assessing the impact of cannabidiol for anxiety and depression in bipolar disorder

Conditions: Bipolar Disorder

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.

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

Keywords: cannabidiol