NCT02013531

Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms

Protocol 331-13-002: An Exploratory, Multicenter, Open-label, Flexible-dose Trial of Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Adults With Major Depressive Disorder and Anxiety Symptoms

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 37 (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 investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment in subjects with major depressive disorder and anxiety symptoms, who are experiencing an inadequate selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response.

Conditions

• Major Depressive Disorder
• Anxiety

Interventions

Type	Name	Description
DRUG	Brexpiprazole	Treatment (6 weeks) - Up to 3mg/day, once daily dose, tablets, orally

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-05-01
• Completion: 2014-06-01
• First posted: 2013-12-17
• Last updated: 2016-03-29
• Results posted: 2016-03-29

Locations

21 sites across 1 country: United States