NCT05457465RecruitingPhase 2
Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 25 (estimated)
- First submitted
- 21 Jun 2022
- Start date
- Jun 2023
- Primary completion date
- Dec 2026
- Lead sponsor
- Mclean Hospital
- Diseases
- Bipolar disorder
- NCT number
- NCT05457465
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 25
- From Jun 2023 to the primary completion date, Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of valproate or divalproex; other concomitant medications may result in exclusion on a case-by-case basis
Other illness
- Current substance use disorder, current eating disorder, current or past psychotic disorder (e.g. schizophrenia, schizoaffective disorder)
- History of head injury/loss of consciousness \>5 minutes
- Presence of serious medical illness or neurological disorder
- Allergy to palm oil
Other
- Not fluent in English
- Estimated IQ \<75
- Endorsement of suicidality
- Experiencing acute manic episode
- Experiencing acute depressive episode
- Current regular use of cannabinoid products
- Pregnant or breastfeeding
- Currently enrolled in another clinical trial that involves a treatment
- Elevated LFTs at screening visit
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| McLean Hospital Coordinator of this site? Confirm its status | Belmont | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.