Cannabinoids in Bipolar Affective Disorder

NCT00397605 | Withdrawn

• 1 other identifier: H06-00239
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Affective Disorder

Keywords

bipolar; therapeutic potential; neurocognitive performance; cannabinoids

Outcome Measures

Primary Outcomes (1)

• 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.

  13 weeks

Secondary Outcomes (2)

• To determine the effects on cognition.

• To be measured at baseline and at the end of each treatment phase.

Study Arms (1)

Crossover

EXPERIMENTAL

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

Interventions

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

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

Crossover

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of British Columbia: lead
• Vancouver General Hospital: collaborator

Study Sites (1)

Department of Psychiatry, University of British Columbia

Vancouver, British Columbia, V6T 2A1, Canada

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Allan H. Young, Ph.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2006
• First Posted: November 9, 2006
• Study Start: November 1, 2006
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: September 18, 2014

Record last verified: 2014-09

Locations

CA (1)