- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00397605
Cannabinoids in Bipolar Affective Disorder
September 16, 2014 updated by: University of British Columbia
Cannabinoids in Bipolar Affective Disorder: A Controlled Pilot Study
Some people with bipolar disorder who use cannabis (marijuana) claim that it eases the symptoms of depression and mania.
There are many chemicals (called cannabinoids) found in cannabis but two particular ones appear to have medicinal (therapeutic) effects.
These two compounds are: delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD).
These cannabinoids appear to have mood, anxiety, and sedative effects as well as have antipsychotic and anticonvulsant properties.
This study will try to find out if these cannabinoids can be of benefit as an add-on treatment in bipolar disorder and what effects it has on thinking power and memory.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
This study will be a within-subject, random order, double-blind cross-over study with standard clinical and neuropsychological ratings.
Duration is 13 weeks per subject.
Clinical assessments including mood ratings will be performed weekly.
Instructions and practice on the use of the spray will be given under supervision during a 2-week run-in period before baseline.
Patients can control the dosage of cannabinoids according to their symptoms by administering up to a maximum of 48 pump-controlled sprays per day.
Patients will be asked to abstain from using cannabis (other than the study drug) during the study.
Patients will be treated for 4 weeks with either the sublingual THC:CBD spray or placebo spray.
This will be followed by a 2-week washout period before another 4 weeks of treatment with whichever study medication was not initially used.
Neurocognitive testing will be performed 3 times during the study.
A mood diary will be completed daily by each patient at home.
Study Type
Interventional
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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British Columbia
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Vancouver, British Columbia, Canada, V6T 2A1
- Department of Psychiatry, University of British Columbia
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Outpatients between the 19-60 years of age with a diagnosis of bipolar disorder.
- Women must not be currently pregnant and must use a reliable method of contraception for the duration of the study.
- Subjects must be on stable medication (4 weeks minimum) for their bipolar illness (symptomatic despite current treatment), must be able to provide written informed consent, must adequately understand written and verbal English.
Exclusion Criteria:
- Those not meeting the inclusion criteria and those not able to give informed consent.
- Women who are currently pregnant or nursing.
- Those at immediate risk of harming self or others;
- those who have a clinically significant medical illness or other significant psychiatric illness;
- currently abusing alcohol or drugs;
- currently being treated with an investigational medication or medication that is contraindicated with cannabinoids;
- have a known allergy to cannabis-based products.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Crossover
|
Randomized crossover study of 2 weeks of active study medication (maximum daily dosage of 60 mg) vs. 2 weeks of matching placebo.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine whether a standardized plant extract of cannabis containing a 1:1 ratio of THC & CBD can alleviate bipolar mood symptoms unresponsive to standard treatment. To be measured weekly over 13 weeks.
Time Frame: 13 weeks
|
13 weeks
|
Secondary Outcome Measures
Outcome Measure |
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To determine the effects on cognition.
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To be measured at baseline and at the end of each treatment phase.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Allan H. Young, Ph.D, University of British Columbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2006
Primary Completion (Anticipated)
December 1, 2013
Study Completion (Anticipated)
December 1, 2013
Study Registration Dates
First Submitted
November 7, 2006
First Submitted That Met QC Criteria
November 8, 2006
First Posted (Estimate)
November 9, 2006
Study Record Updates
Last Update Posted (Estimate)
September 18, 2014
Last Update Submitted That Met QC Criteria
September 16, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H06-00239
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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