Recruiting
Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
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.
ClinicalTrials.gov IDNCT05457465
PhasePHASE2
Enrollment25
SponsorMclean Hospital
Age18 Years – 65 Years
SexALL
Conditions studied
Bipolar Disorder
About this study
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.
Interventions
- Drug: Cannabidiol — Custom formulation of a hemp-derived, high-CBD product that contains no THC.
Primary outcomes
- Change in self-reported ratings of anxiety on the Beck Anxiety Inventory (BAI) (4 weeks)
Eligibility information
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
Study locations
- McLean Hospital, Belmont, Massachusetts 02478 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-22.