Cannabidiol
Epidiolex oral solution (2.5 mg/kg and 5 mg/kg)
EpidiolexLoading study record…
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-07-29
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
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).
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Epidiolex oral solution (2.5 mg/kg and 5 mg/kg)
EpidiolexSource-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Epidiolex | 2 | 2 | 4.24 |
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.
Population: Only participants who demonstrated hair pulling or skin picking were given this measure. Only one participant completed the entire study, and this participant did not express these symptoms. While there was one participant who did demonstrate these behaviors and did complete this measure in the first two visits, they did not complete the third visit.
Eligibility
primary outcomes
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. 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.
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 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 outcomes
Time frame: 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"
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Week 2
Publications
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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"
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Epidiolex | 2 | 0 | 1.41 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Epidiolex | 2 | 1.5 | 7.78 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Epidiolex | 2 | 0.5 | 0.71 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Epidiolex | 2 | 0 | 9.90 |
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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Epidiolex | 2 | -3.5 | 4.95 |
| Milestone | Epidiolex |
|---|---|
| STARTED | 4 |
| COMPLETED | 2 |
| NOT COMPLETED | 2 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Diarrhea | Gastrointestinal disorders | Epidiolex: 1 / 4 |
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.