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๐Ÿ›๏ธ Verified NIH Protocol โ€ข Sourced via U.S. National Library of Medicine (Last Synced: 2026-08-27)

Brexpiprazole Treatment for Bipolar I Depression

๐ŸŸข Recruiting Phase 3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Douglas Mental Health University Institute

๐Ÿฉบ Protocol Summary

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.

Primary Research Facility: McMaster University (Hamilton, Ontario)

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๐Ÿ“ Primary Site Map

Site: McMaster University โ€” Hamilton, Ontario

๐Ÿ“ All Participating Trial Locations (3 Sites)

Multi-Center Trial

This protocol is enrolling participants across multiple clinical centers:

1. McMaster University โ€” Hamilton, Ontario
2. Jewish General Hospital โ€” Montreal, Quebec
3. Douglas Mental Health University Institute โ€” Montreal, Quebec โ€ข Contact: (514) 444-5397

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๐Ÿ›๏ธ Official Government Provenance

NIH ClinicalTrials.gov Protocol Record

NCT Identifier: NCT04569448 โ€ข Last Synced: 2026-08-27
View on ClinicalTrials.gov โ†—
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