Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT05457465

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

Led by Mclean Hospital · Updated on 2026-03-30

25

Participants Needed

1

Research Sites

182 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Not fluent in English
  • Estimated IQ less than 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 longer than 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 liver function tests at screening visit

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

McLean Hospital

Belmont, Massachusetts, United States, 02478

Actively Recruiting

Loading map...

Research Team

R

Rosemary Smith, B.S.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here