Principal Investigator

Dr. Serge Beaulieu

Description of study

This study is examining the efficacy of cannabidiol (also known as CBD) in treating episodes of depression in people diagnosed with bipolar disorder type I or II who have not responded to adequate trials with other treatments. This study is being conducted at multiple sites in Canada, and participants are randomly assigned to receive up to 600 mg of CBD or an identical placebo to take daily for 6 weeks. The study is also double-blind, which means that neither the participant nor the study staff will know which treatment they are receiving. The study procedures involve 5 clinical visits and one follow-up phone call 2 weeks after the last dose of study medication is taken.

Financial compensation

Yes

Functioning

Our team will contact you by phone to confirm your eligibility. If you are eligible, you will be invited to the Douglas for a screening visit. During this visit, you will learn about the study and provide consent, complete a physical exam, provide a blood sample, and complete questionnaires with the research team and study clinician. If you meet the criteria, you will be enrolled in the study. The study lasts six weeks and includes taking prescribed CBD or placebo, attending regular follow-ups with the study clinician and research team. Over the course of the study, you will be asked about your mental and physical health, complete two brief neurocognitive tests, and provide three blood samples. A final follow-up phone call 2 weeks after the end of your participation will be done to check-in on how you are doing. The procedures involved in the study will require about 7-8 hours of your time in total spread out across all the visits.

Benefits

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

Eligibility criteria

• 19-70 Years old
• Have a physician diagnosis of Bipolar I or II
• Must be taking a mood stabilising medication
• Must currently be expieriencing a depressive episode
• Must not have current or past month daily use of CBD or Cannabis
• Must not have alcohol or subtance use disorder in the last 6 months
• Must not be pregnant, lactating, anticipating pregnancy, or absence of contraceptive use
• Current depressive episode must not have lasted longer than 12 month

Information

• Location: Bipolar Disorders Lab, Newman Pavillion H-1141, Douglas Mental Health Institute
• Contact: 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