Principal Investigator

Dr. Serge Beaulieu

Description of study

The purpose of this study is to assess the efficacy of Brexpiprazole medication in improving depressive symptoms in individuals affected by bipolar type I or II disorder and suffering a current depressive phase. With the BREX study, we hope to find a treatment that works quickly, avoids common side effects like switching to hypomania or weight gain, and effectively addresses the most persistent symptoms of bipolar depression, such as slowed movement, difficulty thinking, and changes in sleep or appetite. Participants will meet regularly with the study clinician and the research team to complete clinical questionnaires, cognitive tests, MRIs, actigraphy recordings for sleep quality measures, physical exams, bloodwork, and ECG.

Financial compensation

Yes

Functioning

Participants will first be contacted by phone to evaluate their possible eligibility for the study. Potentially eligible participants will be invited to an in-person screening visit, where they will undergo a physical exam, ECG, blood test, and clinical questionnaires. If found to be eligible, the baseline visit will take place, where we will conduct clinical interviews, questionnaires, an MRI, and cognitive tests. Participants will be prescribed Rexulti and regular visits will occur at week 1, 2, 4, 6, and 8. Participants who respond well to treatment will be invited to extend their participation up to 6 months if they are willing with monthly study visits. A final MRI will be done at 6 months to assess changes in brain volume in response to treatment, along with questionnaires and cognitive tests.

Benefits

By participating, you will significantly contribute to the advancement of research in bipolar disorder.

Eligibility criteria

• 18-75 years old
• French or English speaking
• Currently depressed
• Currently followed by a Douglas Clinician
• Must not be pregnant, lactating, anticipating pregnancy, or absence of contraceptive use
• Must not have a substance use disorder
• Must not have seizures currently controlled by medication
• Must not have a known eye disease
• Must not have current or a history of difficulty swallowing

Information

• Location: Bipolar Disorders Lab, Newman Pavillion H-1141, Douglas Mental Health Institute
• Contact: bipolar.researchlab.comtl@ssss.gouv.qc.ca or 514-444-5397
• How to participate: Please reach out to our team by emailing or calling us using the contact above, or by using the QR code below