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Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder

RecruitingPhase 2Ages 18 Years - 65 YearsAllMclean Hospital
NCT05457465 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Cannabidiol
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Where

1 site
McLean Hospital
Belmont, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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