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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidiolex | Experimental | Epidiolex (2.5 mg/kg twice daily for one week) followed by Epidiolex (5mg/kg twice daily for two weeks) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol | Drug | Epidiolex oral solution (2.5 mg/kg and 5 mg/kg) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Yale Brown Obsessive Compulsive Scale (YBOCS) | 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. | Baseline to Week 2 |
| NIMH Symptom Severity Scale (for TTM or Skin Picking) | 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. | Baseline to Week 2 |
| The Hoarding Rating Scale (HRS) | 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. | Baseline to Week 2 |
| Yale Global Tic Severity Scale (YGTSS) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Global Impressions- Improvement Scale (CGI-I) | 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" | Baseline to Week 2 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jon E Grant, MD, JD, MPH | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16848654 | Background | Blanco C, Olfson M, Stein DJ, Simpson HB, Gameroff MJ, Narrow WH. Treatment of obsessive-compulsive disorder by U.S. psychiatrists. J Clin Psychiatry. 2006 Jun;67(6):946-51. doi: 10.4088/jcp.v67n0611. | |
| 16585942 | Background | Bloch MH, Landeros-Weisenberger A, Kelmendi B, Coric V, Bracken MB, Leckman JF. A systematic review: antipsychotic augmentation with treatment refractory obsessive-compulsive disorder. Mol Psychiatry. 2006 Jul;11(7):622-32. doi: 10.1038/sj.mp.4001823. Epub 2006 Apr 4. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 2, 2026 | Jun 26, 2026 | 11 | ||
| Jun 30, 2026 |
| ID | Term |
|---|---|
| D009771 | Obsessive-Compulsive Disorder |
| D014256 | Trichotillomania |
| D005879 | Tourette Syndrome |
| D000067836 | Hoarding Disorder |
| D060845 | Hoarding |
| D000096705 | Excoriation Disorder |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D007174 | Disruptive, Impulse Control, and Conduct Disorders |
| D001480 | Basal Ganglia Diseases |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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Open-Label treatment study
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| Baseline to Week 2 |
| Hamilton Depression Rating Scale (HAM-D) | 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. | Baseline to Week 2 |
| Hamilton Anxiety Rating Scale (HAM-A) | 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. | Baseline to Week 2 |
| Sheehan Disability Scale (SDS) | 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. | Baseline to Week 2 |
| Quality of Life Inventory (QOLI) | 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. | Baseline to Week 2 |
| Background | Frisch MB, Cornell J, Villaneuva M (1993). Clinical validation of the Quality of Life Inventory: a measure of life satisfaction for use in treatment planning and outcome assessment. Psychol Assess. 4:92-101. |
| 25119610 | Background | Grant JE. Clinical practice: Obsessive-compulsive disorder. N Engl J Med. 2014 Aug 14;371(7):646-53. doi: 10.1056/NEJMcp1402176. |
| 14399272 | Background | HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available. |
| 13638508 | Background | HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available. |
| 7635854 | Background | Ravizza L, Barzega G, Bellino S, Bogetto F, Maina G. Predictors of drug treatment response in obsessive-compulsive disorder. J Clin Psychiatry. 1995 Aug;56(8):368-73. |
| Background | Sheehan DV (1983). The Anxiety Disease. New York: Scribner's. |
| 9881538 | Background | Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57. |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013981 | Tic Disorders |
| D009069 | Movement Disorders |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D065886 | Neurodevelopmental Disorders |
| D001519 | Behavior |
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |