Actively Recruiting
Cannabidiol for Bipolar Depression (CBD-BD)
Led by University of British Columbia · Updated on 2025-04-23
360
Participants Needed
6
Research Sites
372 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cannabidiol for Bipolar Depression (CBD-BD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males or females aged 19 to 70 years (inclusive).
- DSM-5 diagnosis of bipolar disorder type I or II with a current major depressive episode confirmed by MINI 7.0.2.
- Currently taking a mood stabilizer (lithium, valproate, lamotrigine for BD II only), an atypical antipsychotic, or a combination at therapeutic doses.
- Have had at least 6 weeks of treatment at adequate doses with a recommended first-line treatment for bipolar depression.
- A MADRS score of 20 or higher and a YMRS score of 12 or lower.
- Inpatient or outpatient status.
- Agree to use highly effective contraception methods or abstain from heterosexual intercourse; females without childbearing potential must be postmenopausal for at least 1 year or surgically sterile.
- Able to understand, consent to, and comply with study requirements.
- All concomitant medications must be at stable doses for at least two weeks before randomization.
You will not qualify if you...
- Current depressive episode lasting more than 12 months.
- History of rapid cycling (4 or more mood episodes in the past 12 months).
- Unstable or inadequately treated medical illness except for depression.
- Recently started recommended treatment for bipolar depression without at least 6 weeks trial at adequate doses.
- Recently started structured psychotherapy within the past 8 weeks.
- Recently started stimulant medication within the past 8 weeks unless dose has been stable for 8 weeks.
- Current use of clozapine, tricyclic antidepressants, monoamine oxidase inhibitors, or first-generation antipsychotics.
- History of non-response or intolerance to cannabidiol.
- Current or daily use of cannabidiol products in the past month; occasional users must agree to refrain during the trial.
- History of non-response to electroconvulsive therapy for current depressive episode.
- Current diagnosis of other primary psychiatric disorders causing greater impairment than bipolar disorder.
- Lifetime history of primary psychotic disorders such as schizoaffective disorder.
- Substance use disorder (except nicotine or caffeine) within past 6 months.
- Significant active suicidal ideation (MADRS suicide item score 4 or higher).
- Pregnancy or breastfeeding.
- Liver function tests (AST and ALT) three times above the upper limit of normal.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
UBC Mood Disorders Centre
Vancouver, British Columbia, Canada, V6T 1Z3
Actively Recruiting
2
St. Joseph's Healthcare
Hamilton, Ontario, Canada, L8N 3K7
Actively Recruiting
3
Providence Care Hospital
Kingston, Ontario, Canada, K7L 4X3
Actively Recruiting
4
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Not Yet Recruiting
5
Centre for Addiction and Mental Health (CAMH)
Toronto, Ontario, Canada, M6J1H4
Not Yet Recruiting
6
Douglas Mental Health University Institute
Montreal, Quebec, Canada, H4H 1R3
Not Yet Recruiting
Research Team
N
Nazlin Walji, BSc
CONTACT
S
Shannon Reid, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here