Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Hemp-Derived Cannabidiol Solution Patients will administer a custom-formulated, hemp-derived, high-CBD solution twice daily for 4 weeks |
Drug: Cannabidiol
Custom formulation of a hemp-derived, high-CBD product that contains no THC.
|
Outcome Measures
Primary Outcome Measures
- Change in self-reported ratings of anxiety on the Beck Anxiety Inventory (BAI) [4 weeks]
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).
Secondary Outcome Measures
- Change in self-reported ratings of depression on the Beck Depression Inventory (BDI) [4 weeks]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Provides informed consent
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Between the ages of 18-55
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Fluent in English
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Meets DSM-V criteria for bipolar disorder (type I or II)
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Experiences at least moderate levels of anxiety (as evidenced by self-reported rating scales)
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Is not currently experiencing greater than moderate levels of depression (evidenced by administered rating scales)
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On a stable pharmacotherapeutic regimen
Exclusion Criteria:
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Not fluent in English
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Estimated IQ <75
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Current or past substance use disorder or psychotic disorder; current eating disorder
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Endorsement of suicidality
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Experiencing acute manic episode
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History of head injury/loss of consciousness >5 minutes
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Current regular use of cannabinoid products
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Pregnant or breastfeeding
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Presence of serious medical illness or neurological disorder
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Current use of valproate or divalproex; other concomitant medications may result in exclusion on a case-by-case basis
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Currently enrolled in another clinical trial that involves a treatment
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Elevated LFTs at screening visit
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Mclean Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022P000825