Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
Purpose
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
- Bipolar Disorder
Eligibility
- Eligible Ages
- Between 18 Years and 55 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Hemp-Derived Cannabidiol Solution |
Patients will administer a custom-formulated, hemp-derived, high-CBD solution twice daily for 4 weeks |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Mclean Hospital
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.
