RecruitingPhase 2NCT05457465

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

Sponsor

Mclean Hospital

Enrollment

25 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

Bipolar Disorder

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria6

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 Criteria14

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