Epidiolex in Obsessive Compulsive Disorder and Related Disorders

NCT04978428 | Completed Phase 2 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 (4)

• 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.

  Baseline to Week 2

Secondary Outcomes (5)

• Clinical Global Impressions- Improvement Scale (CGI-I)

  Baseline to Week 2

• Hamilton Depression Rating Scale (HAM-D)

  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

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

Study Officials

• Jon E Grant, MD, JD, MPH

  University of Chicago

  PRINCIPAL INVESTIGATOR

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: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)