Cannabidiol for Bipolar Depression (CBD-BD) (CBD-BD)
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ClinicalTrials.gov Identifier: NCT05867849 |
Recruitment Status :
Recruiting
First Posted : May 22, 2023
Last Update Posted : January 10, 2024
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Tracking Information | |||||||||
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First Submitted Date ICMJE | May 9, 2023 | ||||||||
First Posted Date ICMJE | May 22, 2023 | ||||||||
Last Update Posted Date | January 10, 2024 | ||||||||
Actual Study Start Date ICMJE | October 15, 2023 | ||||||||
Estimated Primary Completion Date | December 2029 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
Improvement in depressive symptoms in bipolar patients treated with Cannabidiol vs Placebo adjunctive therapy [ Time Frame: 6 weeks ] The Montgomery Asberg Depression Rating Scale (MADRS) will be used to measure change in depressive symptoms from baseline to endpoint. Scores range from 0 to 60, and lower scores reflect better clinical outcomes.
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Cannabidiol for Bipolar Depression (CBD-BD) | ||||||||
Official Title ICMJE | Cannabidiol Adjunctive Therapy for Acute Bipolar Depression: A Randomized Double-Blind, Placebo Controlled Trial | ||||||||
Brief Summary | 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 the 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. |
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Detailed Description | This is a Phase 3, 6-week, double-blind, parallel group randomized controlled trial to assess the efficacy, safety and tolerability of adjunctive CBD vs placebo in patients with acute bipolar depression (BD I or BD II) who have not responded to adequate trials with at least one first-line treatment for bipolar I disorder (i.e. lithium, lamotrigine, lurasidone, or quetiapine either as monotherapy or adjunctive therapy), or at least one first or second-line treatment for bipolar II depression (i.e. quetiapine, lithium, lamotrigine, sertraline, or venlafaxine as monotherapy or adjunctive therapy, or bupropion adjunctive therapy). After the baseline visit, patients who meet the eligibility criteria will enter a 6-week double-blind treatment phase during which participants will be randomized to adjunctive CBD or identical placebo. Participants will be assessed at the screening visit, baseline visit, weeks 2, 4, and 6, or endpoint visit. All participants will receive a follow-up telephone call 2 weeks after the 6-week study endpoint or early termination visit to assess well-being. All participants will continue treatment with their mood stabilizer and/or atypical antipsychotic as prescribed by their treating physicians. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Phase 3 | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Bipolar Disorder | ||||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
360 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | December 2030 | ||||||||
Estimated Primary Completion Date | December 2029 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 19 Years to 70 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Canada | ||||||||
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Administrative Information | |||||||||
NCT Number ICMJE | NCT05867849 | ||||||||
Other Study ID Numbers ICMJE | H23-00105 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Nazlin Walji, University of British Columbia | ||||||||
Original Responsible Party | Same as current | ||||||||
Current Study Sponsor ICMJE | University of British Columbia | ||||||||
Original Study Sponsor ICMJE | Same as current | ||||||||
Collaborators ICMJE | Not Provided | ||||||||
Investigators ICMJE |
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PRS Account | University of British Columbia | ||||||||
Verification Date | January 2024 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |