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Taking people in United StatesPhase 2

Testing cannabidiol for anxiety and low mood in bipolar disorder

Tests a high-CBD product for 4 weeks in adults with bipolar disorder and anxiety.

Plain-language title generated from the registry record
Registry title: Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder

Key facts

Where
Belmont, United StatesSee the site
Phase
Phase 2

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Source: NCT05457465, who can take part

Where in United States

  • McLean HospitalBelmont, United StatesTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Mclean Hospital
Trial code
NCT05457465
Record updated
30 March 2026
Original description
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.Read full original descriptionShow less

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

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.

Inclusion: 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: Current use of valproate or divalproex; other concomitant medications may result in exclusion on a case-by-case basis; Current substance use disorder, current eating disorder, current or past psychotic disorder (e.g. schizophrenia, schizoaffective disorder); History of head injury/loss of consciousness >5 minutes; Presence of serious medical illness or neurological disorder; Allergy to palm oil; Not fluent in English; Estimated IQ <75; Endorsement of suicidality; Experiencing acute manic episode; Experiencing acute depressive episode; Current regular use of cannabinoid products; Pregnant or breastfeeding; Currently enrolled in another clinical trial that involves a treatment; Elevated LFTs at screening visit.

ClinicalTrials.gov NCT05457465