Cannabinoids in Bipolar Affective Disorder

NCT ID: NCT00397605

Last Updated: 2014-09-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2013-12-31

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.

Conditions

Bipolar Affective Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Crossover

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

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.

• 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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vancouver General Hospital

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Allan H. Young, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Department of Psychiatry, University of British Columbia

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

H06-00239

Identifier Type: -

Identifier Source: org_study_id