Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder
ID: NCT05457465
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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.
Read Full Scientific Objectives & Methods
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.
Custom formulation of a hemp-derived, high-CBD product that contains no THC.
Treatment Arms Description
Patients will administer a custom-formulated, hemp-derived, high-CBD solution twice daily for 4 weeks
- 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
- 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
- Currently enrolled in another clinical trial that involves a treatment
- Elevated LFTs at screening visit
Primary Outcome Measures
- Change in self-reported ratings of anxiety on the Beck Anxiety Inventory (BAI) — Time Frame: 4 weeks
Anxiety will be assessed using a number of self-report and administered clinical ratings scales: the primary outcome measure will be the Beck Anxiety Inventory (BAI), which is a 21-item self-report measure used to rate subjective, somatic, and panic-related symptoms of anxiety on a scale of 0 (not at all) to 3 (severely). The total score ranges from 0 (no anxiety) to 63 (severe anxiety).
View Secondary Outcome Measures (1)
- Change in self-reported ratings of depression on the Beck Depression Inventory (BDI) — Time Frame: 4 weeks
Depressive symptoms will be assessed using the Beck Depression Inventory (BDI), which is a 21-item self-report measure used to rate symptoms of depression on a scale of 0 (none) to 3 (very much). The total score ranges from 0 (no depressive symptoms) to 63 (severe depressive symptoms).
This trial is recruiting at 1 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:
Show All 1 Facilities & Contact Sites
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View Official Medical/Scientific Title
Assessing the Impact of Cannabidiol for Anxiety and Depression in Bipolar Disorder