Brexpiprazole Treatment for Bipolar I Depression

Bipolar disorder (BD) is a frequent and lifelong recurrent mood disorder with treatment-resistant depressive episodes. Importantly, depressive symptoms and cognitive decline are major determinants of functionality and quality of life in this clinical population. There is robust evidence that individuals with BD have neurocognitive deficits (especially in memory and executive functioning domains) compared to the healthy population. These deficits are present in all mood states and can greatly affect patients' functional capacity, often more so than mood symptoms themselves. Many pharmacological treatments for BD adversely affect cognition, and those that are beneficial can be difficult to use. There is thus a pressing need to identify a safe, easy-to-use medication that can target both cognitive deficits and depressive symptoms in BD. It is expected that Brexpiprazole adjunctive treatment will be efficacious in treating BD type I and type II depression by improving mood symptoms, as well as cognitive capacity and global functioning, and that such changes will be accompanied by concurrent alterations in associated brain structures.

NCT Number	NCT04569448
Lead Sponsor	Douglas Mental Health University Institute Collaborators: McMaster University, Jewish General Hospital
Conditions	Bipolar Depression
Enrollment	58 participants
Start Date	2021-05-10
Primary Completion	2025-02 (estimated)
Study Completion	2025-02 (estimated)
Updated on ClinicalTrials.gov	2024-08-07