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

Last updated: March 14, 2025
Sponsor: Mclean Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Bipolar Disorder

Mood Disorders

Treatment

Cannabidiol

Clinical Study ID

NCT05457465
2022P000825
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provides informed consent

  • Between the ages of 18-65

  • 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-reportedrating scales)

  • On a stable pharmacotherapeutic regimen

Exclusion

Exclusion Criteria:

  • Not fluent in English

  • Estimated IQ <75

  • Current substance use disorder, current eating disorder, current or past psychoticdisorder (e.g. schizophrenia, schizoaffective disorder)

  • Endorsement of suicidality

  • Experiencing acute manic episode

  • Experiencing acute depressive 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

  • Allergy to palm oil

  • Current use of valproate or divalproex; other concomitant medications may result inexclusion on a case-by-case basis

  • Currently enrolled in another clinical trial that involves a treatment

  • Elevated LFTs at screening visit

Study Design

Total Participants: 25
Treatment Group(s): 1
Primary Treatment: Cannabidiol
Phase: 2
Study Start date:
June 01, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • McLean Hospital

    Belmont, Massachusetts 02478
    United States

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.