Brexpiprazole Treatment for Bipolar I Depression (NCT04569448)
Low-Dose Adjunctive Brexpiprazole in the Treatment of Bipolar I Depression: An Open-Label Study
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: McMaster University — Hamilton, Ontario
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (3 Sites)
- McMaster University — Hamilton, Ontario
- Jewish General Hospital — Montreal, Quebec
- Douglas Mental Health University Institute — Montreal, Quebec
📞 Contact the Study Coordinator
Phone: (514) 444-5397
Email: gabrielle.phillips.comtl@ssss.gouv.qc.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Bipolar Depression
- SYNCED - SYNChronized Eating in Bipolar Depression Study — Ottawa, Ontario
- Deep Brain Stimulation of Treatment-Resistant Bipolar Depression — Boston, Massachusetts
- Neurobiological Effects of Psilocybin in Treatment Resistant Bipolar Depression — Toronto, Ontario
- Ketogenic Intervention for Bipolar Depression — Rochester, Minnesota
- Effects of Acute Exercise and Ibuprofen on Symptoms, Immunity, and Neural Circuits in Bipolar Depression — Tulsa, Oklahoma
Explore by condition: All Bipolar Depression clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.