NCT02013609

Brexpiprazole (OPC-34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment

Protocol 331-13-003: An Exploratory, Multicenter, Open-label, Flexible-dose Trial of Brexpiprazole (OPC 34712) as an Adjunctive Treatment in Active Adults, 18 to 35 Years Old, With Major Depressive Disorder Who Are in a School or Work Environment.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Not accepted

Summary

To investigate the efficacy and safety of flexibly dosed adjunctive brexpiprazole treatment in active adults with MDD, 18 to 35 years old, who are experiencing an inadequate selective serotonin reuptake inhibitor (SSRI)/serotonin norepinephrine reuptake inhibitor (SNRI) response in a school or work environment.

Conditions

• MDD

Interventions

Type	Name	Description
DRUG	Brexpiprazole	Treatment 12 weeks) - Up to 3 mg/day, once daily dose, tablets, orally

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-09-01
• Completion: 2014-10-01
• First posted: 2013-12-17
• Last updated: 2016-03-29
• Results posted: 2016-03-29

Locations

24 sites across 1 country: United States