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

Recruiting now · Phase 2

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT05457465

Run by

Mclean Hospital

People needed

25

Starts

2023-06-01

Expected to finish

2026-12-01

Last updated by the study team

2026-03-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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
• 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 is running

• McLean Hospital — Belmont, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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