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

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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.

Conditions:

🦠 Bipolar Disorder

🗓️ Study Start (Actual) 1 June 2023

🗓️ Primary Completion (Estimated) June 2025

✅ Study Completion (Estimated) June 2025

👥 Enrollment (Estimated) 25

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE2

Locations:

📍 Belmont, Massachusetts, United States

📋 Eligibility Criteria

Description

Inclusion Criteria:

* Provides informed consent
* Between the ages of 18-55
* 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)
* Is not currently experiencing greater than moderate levels of depression (evidenced by administered rating scales)
* On a stable pharmacotherapeutic regimen

Exclusion Criteria:

* Not fluent in English
* Estimated IQ \<75
* Current or past substance use disorder or psychotic disorder; current eating disorder
* Endorsement of suicidality
* Experiencing acute manic 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
* 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

Ages Eligible for Study: 18 Years to 55 Years (ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 21 June 2022
First Submitted that Met QC Criteria 11 July 2022
First Posted 14 July 2022

Study Record Updates

Last Update Submitted that Met QC Criteria 7 March 2024
Last Update Posted 8 March 2024
Last Verified March 2024