Cannabinoids in Bipolar Affective Disorder

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cannabinoids in Bipolar Affective Disorder: A Controlled Pilot Study

Conditions
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Bipolar Affective Disorder

Intervention / Treatment
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* Drug: Synthetic cannabinoids (1:1 ratio of THC % CBD)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crossover<br> | Drug: Synthetic cannabinoids (1:1 ratio of THC % CBD)<br>* Randomized crossover study of 2 weeks of active study medication (maximum daily dosage of 60 mg) vs. 2 weeks of matching placebo.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the effects on cognition. |  |  | 
| To be measured at baseline and at the end of each treatment phase. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bipolar, therapeutic potential, neurocognitive performance, cannabinoids