NCT00797966

Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPC-34712 as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 850 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	OPC-34712	Tablets, Oral, 1 - 4 mg OPC-34712 variable dose once daily, 14 weeks
DRUG	Placebo	Tablets, Oral, 1- 4 mg OPC-34712 once daily, 14 weeks
DRUG	ADT	Tablets, 10 - 225 mgs, dose once daily, 14 weeks

Timeline

• Start date: 2009-05-01
• Primary completion: 2010-06-01
• Completion: 2010-07-01
• First posted: 2008-11-25
• Last updated: 2016-02-29
• Results posted: 2015-12-03

Locations

50 sites across 1 country: United States