Using cannabidiol to treat anxiety and depression in bipolar disorder
Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
This study is testing if a special CBD product can help people with bipolar disorder who also struggle with anxiety and depression feel better over four weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Mclean Hospital Academic / other |
| Locations | 1 site (Belmont, Massachusetts) |
| Trial ID | NCT05457465 on ClinicalTrials.gov |
What this trial studies
This pilot open-label clinical trial investigates the effects of a custom-formulated high-CBD product on patients with bipolar disorder who experience anxiety. Over a four-week period, participants will self-administer the CBD solution twice daily while undergoing assessments to evaluate their mental health and quality of life. The study aims to gather preliminary data on the anxiolytic and antidepressant properties of hemp-derived cannabidiol in this specific patient population. Participants will be carefully screened to ensure they meet eligibility criteria before starting the treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a diagnosis of bipolar disorder who experience moderate to severe anxiety.
Not a fit: Patients currently experiencing acute manic or depressive episodes, or those with a history of substance use disorders, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel therapeutic option for managing anxiety and depression in individuals with bipolar disorder.
How similar studies have performed: While there is growing interest in cannabinoid-based treatments, this specific approach has not been previously tested in individuals with bipolar disorder, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Belmont, Massachusetts
- McLean Hospital — Belmont, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Rosemary Smith, B.S.
- Email: CBDstudy@mclean.harvard.edu
- Phone: 617-855-3338
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.