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.
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 2010 |
| Estimated Primary Completion Date: |
December 2010 (Final data collection date for primary outcome measure) |
|
Crossover: Experimental
|
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.
|
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.
Purpose
