Clinical trial NCT04978428: Epidiolex in Obsessive Compulsive Disorder and Related Disorders
Official title: An Open-Label Trial of Epidiolex in the Treatment of Obsessive Compulsive Disorder and Related Disorders: Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obsessive-Compulsive Disorder
Trichotillomania (Hair-Pulling Disorder)
Tourette Syndrome
Hoarding Disorder
Keywords: Obsessive Compulsive Disorder
CBD
Hoarding
Tourettes
Trichotillomania
Skin Picking Disorder
Body focused repetitive behaviors
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-Label treatment study
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Yale Brown Obsessive Compulsive Scale (YBOCS)
timeFrame: Baseline to Week 2
measure: NIMH Symptom Severity Scale (for TTM or Skin Picking)
timeFrame: Baseline to Week 2
measure: The Hoarding Rating Scale (HRS)
timeFrame: Baseline to Week 2
measure: Yale Global Tic Severity Scale (YGTSS)
timeFrame: Baseline to Week 2
Secondary outcomes:
measure: Clinical Global Impressions- Improvement Scale (CGI-I)
timeFrame: Baseline to Week 2
measure: Hamilton Depression Rating Scale (HAM-D)
timeFrame: Baseline to Week 2
measure: Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: Baseline to Week 2
measure: Sheehan Disability Scale (SDS)
timeFrame: Baseline to Week 2
measure: Quality of Life Inventory (QOLI)
timeFrame: Baseline to Week 2
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Jon E Grant, MD, JD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Grant JE. Clinical practice: Obsessive-compulsive disorder. N Engl J Med. 2014 Aug 14;371(7):646-53. doi: 10.1056/NEJMcp1402176.
citation: 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.
citation: 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.
citation: 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.
citation: Sheehan DV (1983). The Anxiety Disease. New York: Scribner's.
citation: 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.