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Cannabinoids in Bipolar Affective Disorder

Primary Purpose

Bipolar Affective Disorder

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Synthetic cannabinoids (1:1 ratio of THC % CBD)
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Affective Disorder focused on measuring bipolar, therapeutic potential, neurocognitive performance, cannabinoids

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Psychiatry, University of British Columbia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Crossover

Arm Description

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 7, 2006
Last Updated
September 16, 2014
Sponsor
University of British Columbia
Collaborators
Vancouver General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00397605
Brief Title
Cannabinoids in Bipolar Affective Disorder
Official Title
Cannabinoids in Bipolar Affective Disorder: A Controlled Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Withdrawn
Why Stopped
study was never started and no patients were ever enrolled
Study Start Date
November 2006 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of British Columbia
Collaborators
Vancouver General Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Affective Disorder
Keywords
bipolar, therapeutic potential, neurocognitive performance, cannabinoids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Crossover
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Synthetic cannabinoids (1:1 ratio of THC % CBD)
Intervention Description
Randomized crossover study of 2 weeks of active study medication (maximum daily dosage of 60 mg) vs. 2 weeks of matching placebo.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
To determine the effects on cognition.
Title
To be measured at baseline and at the end of each treatment phase.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan H. Young, Ph.D
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2A1
Country
Canada

12. IPD Sharing Statement

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Cannabinoids in Bipolar Affective Disorder

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