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

Phase 2

Recruiting

• Conditions: Bipolar Disorder
• Interventions: Drug: Cannabidiol

• Registration Number: NCT05457465
• Lead Sponsor: Mclean Hospital

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.

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 Timeline

• Study First Submitted: 2022-06-21
• Study First Submitted QC: 2022-07-11
• Study First Posted: 2022-07-14
• Study Start: 2023-06-01
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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-reported rating scales)
• On a stable pharmacotherapeutic regimen

Exclusion Criteria

• Not fluent in English
• Estimated IQ <75
• Current substance use disorder, current eating disorder, current or past psychotic disorder (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 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hemp-Derived Cannabidiol Solution	Cannabidiol	Patients will administer a custom-formulated, hemp-derived, high-CBD solution twice daily for 4 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).

Trial Locations

Locations (1)

McLean Hospital; 🇺🇸 Belmont, Massachusetts, United States