NCT01360632

Study of the Safety and Efficacy of Two Fixed Doses of OPC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder (the Polaris Trial)

A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety and Efficacy of Two Fixed Doses of OPDC-34712 as Adjunctive Therapy in the Treatment of Adults With Major Depressive Disorder, the Polaris Trial

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,539 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Depressive Disorder
• Depression
• Depressive Disorder, Major
• Mood Disorders
• Mental Disorders

Interventions

Type	Name	Description
DRUG	OPC-34712 + ADT	Tablets, Oral, 1 or 3 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT)
DRUG	Placebo + ADT	Placebo + FDA Approved Antidepressant (ADT)
DRUG	Placebo + ADT	Placebo + FDA Approved Antidepressant (ADT)

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-08-01
• Completion: 2013-09-01
• First posted: 2011-05-25
• Last updated: 2016-01-01
• Results posted: 2016-01-01

Locations

71 sites across 7 countries: United States, Canada, Germany, Hungary, Romania, Russia, Ukraine