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New treatment option for Bipolar Disorder
Official title Cannabidiol for Bipolar Depression (CBD-BD)
ClinicalTrials.gov ID: NCT05867849
What this study is testing
What is Cannabidiol?
Cannabidiol is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for bipolar disorder.
Also referred to as CBD.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Time commitment: about 10 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 19 to 70
You may be able to join if
- Males or females aged 19 to 70 years (inclusive).
- DSM-5 diagnosis of BD I or BD II, AND a current major depressive episode confirmed by MINI 7.0.2 .
- All patients must be taking either a mood stabilizer (i.e. lithium or valproate; lamotrigine monotherapy as a mood stabilizer is acceptable for BD II...
- Have received a minimum of 6-weeks treatment at adequate doses for treatment of current depressive episode with at least one CANMAT recommended...
- A MADRS score of ≥ 20 and a YMRS score of ≤ 12 (these cut off scores are standard in bipolar depression RCTs).
You likely can't join if
- Current depressive episode greater than 12 months.
- A history of rapid cycling, defined as ≥ 4 mood episodes in the preceding 12 months.
- Current unstable or inadequately treated medical illness with the exception of current depression.
- Recently started taking a CANMAT-recommended treatment for the management of acute bipolar depressive episode, but has not had a trial for a minimum...
- Recently (i.e. within the past 8 weeks) began structured psychotherapy (i.e. cognitive-behavioral therapy, interpersonal psychotherapy...
- Recently (i.e. within the past 8 weeks) started taking a stimulant medication. Concomitant treatment with stimulant medication is acceptable provided...
See the full eligibility criteria
- Males or females aged 19 to 70 years (inclusive).
- DSM-5 diagnosis of BD I or BD II, AND a current major depressive episode confirmed by MINI 7.0.2 .
- All patients must be taking either a mood stabilizer (i.e. lithium or valproate; lamotrigine monotherapy as a mood stabilizer is acceptable for BD II patients only and not for BD I) OR an atypical antipsychotic OR a...
- Have received a minimum of 6-weeks treatment at adequate doses for treatment of current depressive episode with at least one CANMAT recommended first-line treatment for bipolar I disorder (i.e. lithium, lamotrigine...
- A MADRS score of ≥ 20 and a YMRS score of ≤ 12 (these cut off scores are standard in bipolar depression RCTs).
- Inpatient or outpatient status.
- All participants are required to agree to practice highly effective methods of contraception (i.e. hormonal contraceptives, intrauterine device or system, vasectomy and tubal ligation, or double barrier methods of...
- The capability of understanding, consenting to and complying with study requirements.
- All concomitant medication must be at a stable dose for two weeks prior to the randomization visit.
- Current depressive episode greater than 12 months.
- A history of rapid cycling, defined as ≥ 4 mood episodes in the preceding 12 months.
- Current unstable or inadequately treated medical illness with the exception of current depression.
- Recently started taking a CANMAT-recommended treatment for the management of acute bipolar depressive episode, but has not had a trial for a minimum of 6 weeks with adequate doses.
- Recently (i.e. within the past 8 weeks) began structured psychotherapy (i.e. cognitive-behavioral therapy, interpersonal psychotherapy, family-focused therapy, or interpersonal and social rhythm therapy).
- Recently (i.e. within the past 8 weeks) started taking a stimulant medication. Concomitant treatment with stimulant medication is acceptable provided that the dose has been stable for a minimum of 8 weeks and is taken...
- Current use of clozapine, tricyclic antidepressants, monoamine oxidase inhibitors, and first-generation antipsychotics.
- A history of non-response or intolerance to CBD.
- Current or past month daily use of CBD, or any product or drug that contains CBD. Occasional users will be included if they agree to refrain from using during the trial.
- A history of non-response to electroconvulsive therapy for the current depressive episode.
- A current diagnosis of other primary psychiatric disorders as assessed by a study investigator to be primary and causing greater impairment than BD.
- A lifetime history of a primary psychotic disorder (e.g. schizoaffective disorder, bipolar subtype) according to DSM-5 criteria.
- Patients who have met the DSM-5 criteria for a substance use disorder (except for nicotine or caffeine) within the past 6 months.
- Significant active suicidal ideation (as evidenced by MADRS suicide item ≥ 4).
- Pregnancy or lactation.
- Liver function tests (AST and ALT) three times the upper limit of normal.
The study team makes the final eligibility decision.
Where it's taking place
- Vancouver, British Columbia, Canada
- Hamilton, Ontario, Canada
- Kingston, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 19 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Vancouver, British Columbia, Canada; Hamilton, Ontario, Canada; Kingston, Ontario, Canada; Toronto, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.