Using cannabidiol to treat anxiety and depression in bipolar disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot open-label clinical trial investigates the effects of a custom-formulated high-CBD product on patients with bipolar disorder who experience anxiety. Over a four-week period, participants will self-administer the CBD solution twice daily while undergoing assessments to evaluate their mental health and quality of life. The study aims to gather preliminary data on the anxiolytic and antidepressant properties of hemp-derived cannabidiol in this specific patient population. Participants will be carefully screened to ensure they meet eligibility criteria before starting the treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Where it's running

• McLean Hospital
  Belmont, Massachusetts, United States Recruiting

Study contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.