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

NCT ID: NCT05457465

Last Updated: 2025-03-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-01
• Study Completion Date: 2025-12-31

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.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hemp-Derived Cannabidiol Solution

Patients will administer a custom-formulated, hemp-derived, high-CBD solution twice daily for 4 weeks

Group Type: EXPERIMENTAL

Cannabidiol

Intervention Type: DRUG

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

Interventions

Cannabidiol

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mclean Hospital

OTHER

Sponsor Role: lead

Responsible Party

Staci Gruber, Ph.D.

Director, Marijuana Investigations for Neuroscientific Discovery; Director, Cognitive and Clinical Neuroimaging Core

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

McLean Hospital

Belmont, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Rosemary Smith, B.S.

Role: CONTACT

CBDstudy@mclean.harvard.edu

617-855-3338

Facility Contacts

Rosemary Smith, B.S.

Role: primary

CBDstudy@mclean.harvard.edu

617-855-3338

Other Identifiers

2022P000825

Identifier Type: -

Identifier Source: org_study_id