Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
Mclean Hospital
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.
Description
This investigation will be the first of its kind to conduct a clinical trial of an industrial hemp-derived high-CBD product in individuals with bipolar disorder who experience anxiety. Despite the recent interest in medical cannabis and cannabinoid-based products, the availability of hemp-derived products in all 50 states, and preliminary and anecdotal evidence suggesting that hemp-derived products may have a profound anxiolytic effect, along with potential antidepressant effects, no studies have conducted a clinical trial of a hemp-derived product in individuals with bipolar disorder who suff…
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 epi…
Interventions
- DrugCannabidiol
Custom formulation of a hemp-derived, high-CBD product that contains no THC.
Location
- McLean HospitalBelmont, Massachusetts