Epidiolex in Obsessive Compulsive Disorder and Related Disorders

NCT04978428 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: IRB21-1147
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Tourette Syndrome; Hoarding Disorder; Obsessive-Compulsive Disorder; Trichotillomania (Hair-Pulling Disorder)

Keywords

Obsessive Compulsive Disorder; CBD; Hoarding; Tourettes; Trichotillomania; Skin Picking Disorder; Body focused repetitive behaviors

Outcome Measures

Primary Outcomes (2)

• Change in Yale Brown Obsessive Compulsive Scale (YBOCS) Total Score

  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.

  Baseline to Week 2

• Change in NIMH Symptom Severity Scale (for TTM or Skin Picking) Total Score

  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.

  Baseline to Week 2

Secondary Outcomes (5)

• 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

Study Arms (1)

Epidiolex

EXPERIMENTAL

Epidiolex (2.5 mg/kg twice daily for one week) followed by Epidiolex (5mg/kg twice daily for two weeks)

Drug: Cannabidiol

Interventions

Cannabidiol DRUG

Epidiolex oral solution (2.5 mg/kg and 5 mg/kg)

Also known as: Epidiolex

Epidiolex

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (9)

• 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.

  PMID: 16848654 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.

  PMID: 16585942 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.

  BACKGROUND

• Grant JE. Clinical practice: Obsessive-compulsive disorder. N Engl J Med. 2014 Aug 14;371(7):646-53. doi: 10.1056/NEJMcp1402176.

  PMID: 25119610 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.

  PMID: 14399272 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.

  PMID: 13638508 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.

  PMID: 7635854 BACKGROUND

• Sheehan DV (1983). The Anxiety Disease. New York: Scribner's.

  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.

  PMID: 9881538 BACKGROUND

MeSH Terms

Conditions

Obsessive-Compulsive Disorder; Trichotillomania; Tourette Syndrome; Hoarding Disorder; Hoarding; Excoriation Disorder

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Disruptive, Impulse Control, and Conduct Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tic Disorders; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Behavior; Self-Injurious Behavior; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Dr. Jon E. Grant
• Organization: University of Chicago

jgrant4@bsd.uchicago.edu

773-834-1325

Study Officials

• Jon E Grant, MD, JD, MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-Label treatment study

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: July 27, 2021
• Study Start: April 14, 2022
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: July 29, 2026
• Results First Posted: July 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)