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

NCT05457465 | Recruiting Phase 2 FDA Drug

• 1 other identifier: 2022P000825
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

Cannabidiol

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in self-reported ratings of depression on the Beck Depression Inventory (BDI)

  4 weeks

Study Arms (1)

Hemp-Derived Cannabidiol Solution

EXPERIMENTAL

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

Drug: Cannabidiol

Interventions

Cannabidiol DRUG

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

Hemp-Derived Cannabidiol Solution

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Currently enrolled in another clinical trial that involves a treatment
• Elevated LFTs at screening visit

Sponsors & Collaborators

• Mclean Hospital: lead

Study Sites (1)

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Rosemary Smith, B.S.

CONTACT

617-855-3338; CBDstudy@mclean.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Marijuana Investigations for Neuroscientific Discovery; Director, Cognitive and Clinical Neuroimaging Core

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: July 14, 2022
• Study Start: June 1, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

US (1)