NCT00397605

Cannabinoids in Bipolar Affective Disorder

Cannabinoids in Bipolar Affective Disorder: A Controlled Pilot Study

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of British Columbia · Academic / Other
• Sex: All
• Age: 19 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bipolar Affective Disorder

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2006-11-01
• Primary completion: 2013-12-01
• Completion: 2013-12-01
• First posted: 2006-11-09
• Last updated: 2014-09-18

Locations

1 site across 1 country: Canada