Conditions: Major Depressive Disorder
Keywords: OPC-34712, Major Depressive Disorder, Adjunctive Treatment
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 850
Healthy volunteers: no

Brief summary:
Primary: To compare the efficacy of OPC-34712 to placebo as adjunctive treatment to an assigned open-label marketed antidepressant treatment (ADT)in patients who demonstrate an incomplete response to a prospective eight week trial of the same assigned open-label marketed ADT.

Detailed description:
A comparison of the Fixed dose arm (OPC-31712, 0.15 mg) verses placebo was included as a general secondary efficacy variable and results for this dose group comparison are included under each of the Outcome Measures.

Arms:
arm 1: OPC-34712 + ADT arm 2: Placebo + ADT

Interventions: intervention 1: OPC-34712 intervention 2: Placebo intervention 3: ADT
Intervention descriptions: intervention 1: Tablets, Oral, 1 - 4 mg OPC-34712 variable dose once daily, 14 weeks intervention 2: Tablets, Oral, 1- 4 mg OPC-34712 once daily, 14 weeks intervention 3: Tablets, 10 - 225 mgs, dose once daily, 14 weeks

Protocol document: