NCT01447576

Study of Safety & Tolerability of OPC-34712 as Adjunctive Therapy in Treatment of Adult Patients With Major Depressive Disorder

A Phase 2, Multicenter, Open-label Study to Assess the Safety and Tolerability of Oral OPC-34712 as Adjunctive Therapy in Adult Patients With Major Depressive Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1,036 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the long-term safety, tolerability and efficacy of oral OPC-34712 as adjunctive therapy in the treatment of adult patients with Major Depressive Disorder (MDD).

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	ADT	Once daily dosing during the duration of the study.
DRUG	OPC-34712	OPC-34712, Oral Tablets, 0.25 - 3 mg

Timeline

• Start date: 2009-09-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2011-10-06
• Last updated: 2015-11-06
• Results posted: 2015-11-06

Locations

32 sites across 1 country: United States