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

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.

Conditions

Bipolar Disorder

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Bipolar Disorder
Intervention / Treatment

-

Contacts and Locations

Belmont

McLean Hospital, Belmont, Massachusetts, United States, 02478

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 55 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Mclean Hospital,

Study Record Dates

2025-06