Cannabinoids in Bipolar Affective Disorder

• ClinicalTrials.gov Identifier: NCT00397605
• Recruitment Status: Withdrawn
• First Posted: November 9, 2006
• Last Update Posted: September 18, 2014
• Sponsor: University of British Columbia
• Collaborator: Vancouver General Hospital
• Information provided by (Responsible Party): University of British Columbia

Tracking Information

• First Submitted Date: November 7, 2006
• First Posted Date: November 9, 2006
• Last Update Posted Date: September 18, 2014
• Study Start Date: November 2006
• Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 24, 2008): 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 ]
• Original Primary Outcome Measures (submitted: November 8, 2006): 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.

Current Secondary Outcome Measures (submitted: November 8, 2006)

• To determine the effects on cognition.
• To be measured at baseline and at the end of each treatment phase.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Cannabinoids in Bipolar Affective Disorder
• Official Title: Cannabinoids in Bipolar Affective Disorder: A Controlled Pilot Study
• Brief Summary: 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.
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Bipolar Affective Disorder

Intervention

Drug: Synthetic cannabinoids (1:1 ratio of THC % CBD)

Randomized crossover study of 2 weeks of active study medication (maximum daily dosage of 60 mg) vs. 2 weeks of matching placebo.

Study Arms

Experimental: Crossover

Intervention: Drug: Synthetic cannabinoids (1:1 ratio of THC % CBD)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: September 16, 2014): 0
• Original Enrollment (submitted: November 8, 2006): 50
• Estimated Study Completion Date: December 2013
• Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada
• Removed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00397605
• Other Study ID Numbers: H06-00239
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of British Columbia
• Original Responsible Party: Not Provided
• Current Study Sponsor: University of British Columbia
• Original Study Sponsor: Same as current
• Collaborators: Vancouver General Hospital

Investigators

• Principal Investigator: Allan H. Young, Ph.D; University of British Columbia

• PRS Account: University of British Columbia
• Verification Date: September 2014