NCT04830215

Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder

A Phase 4, Multicenter, Open-label, Interventional Trial to Assess the Effects on Engagement of Flexible-dose Brexpiprazole (OPC-34712) as Adjunctive Therapy for the Treatment of Adults With Major Depressive Disorder

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The clinical trial will investigate the effect of brexpiprazole on the concept of life engagement in participants with Major Depressive Disorder (MDD) with a current depressive episode.

Detailed description

This is a phase 4, multicenter, open-label, flexible dose trial designed to assess the effects of brexpiprazole (flexible dose; 0.5 to 2 milligrams \[mg\], once daily \[QD\]) as adjunctive therapy to antidepressant therapy (ADT) on life engagement in participants with MDD. This trial is being conducted in line with the Canadian Product Monograph.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Brexpiprazole	Oral brexpiprazole tablets as adjunctive therapy to ADT

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-05-27
• Completion: 2022-05-27
• First posted: 2021-04-05
• Last updated: 2024-02-02
• Results posted: 2024-02-02

Locations

1 site across 1 country: Canada