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Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
RECRUITINGPhase 2Sponsored by Mclean Hospital
Actively Recruiting
PhasePhase 2
SponsorMclean Hospital
Started2023-06-01
Est. completion2025-12
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05457465
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.
Eligibility
Age: 18 Years – 65 YearsHealthy volunteers accepted
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
Conditions3
AnxietyBipolar DisorderDepression
Locations1 site
McLean Hospital
Belmont, Massachusetts, 02478
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Actively Recruiting
PhasePhase 2
SponsorMclean Hospital
Started2023-06-01
Est. completion2025-12
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →
NCT05457465