Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
Recruiting · NCT05457465 · Interventional (participants receive a specific treatment) · Lead sponsor: Mclean Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 is running
1 location listed across 1 US state.
- McLean Hospital - Belmont, Massachusetts, United States