Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
Recruiting
Phase 2Interventional Study
Bipolar Disorder
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
25 (estimated)
Sponsor
Mclean Hospital · Other
Who this trial is looking for
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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.
Trial Locations
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Status
Eligibility Criteria
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
Exclu…
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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