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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.
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.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Bipolar Affective Disorder
Synthetic cannabinoids (1:1 ratio of THC % CBD)
Department of Psychiatry, University of British Columbia
Active, not recruiting
University of British Columbia
Published on BioPortfolio: 2014-08-27T03:41:39-0400
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A major affective disorder marked by severe mood swings (manic or major depressive episodes) and a tendency to remission and recurrence.
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