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Cannabinoids in Bipolar Affective Disorder

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ClinicalTrials.gov Identifier: NCT00397605
Recruitment Status : Withdrawn (study was never started and no patients were ever enrolled)
First Posted : November 9, 2006
Last Update Posted : September 18, 2014
Sponsor:
Collaborator:
Vancouver General Hospital
Information provided by (Responsible Party):
University of British Columbia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bipolar Affective Disorder Drug: Synthetic cannabinoids (1:1 ratio of THC % CBD) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Cannabinoids in Bipolar Affective Disorder: A Controlled Pilot Study
Study Start Date : November 2006
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  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. [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. To determine the effects on cognition.
  2. To be measured at baseline and at the end of each treatment phase.

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00397605


Locations
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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
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Principal Investigator: Allan H. Young, Ph.D University of British Columbia
More Information
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Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00397605    
Other Study ID Numbers: H06-00239
First Posted: November 9, 2006    Key Record Dates
Last Update Posted: September 18, 2014
Last Verified: September 2014
Keywords provided by University of British Columbia:
bipolar
therapeutic potential
neurocognitive performance
cannabinoids
Additional relevant MeSH terms:
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Genetic Diseases, X-Linked
Mood Disorders
Bipolar Disorder
 Mental Disorders
Bipolar and Related Disorders
Genetic Diseases, Inborn