drugset / Trial / NCT04830215
Brexpiprazole as Adjunctive Therapy in Adults With Major Depressive Disorder
Phase 4
Completed
122 enrolled
Otsuka Pharmaceutical Development & Commercialization, Inc.
Lundbeck Canada Inc. · collabOtsuka Canada Pharmaceutical Inc. · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2021-04-01
- Primary completion
- 2022-05-27
- Completion
- 2022-05-27
Publications
- Therrien F, Chokka P, Habert J, Ismail Z, McIntyre RS, Dine J, Brown TM, Zhang Z, MacKenzie EM, Ward CL. Patient-reported efficacy of adjunctive brexpiprazole in major depressive disorder in a phase 4, open-label, interventional study. Curr Med Res Opin. 2025 Aug;41(8):1511-1522. doi: 10.1080/03007995.2025.2558140. Epub 2025 Sep 16.
- Therrien F, Ward C, Chokka P, Habert J, Ismail Z, McIntyre RS, MacKenzie EM. Adjunctive Brexpiprazole for Patient Life Engagement in Major Depressive Disorder: A Canadian, Phase 4, Open-Label, Interventional Study: Brexpiprazole d'appoint pour l'engagement dans la vie des patients souffrant de trouble depressif majeur: une etude interventionnelle canadienne ouverte de phase 4. Can J Psychiatry. 2024 Jul;69(7):513-523. doi: 10.1177/07067437241233965. Epub 2024 Mar 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Brexpiprazole | Small molecule | 0.5 mg | Oral |
| Subject | Brexpiprazole | Small molecule | 2 mg | Oral |