazole + ADT arm 2: Placebo + ADT

Interventions: intervention 1: Placebo + ADT intervention 2: Brexpiprazole +ADT
Intervention descriptions: intervention 1: Placebo + ADT Placebo + FDA Approved Antidepressant (ADT) intervention 2: Brexpiprazole + ADT Tablet, Oral, 2mg brexpiprazole and FDA Approved Antidepressant (ADT)

Protocol document: