Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder

Study Overview
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Brief Summary
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Preliminary data have suggested that cannabidiol (CBD) may have a number of clinical benefits, including anti-anxiety and antidepressant properties. This study is a pilot open-label clinical trial assessing a custom-formulated high-CBD product over the course of 4 weeks in patients with bipolar disorder who experience anxiety.

Detailed Description
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This investigation will be the first of its kind to conduct a clinical trial of an industrial hemp-derived high-CBD product in individuals with bipolar disorder who experience anxiety. Despite the recent interest in medical cannabis and cannabinoid-based products, the availability of hemp-derived products in all 50 states, and preliminary and anecdotal evidence suggesting that hemp-derived products may have a profound anxiolytic effect, along with potential antidepressant effects, no studies have conducted a clinical trial of a hemp-derived product in individuals with bipolar disorder who suffer from anxiety. This investigation consists of a four-week open-label clinical trial of the custom formulated hemp-derived high-CBD solution. Participants will be pre-screened by phone in order to evaluate their eligibility for the study. If approved, potentially eligible participants will come to the hospital for a screening visit, and will complete a structured clinical interview, clinical and quality of life questionnaires, a urine screen, and a blood draw. Eligible participants will return for a baseline visit consisting of additional clinical and quality of life questionnaires, a brief cognitive assessment, and a buccal swab for genetic analysis. Participants will be given study product to use for the duration of the study, and will be instructed to self-administer the solution under the tongue twice daily for four weeks. Throughout the treatment period, participants will complete short in-person or remote visits on a weekly basis, where they will complete questionnaires about their mood and quality of life. Participants will also return to the hospital for a final visit after four weeks of treatment to complete additional questionnaires and cognitive assessments.

Official Title
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Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder

Conditions
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Bipolar Disorder

Intervention / Treatment
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* Drug: Cannabidiol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provides informed consent Between the ages of 18-55 Fluent in English Meets DSM-5 criteria for bipolar disorder (type I or II) Experiences at least moderate levels of anxiety (as evidenced by self-reported rating scales) Is not currently experiencing greater than moderate levels of depression (evidenced by administered rating scales) On a stable pharmacotherapeutic regimen Exclusion Criteria: Not fluent in English Estimated IQ <75 Current or past substance use disorder or psychotic disorder; current eating disorder Endorsement of suicidality Experiencing acute manic episode History of head injury/loss of consciousness >5 minutes Current regular use of cannabinoid products Pregnant or breastfeeding Presence of serious medical illness or neurological disorder Current use of valproate or divalproex; other concomitant medications may result in exclusion on a case-by-case basis Currently enrolled in another clinical trial that involves a treatment Elevated LFTs at screening visit

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemp-Derived Cannabidiol Solution<br>Patients will administer a custom-formulated, hemp-derived, high-CBD solution twice daily for 4 weeks | Drug: Cannabidiol<br>* Custom formulation of a hemp-derived, high-CBD product that contains no THC.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported ratings of anxiety on the Beck Anxiety Inventory (BAI) | Anxiety will be assessed using a number of self-report and administered clinical ratings scales: the primary outcome measure will be the Beck Anxiety Inventory (BAI), which is a 21-item self-report measure used to rate subjective, somatic, and panic-related symptoms of anxiety on a scale of 0 (not at all) to 3 (severely). The total score ranges from 0 (no anxiety) to 63 (severe anxiety). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported ratings of depression on the Beck Depression Inventory (BDI) | Depressive symptoms will be assessed using the Beck Depression Inventory (BDI), which is a 21-item self-report measure used to rate symptoms of depression on a scale of 0 (none) to 3 (very much). The total score ranges from 0 (no depressive symptoms) to 63 (severe depressive symptoms). | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabidiol