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

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.

Study Overview

• Status: Recruiting
• Conditions: Bipolar Disorder
• Intervention / Treatment: Drug: Cannabidiol

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 Type: Interventional
• Enrollment (Estimated): 25
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Rosemary Smith, B.S.; Phone Number: 617-855-3338; Email: CBDstudy@mclean.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • Recruiting
      • McLean Hospital
      • Contact: Rosemary Smith, B.S.; Phone Number: 617-855-3338; Email: CBDstudy@mclean.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemp-Derived Cannabidiol Solution; Patients will administer a custom-formulated, hemp-derived, high-CBD solution twice daily for 4 weeks	Drug: Cannabidiol; Custom formulation of a hemp-derived, high-CBD product that contains no THC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mclean Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: June 21, 2022
• First Submitted That Met QC Criteria: July 11, 2022
• First Posted (Actual): July 14, 2022

Study Record Updates

• Last Update Posted (Actual): March 8, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Cannabidiol
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Bipolar and Related Disorders; Bipolar Disorder; Anticonvulsants; Cannabidiol
• Other Study ID Numbers: 2022P000825

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No