Cannabidiol for Bipolar Depression (CBD-BD) (NCT05867849)
Cannabidiol Adjunctive Therapy for Acute Bipolar Depression: A Randomized Double-Blind, Placebo Controlled Trial
๐ฉบ Plain-English Summary (8th-Grade Level)
Bipolar disorder (BD) is a lifelong condition characterized by recurrent episodes of depression and (hypo)mania. Periods of chronic and recurring depressive episodes are more common and can be severely disabling. Effective treatments exist; however, a significant portion of bipolar depressed patients do not respond to or have difficulty tolerating many of these interventions and thus look beyond established treatments to achieve symptom relief. Cannabidiol (CBD), a chemical from the Cannabis sativa plant, has shown to have some beneficial effects on mood symptoms in a few small studies which assessed its effects in other mental and physical health conditions, but no large studies have been conducted to assess its safety and efficacy in bipolar depression. Additionally, several clinical studies have shown CBD to be safe and tolerable. The primary objective of this study is to assess the effectiveness, safety and tolerability of cannabidiol in patients with bipolar depression (BD I or BD II) who have not responded to adequate trials with at least one first-line treatment for bipolar depression in comparison to those who will be treated with placebo. Placebo is an inactive substance that looks identical to the study medication but contains no therapeutic ingredient. This study is a randomized (like the flip of a coin), double-blind (you and the study team will not know which treatment arm you receive) study in which participants will receive either CBD or placebo added to their current treatment. Participants will have 5 clinical appointments and a phone appointment over a period of 10 weeks.
Who can join: Review the eligibility criteria below.
Location: UBC Mood Disorders Centre โ Vancouver, British Columbia
Age range: 19 Years to 70 Years
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (6 Sites)
- UBC Mood Disorders Centre โ Vancouver, British Columbia
- St. Joseph's Healthcare โ Hamilton, Ontario
- Providence Care Hospital โ Kingston, Ontario
- Sunnybrook Health Sciences Centre โ Toronto, Ontario
- Centre for Addiction and Mental Health (CAMH) โ Toronto, Ontario
- Douglas Mental Health University Institute โ Montreal, Quebec
๐ Contact the Study Coordinator
Phone: (604) 822-7294
Email: nazlin.walji@ubc.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ 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 ยง 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 Disorder
- Early Intervention for Youth at High Risk for Bipolar Disorder โ Pittsburgh, Pennsylvania
- Evaluation of the Genetics of Bipolar Disorder โ Bethesda, Maryland
- Narrative Enhancement and Cognitive Therapy for Self-Stigma in Youth โ Toronto, Ontario
- Low Field Magnetic Stimulation: Imaging Biomarkers in Geriatric Bipolar Depression โ Belmont, Massachusetts
- Characterizing MyMood Patterns of Use โ Toronto, Ontario
- A Future Thinking Intervention for Comorbid Tobacco Use Disorder and Bipolar Disorder โ Boston, Massachusetts
Explore by condition: All Bipolar Disorder clinical trials
๐ก 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.