Hoarding Disorder, Obsessive-Compulsive Disorder, Tourette Syndrome, Trichotillomania (Hair-Pulling Disorder)
Conditions
Keywords
Obsessive Compulsive Disorder, CBD, Hoarding, Tourettes, Trichotillomania, Skin Picking Disorder, Body focused repetitive behaviors
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).
Interventions
DRUGCannabidiol
Epidiolex oral solution (2.5 mg/kg and 5 mg/kg)
Sponsors
University of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open-Label treatment study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Yale Brown Obsessive Compulsive Scale (YBOCS) Total Score | 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. 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. |
| Change in NIMH Symptom Severity Scale (for TTM or Skin Picking) Total Score | 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Global Impressions- Severity Scale (CGI-S) Total Score | Baseline to Week 2 | The entire study for the subject will last 2 weeks. The subject will complete the CGI once per week. The change in scores from baseline to Week 2 will be reported. 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" |
| Change in Hamilton Depression Rating Scale (HAM-D) Total Score | Baseline to Week 2 | The Hamilton Depression Rating Scale (HAM-D) is a clinician-administered assessment of depression that will be assessed at all study visits. The HAM-D is a 17-item scale that assess depressive symptoms during the last seven days. The change in scores from baseline to Week 2 will be reported. The scale ranges from 0-52 with higher total scores indicating higher levels of depression, while a score of 0 would indicate no depressive symptoms. |
| Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score | Baseline to Week 2 | The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered assessment of anxiety that will be assessed at all study visits. The HAM-A is a 14 item scale that assess anxiety symptoms during the last fourteen days. The change in scores from baseline to Week 2 will be reported. The scale ranges from 0-56 with higher scores indicating higher levels of anxiety, with 0 being no symptoms of anxiety. |
| Change in Sheehan Disability Scale (SDS) Total Score | Baseline to Week 2 | The Sheehan Disability Scale (SDS) is a self-report scale that subjects will complete the SDS at all visits. The SDS is a three item scale that measures functional impairment across work/school, social life, and family/home responsibilities during the past seven days. The change in scores from baseline to Week 2 will be reported. Each item ranges from 0-10, with higher scores indicating more impairment. However, only total score is reported which ranges from 0-30, with higher scores indicating more severe impairment. The total score is computed by summing the three scores from each domain. The scale itself assesses the level of disability from target disorder with higher scores indicating a more debilitating disorder. |
| Change in Quality of Life Inventory (QOLI) Total Score | Baseline to Week 2 | The Quality of Life Inventory (QOLI) is a self-report assessment of patient perceived quality of life that will be assessed at each visit. The change in scores from baseline to Week 2 will be reported. The QOLI assesses both the importance and satisfaction of 16 life domains. Scores are calculated by multiplying the importance score by the satisfaction score which gives a weighted score for each domain. Each weighted score is then added together to get a total score which ranges from 0-100 with higher scores indicating a higher quality of life, whereas lower scores indicate a lower quality of life. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJon E Grant, MD, JD, MPH
University of Chicago
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 26 Years STANDARD_DEVIATION 6.63 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 3 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 4 |
| other Total, other adverse events | 1 / 4 |
| serious Total, serious adverse events | 0 / 4 |
Outcome results
None listed