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

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mclean Hospital
• Treatments: Cannabidiol

Criteria

Inclusion Criteria:

• Provides informed consent

• Between the ages of 18-55

• Fluent in English

• Meets DSM-V 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