An Open-Label Trial of Epidiolex in the Treatment of Obsessive Compulsive Disorder and Related Disorders: Proof of Concept Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Yale Brown Obsessive Compulsive Scale (YBOCS)
研究概览
简要总结
The primary objective of the proposed study is to evaluate the safety and efficacy of Epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (OCRDs). Subjects will be treated in an open-label fashion with Epidiolex for two weeks.
详细描述
The primary objective of the proposed study is to evaluate the safety and efficacy of Epidiolex (cannabidiol) in adults with obsessive compulsive and related disorders (OCRDs). OCRDs include obsessive compulsive disorder (OCD), trichotillomania, skin picking, tourettes disorder, and hoarding disorders. These disorders appear linked in terms of phenomenology and possibly biology. Fifteen subjects with OCRDs will be treated in an open-label fashion with Epidiolex (2.5 mg/kg twice daily for one week followed by 5mg/kg twice daily) for two total weeks of active treatment. The hypothesis to be tested is that Epidiolex will result in reduction in symptoms of OCRDs (improvement in symptoms will be indicated by lower scores on established outcome measures of OCRDs symptoms that have been used in prior studies).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women age 18-65
- •Primary diagnosis of OCD, Hoarding Disorder, Skin Picking Disorder, Trichotillomania, or Tourette Syndrome
- •YBOCS score of at least 18 at baseline
- •Ability to understand and sign the consent form.
排除标准
- •Unstable medical illness based on history or clinically significant abnormalities on baseline physical examination or labs
- •Current pregnancy or lactation, or inadequate contraception in women of childbearing potential
- •Subjects considered an immediate suicide risk based on the Columbia Suicide Severity Rating Scale (C-SSRS)
- •Past 12-month DSM-5 psychiatric disorder other than OCD
- •Illegal substance use based on urine toxicology screening
- •Initiation of psychological interventions within 3 months of screening
- •Use of any other psychotropic medication
- •Previous treatment with Epidiolex
- •Cognitive impairment that interferes with the capacity to understand and self-administer medication or provide written informed consent
研究组 & 干预措施
Epidiolex
Epidiolex (2.5 mg/kg twice daily for one week) followed by Epidiolex (5mg/kg twice daily for two weeks)
干预措施: Cannabidiol (Drug)
结局指标
主要结局
Yale Brown Obsessive Compulsive Scale (YBOCS)
时间窗: Baseline to Week 2
The primary outcome measure will be the change from baseline using the Yale Brown Obsessive Compulsive Scale (YBOCS). The YBOCS is a 10-item scale that assesses OCD symptoms during the last seven days. The first five items comprise the urge/thought subscale and items 6-10 comprise the behavior subscale.
NIMH Symptom Severity Scale (for TTM or Skin Picking)
时间窗: Baseline to Week 2
The primary efficacy measure will be the change in hair pulling or skin picking frequency and urges to pull hair or pick skin for the past week as indicated by change in total score. The entire study lasts 10 weeks. Every two weeks subjects will take the NIMH-TSS. The change in scores from baseline to after 10 weeks will be assessed. The scale itself assesses severity of trichotillomania symptoms. The NIMH-TSS score ranges from 0 to 20, with 0 being no symptoms and 20 being the most severe.
The Hoarding Rating Scale (HRS)
时间窗: Baseline to Week 2
The Hoarding Rating Scale is a brief, clinician rated 5-item scale This tool includes 5 questions about clutter, difficulty discarding, excessive acquisition, and the resulting distress and impairment caused by hoarding. Initial studies suggest that a score of 14 or higher on the HRS indicates a probable hoarding problem/Hoarding Disorder diagnosis.
Yale Global Tic Severity Scale (YGTSS)
时间窗: Baseline to Week 2
The Yale Global Tic Severity Scale is a semi-structured clinical interview and currently the gold standard for assessing the severity of tics in children and adults. The YGTSS enables evaluations of number, frequency, intensity, complexity, and interference of motor and phonic tics, covering the past week. Each domain is scored on a 6-point scale (range 0-5) with a separate rating for "overall impairment" regarding the subject's daily life and activities (4). Five sum scores can be created: the total motor tic score (range 0-25), the total phonic tic score (range 0-25), the total tic score (TTS; sum of the total motor tic score plus the total phonic tic score), the overall impairment rating (one item; range 0-50), and the global severity score (GSS; sum of the TTS plus the overall impairment rating, range 0-100). Higher scores reflect worse severity and worse impairment.
Change in Yale Brown Obsessive Compulsive Scale (YBOCS) Total Score
时间窗: Baseline to Week 2
The primary outcome measure will be the change from baseline using the Yale Brown Obsessive Compulsive Scale (YBOCS). The YBOCS is a 10-item scale that assesses OCD symptoms during the last seven days. The first five items comprise the urge/thought subscale and items 6-10 comprise the behavior subscale. The change in scores from baseline to Week 2 will be reported. The scores from the subscales are summed together to reach a total score. The scale ranges from 0-40 with higher scores reflecting more severe symptoms.
Change in NIMH Symptom Severity Scale (for TTM or Skin Picking) Total Score
时间窗: Baseline to Week 2
The primary efficacy measure will be the change in hair pulling or skin picking frequency and urges to pull hair or pick skin for the past week as indicated by change in total score. The entire study lasts two weeks. Every two weeks subjects will take the NIMH-TSS. The change in scores from baseline to Week 2 will be reported. The scale itself assesses severity of trichotillomania symptoms. The NIMH-TSS score ranges from 0 to 20, with 0 being no symptoms and 20 being the most severe.
次要结局
- Hamilton Depression Rating Scale (HAM-D)(Baseline to Week 2)
- Clinical Global Impressions- Improvement Scale (CGI-I)(Baseline to Week 2)
- Hamilton Anxiety Rating Scale (HAM-A)(Baseline to Week 2)
- Sheehan Disability Scale (SDS)(Baseline to Week 2)
- Quality of Life Inventory (QOLI)(Baseline to Week 2)
- Change in Clinical Global Impressions- Severity Scale (CGI-S) Total Score(Baseline to Week 2)
- Change in Hamilton Depression Rating Scale (HAM-D) Total Score(Baseline to Week 2)
- Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score(Baseline to Week 2)
- Change in Sheehan Disability Scale (SDS) Total Score(Baseline to Week 2)
- Change in Quality of Life Inventory (QOLI) Total Score(Baseline to Week 2)