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Cannabidiol for Bipolar Depression (CBD-BD Trial)
Phase 3
Recruiting
Led By Lakshmi N Yatham, MBBS, MRCPsy
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 6
Awards & highlights
CBD-BD Trial Summary
This trial will study the effectiveness, safety, and tolerability of Cannabidiol (CBD) in treating bipolar depression. Participants receive either CBD or placebo, and results are compared over 10 weeks.
Who is the study for?
Adults aged 19-70 with Bipolar Disorder (Type I or II) experiencing a major depressive episode, despite having tried at least one recommended treatment. They must be on stable doses of mood stabilizers or antipsychotics and agree to contraception if applicable. Excluded are those with certain liver issues, recent substance abuse, non-response to ECT, other primary psychotic disorders, severe suicidal ideation, pregnancy/lactation, intolerance to CBD or rapid cycling bipolar disorder.Check my eligibility
What is being tested?
The trial is testing the effectiveness of Cannabidiol (CBD) for treating depression in bipolar disorder compared to a placebo. Participants will add either CBD or placebo to their current treatment over 10 weeks and attend clinical appointments. The study is randomized and double-blind so neither participants nor researchers know who receives which treatment.See study design
What are the potential side effects?
While several studies have shown CBD as safe and tolerable generally, potential side effects specific to this trial aren't listed but may include typical reactions associated with cannabis-derived products such as changes in appetite or mood, dizziness, dry mouth, nausea.
CBD-BD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Improvement in depressive symptoms in bipolar patients treated with Cannabidiol vs Placebo adjunctive therapy
Secondary outcome measures
Adverse events
Daily functioning
Health services utilization
+15 moreSide effects data
From 2022 Phase 2 & 3 trial • 90 Patients • NCT0438761738%
Tiredness
24%
Drowsiness
24%
Poor sleep
22%
Constipation
18%
Poor Appetite
16%
Dizziness
9%
Headache
7%
Diarrhea
7%
Nausea
4%
Itching
100%
80%
60%
40%
20%
0%
Study treatment Arm
CBD Oil Group
Control Group
CBD-BD Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: CannabidiolExperimental Treatment1 Intervention
Cannabidiol 200 - 600 mg / day added to current treatment for 6 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Placebo added to current treatment for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
2021
Completed Phase 3
~1010
Find a Location
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,418 Previous Clinical Trials
2,466,758 Total Patients Enrolled
14 Trials studying Bipolar Disorder
1,371 Patients Enrolled for Bipolar Disorder
Lakshmi N Yatham, MBBS, MRCPsyPrincipal InvestigatorUniversity of British Columbia, Department of Psychiatry
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- CBD treatments haven't worked for me or caused side effects.I have been experiencing a depressive episode for more than 6 months.I have used CBD or CBD products daily for the last month.My mental health condition is more severe than bipolar disorder.I do not have any untreated or unstable illnesses, except for depression.I am currently receiving medical care, either staying in the hospital or visiting as an outpatient.I have been diagnosed with Bipolar Disorder and am currently experiencing a major depressive episode.I have been treated for bipolar disorder with recommended medications for at least 6 weeks.Electroconvulsive therapy did not improve my condition.I am on medication for mood stabilization or psychosis at the right doses.I understand and can follow the study's requirements.My medication doses have been stable for the last two weeks.I am between 19 and 70 years old.I am using birth control or will not have sex to avoid pregnancy.
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an age cap for participants of this trial?
"This medical trial requires that all participants be between 19 and 70 years old, in accordance with the established criteria."
Answered by AI
How reliable is Cannabidiol in terms of its effect on people's health?
"The safety of Cannabidiol has been rated a 3 on our scale due to the existence of evidence-based efficacy and multiple rounds with credentials verifying its safety."
Answered by AI
May I be included in this scientific trial?
"In order to qualify for this trial, participants should be between 19 and 70 years old and have been diagnosed with bipolar disorder. Approximately 360 individuals are needed in total."
Answered by AI
Is this experiment being conducted at a number of facilities located in this urban area?
"The UBC Mood Disorders Centre in Vancouver, Dalhousie University in Halifax, and St. Joseph's Healthcare in Hamilton are among the 8 sites that have been enlisted to recruit participants for this research."
Answered by AI
Is this medical study still welcoming new participants?
"The clinical trial's page on clinicaltrials.gov reports that this is presently inactive; the investigation was first posted on May 1st 2023 and last updated 18 days later. However, there are over a thousand other trials in progress seeking participants at this time."
Answered by AI
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