Clinical trial NCT05457465: Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
Official title: Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Bipolar Disorder
Keywords: Cannabidiol
Lead sponsor: Mclean Hospital
Sponsor class: OTHER
First posted: 2022-07-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This investigation will be the first of its kind to conduct a clinical trial of an industrial hemp-derived high-CBD product in individuals with bipolar disorder who experience anxiety. Despite the recent interest in medical cannabis and cannabinoid-based products, the availability of hemp-derived products in all 50 states, and preliminary and anecdotal evidence suggesting that hemp-derived products may have a profound anxiolytic effect, along with potential antidepressant effects, no studies have conducted a clinical trial of a hemp-derived product in individuals with bipolar disorder who suffer from anxiety.

This investigation consists of a four-week open-label clinical trial of the custom formulated hemp-derived high-CBD solution. Participants will be pre-screened by phone in order to evaluate their eligibility for the study. If approved, potentially eligible participants will come to the hospital for a screening visit, and will complete a structured clinical interview, clinical and quality of life questionnaires, a urine screen, and a blood draw. Eligible participants will return for a baseline visit consisting of additional clinical and quality of life questionnaires, a brief cognitive assessment, and a buccal swab for genetic analysis. Participants will be given study product to use for the duration of the study, and will be instructed to self-administer the solution under the tongue twice daily for four weeks. Throughout the treatment period, participants will complete short in-person or remote visits on a weekly basis, where they will complete questionnaires about their mood and quality of life. Participants will also return to the hospital for a final visit after four weeks of treatment to complete additional questionnaires and cognitive assessments.

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

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

Primary outcomes:
measure: Change in self-reported ratings of anxiety on the Beck Anxiety Inventory (BAI)
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in self-reported ratings of depression on the Beck Depression Inventory (BDI)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
Study officials:
References: