Home › Bipolar Disorder › NCT05457465
Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
RecruitingPhase 2
Who can join
Ages 18 to 65 · All sexes
Full eligibility 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
About the 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.
What is being tested
- Cannabidiol (drug)
Sponsor: Mclean Hospital · Participants: 25 · Started: Jun 1, 2023
Contact the study team
- Rosemary Smith, B.S. · Phone: 617-855-3338
Official record on ClinicalTrials.gov — NCT05457465
Locations in the U.S.
| Massachusetts | McLean Hospital, Belmont |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.