RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-06-01
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05457465

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Provides informed consent
  2. * Between the ages of 18-55
  3. * Fluent in English
  4. * Meets DSM-5 criteria for bipolar disorder (type I or II)
  5. * Experiences at least moderate levels of anxiety (as evidenced by self-reported rating scales)
  6. * Is not currently experiencing greater than moderate levels of depression (evidenced by administered rating scales)
  7. * On a stable pharmacotherapeutic regimen
  1. * Not fluent in English
  2. * Estimated IQ \<75
  3. * Current or past substance use disorder or psychotic disorder; current eating disorder
  4. * Endorsement of suicidality
  5. * Experiencing acute manic episode
  6. * History of head injury/loss of consciousness \>5 minutes
  7. * Current regular use of cannabinoid products
  8. * Pregnant or breastfeeding
  9. * Presence of serious medical illness or neurological disorder
  10. * Current use of valproate or divalproex; other concomitant medications may result in exclusion on a case-by-case basis
  11. * Currently enrolled in another clinical trial that involves a treatment
  12. * Elevated LFTs at screening visit

Contacts and Locations

Study Contact

Rosemary Smith, B.S.
CONTACT
617-855-3338
CBDstudy@mclean.harvard.edu

Study Locations (Sites)

McLean Hospital
Belmont, Massachusetts, 02478
United States

Collaborators and Investigators

Sponsor: Mclean Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-01
Study Completion Date2025-06

Study Record Updates

Study Start Date2023-06-01
Study Completion Date2025-06

Terms related to this study

Keywords Provided by Researchers

  • Cannabidiol

Additional Relevant MeSH Terms

  • Bipolar Disorder