Epidiolex in Obsessive Compulsive Disorder and Related Disorders
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|ClinicalTrials.gov Identifier: NCT04978428|
Recruitment Status : Recruiting
First Posted : July 27, 2021
Last Update Posted : July 5, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Obsessive-Compulsive Disorder Trichotillomania (Hair-Pulling Disorder) Tourette Syndrome Hoarding Disorder||Drug: Cannabidiol||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Open-Label treatment study|
|Masking:||None (Open Label)|
|Official Title:||An Open-Label Trial of Epidiolex in the Treatment of Obsessive Compulsive Disorder and Related Disorders: Proof of Concept Study|
|Actual Study Start Date :||April 14, 2022|
|Estimated Primary Completion Date :||September 2023|
|Estimated Study Completion Date :||September 2023|
Epidiolex (2.5 mg/kg twice daily for one week) followed by Epidiolex (5mg/kg twice daily for two weeks)
Epidiolex oral solution (2.5 mg/kg and 5 mg/kg)
Other Name: Epidiolex
- Yale Brown Obsessive Compulsive Scale (YBOCS) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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.
- Clinical Global Impressions- Improvement Scale (CGI-I) [ Time Frame: Baseline to Week 2 ]The entire study for the subject will last 8 weeks. Every week the subject will complete the CGI. The change in scores from baseline to after 8 weeks will be assessed. The scale itself assesses overall disorder severity on a scale from 1 to 7 with 1 being "not at all" and 7 being "among the most severe cases"
- Hamilton Depression Rating Scale (HAM-D) [ Time Frame: Baseline to Week 2 ]A clinician-administered assessment of depression that will be assessed at all study visits. Higher total scores indicate higher levels of depression, while a score of 0 would indicate no depressive symptoms.
- Hamilton Anxiety Rating Scale (HAM-A) [ Time Frame: Baseline to Week 2 ]A clinician-administered assessment of anxiety that will be assessed at all study visits. Changes in scores from baseline to final visit will be assessed. Higher scores indicate higher levels of anxiety, with 0 being no symptoms of anxiety.
- Sheehan Disability Scale (SDS) [ Time Frame: Baseline to Week 2 ]Subjects will complete the SDS at all visits. The change in scores from baseline to study completion will be assessed. The scale itself assesses the level of disability from target disorder with higher scores indicating a more debilitating disorder.
- Quality of Life Inventory (QOLI) [ Time Frame: Baseline to Week 2 ]A self-report assessment of patient perceived quality of life that will be assessed at baseline and week 8. Higher scores indicate a higher quality of life, whereas lower scores indicate a lower quality of life.
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|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04978428
|Contact: Eve K Chesivoir, BAfirstname.lastname@example.org|
|Contact: Stephanie Valle, BA||(773) email@example.com|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Eve K Chesivoir, BA 773-702-9066 firstname.lastname@example.org|
|Contact: Stephanie Valle, BA (773) 834-3778 email@example.com|
|Principal Investigator: Jon E Grant, MD, JD, MPH|
|Principal Investigator:||Jon E Grant, MD, JD, MPH||University of Chicago|
|Responsible Party:||University of Chicago|
|Other Study ID Numbers:||
|First Posted:||July 27, 2021 Key Record Dates|
|Last Update Posted:||July 5, 2022|
|Last Verified:||June 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Obsessive Compulsive Disorder
Skin Picking Disorder
Body focused repetitive behaviors
Compulsive Personality Disorder
Basal Ganglia Diseases
Central Nervous System Diseases
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Genetic Diseases, Inborn
Disruptive, Impulse Control, and Conduct Disorders