NCT01052077

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

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Safety and Efficacy of OPDC-34712 (1 to 3 mg/Day) as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 773 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Double-blind study wherein patients with Major Depressive Disorder (MDD) will receive either from 1 to 3 mg a day of study medication (OPC-34712)or placebo (an inactive substance) in addition to an FDA approved antidepressant in order to determine if the study medication is effective as an add on treatment of MDD.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	OPC-34712	Tablets, Oral, 1 - 3 mg OPC-34712
DRUG	Placebo	Placebo
DRUG	ADT

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-10-01
• Completion: 2011-11-01
• First posted: 2010-01-20
• Last updated: 2015-11-02
• Results posted: 2015-11-02

Locations

43 sites across 1 country: United States