Cannabinoids in Bipolar Affective Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Vancouver General Hospital
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00397605
First received: November 7, 2006
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Bipolar Affective Disorder
Drug: Synthetic cannabinoids (1:1 ratio of THC % CBD)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Cannabinoids in Bipolar Affective Disorder: A Controlled Pilot Study

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the effects on cognition. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
  • To be measured at baseline and at the end of each treatment phase. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Crossover 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.

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.

  Eligibility

Ages Eligible for Study:   19 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397605

Locations
Canada, British Columbia
Department of Psychiatry, University of British Columbia
Vancouver, British Columbia, Canada, V6T 2A1
Sponsors and Collaborators
University of British Columbia
Vancouver General Hospital
Investigators
Principal Investigator: Allan H. Young, Ph.D University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00397605     History of Changes
Other Study ID Numbers: H06-00239
Study First Received: November 7, 2006
Last Updated: January 16, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
bipolar
therapeutic potential
neurocognitive performance
cannabinoids

Additional relevant MeSH terms:
Bipolar Disorder
Genetic Diseases, X-Linked
Mood Disorders
Affective Disorders, Psychotic
Mental Disorders
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on August 28, 2014