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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Cannabidiol
  Custom formulation of a hemp-derived, high-CBD product that contains no THC.

Первичные конечные точки

• Change in self-reported ratings of anxiety on the Beck Anxiety Inventory (BAI) [Срок оценки: 4 weeks]

Вторичные конечные точки (1)

• Change in self-reported ratings of depression on the Beck Depression Inventory (BDI) [Срок оценки: 4 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• McLean Hospital — Belmont

Идентификаторы

NCT: NCT05457465 · 2022P000825

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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