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

Bipolar Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05457465
• Other study ID #: 2022P000825
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2023
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Mclean Hospital
• Contact: Rosemary Smith, B.S.
• Phone: 617-855-3338
• Email: CBDstudy[@]mclean.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

Drug:
• Cannabidiol
Custom formulation of a hemp-derived, high-CBD product that contains no THC.

Locations

Country	Name	City	State
United States	McLean Hospital	Belmont	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mclean Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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