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: 1539
Healthy volunteers: no

Brief summary:
To compare the effect of OPC-34712 (brexpiprazole) to the effect of placebo (an inactive substance) as add on treatment to an assigned FDA approved antidepressant treatment (ADT) in patients with Major Depressive Disorder who demonstrate an incomplete response to a prospective trial of the same assigned FDA approved ADT

Detailed description:

Arms:
arm 1: Drug: OPC-34712 + ADT

Drug: Placebo + ADT arm 2: Drug: Placebo + ADT

Interventions: intervention 1: OPC-34712 + ADT intervention 2: Placebo + ADT intervention 3: Placebo + ADT
Intervention descriptions: intervention 1: Tablets, Oral, 1 or 3 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT) intervention 2: Placebo + FDA Approved Antidepressant (ADT) intervention 3: Placebo + FDA Approved Antidepressant (ADT)

Protocol document: