Epidiolex in Obsessive Compulsive Disorder and Related Disorders

March 8, 2024 updated by: University of Chicago

An Open-Label Trial of Epidiolex in the Treatment of Obsessive Compulsive Disorder and Related Disorders: Proof of Concept Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Principal Investigator:
          • Jon E Grant, MD, JD, MPH
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Epidiolex
Epidiolex (2.5 mg/kg twice daily for one week) followed by Epidiolex (5mg/kg twice daily for two weeks)
Drug: Cannabidiol
Epidiolex oral solution (2.5 mg/kg and 5 mg/kg)
Other Names:
  • Epidiolex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 2
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.
Baseline to Week 2
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.
Baseline to Week 2
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.
Baseline to Week 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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"
Baseline to Week 2
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.
Baseline to Week 2
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.
Baseline to Week 2
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.
Baseline to Week 2
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.
Baseline to Week 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Investigators

  • Principal Investigator: Jon E Grant, MD, JD, MPH, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2022

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

July 20, 2021

First Submitted That Met QC Criteria

July 20, 2021

First Posted (Actual)

July 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 8, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB21-1147

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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