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Study identifier: NCT04569448 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Brexpiprazole Treatment for Bipolar I Depression

Condition: Bipolar Depression  ·  Sponsor: Douglas Mental Health University Institute

PhasePhase 3
Planned participants58
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Nada Khalil, BA  ·  514 444 5397  ·  nada.khalil.comtl@ssss.gouv.qc.ca

Paola Lavin Gonzalez, MD, MSc  ·  438 389 8181  ·  maria.lavingonzalez@mail.mcgill.ca

Always discuss trial participation with your own doctor first.

Locations (3)

McMaster UniversityHamilton, Ontario, CanadaTerminated
Jewish General HospitalMontreal, Quebec, CanadaWithdrawn
Douglas Mental Health University InstituteMontreal, Quebec, CanadaRecruiting

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Source record: clinicaltrials.gov/study/NCT04569448