- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01063348
N-Acetyl Cysteine in Pathologic Skin Picking
A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Pathologic Skin Picking
Study Overview
Status
Intervention / Treatment
Detailed Description
Pathologic skin picking involves repetitive, ritualistic, or impulsive picking of otherwise normal skin leading to tissue damage, personal distress, and impaired functioning. Although skin picking has been described in the medical literature for over one-hundred years, it remains a poorly understood psychiatric issue and often goes undiagnosed and untreated.
Picking behavior does not by itself suggest a psychiatric disorder. Pathology exists in the focus, duration and extent of the behavior, as well as the reasons for picking, associated emotions, and resulting problems. Patients with PSP report thoughts of picking or impulses to pick that are irresistible, intrusive and/or senseless. These thoughts, impulses, or behaviors also cause marked distress for patients and significantly interfere with other activities. Unlike normal picking behavior, the pathologic form of skin picking is recurrent and usually results in noticeable skin damage.
Thirty subjects with pathologic skin picking will receive 12 weeks of double-blind treatment with N-acetyl cysteine or matching placebo. The hypothesis to be tested is that N-acetyl cysteine will be more effective than placebo in patients with pathologic skin picking. The proposed study will provide needed data on the treatment of an often disabling disorder that currently lacks a clearly effective treatment.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Men and women age 18-65;
- Current diagnosis of pathologic skin picking as determined by criteria proposed by Arnold et al. (2001) for at least 6 months duration
Exclusion Criteria:
- Unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination;
- History of seizures;
- Myocardial infarction within 6 months;
- Current pregnancy or lactation, or inadequate contraception in women of childbearing potential;
- Need for medication other than NAC with possible psychotropic effects or unfavorable interactions with NAC;
- Clinically significant suicidality (score or 3 or 4 on item 3 of the Hamilton Depression Rating Scale);
- Lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder;
- Current or recent (past 3 months) DSM-IV substance abuse or dependence;
- Illegal substance use within 2 weeks of study initiation;
- Initiation of pharmacotherapy, psychotherapy, or behavior therapy from a mental health professional within 3 months prior to study baseline for the treatment of pathologic skin picking;
- Previous treatment with N-acetyl cysteine;
- Treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks prior to study baseline;
- Asthma (given possible worsening of asthma due to NAC)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: N-Acetyl Cysteine
N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)
|
Week 0 (Visit 1) - Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) - Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) - Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)
Other Names:
|
Placebo Comparator: Placebo
Matching placebo taken daily
|
Matching placebo capsules taken in same amount of pills as the active medication.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS)
Time Frame: Once every three weeks during the 12 week study for each subject
|
The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed. The minimum score is 0 and the maximum score is 40, with a higher score being more severe skin picking. There are two sub-scales: one for urges (ranges from 0 to 20) and one for behaviors (ranges from 0 to 20). The total of the scores of each of the sub-scales is the total YBOCS score. That is what will be reported. |
Once every three weeks during the 12 week study for each subject
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin Picking Self Assessment Scale (SP-SAS)
Time Frame: Once every three weeks for the duration of the 12 week study for each subject
|
The entire study for an individual subject will last 12 weeks. Every 3 weeks the subject will take the YBOCS for the duration of the 12 weeks. At each of these visits the outcome will be assessed. The minimum score is 0 and the maximum score is 48 with higher scores meaning more severe skin picking. The total of all of the questions equals the total reported SP-SAS score. |
Once every three weeks for the duration of the 12 week study for each subject
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jon E Grant, MD, JD, MPH, University of Chicago
Publications and helpful links
General Publications
- Arnold LM, Auchenbach MB, McElroy SL. Psychogenic excoriation. Clinical features, proposed diagnostic criteria, epidemiology and approaches to treatment. CNS Drugs. 2001;15(5):351-9. doi: 10.2165/00023210-200115050-00002.
- Grant JE, Odlaug BL. Update on pathological skin picking. Curr Psychiatry Rep. 2009 Aug;11(4):283-8. doi: 10.1007/s11920-009-0041-x.
- Grant JE, Chamberlain SR, Redden SA, Leppink EW, Odlaug BL, Kim SW. N-Acetylcysteine in the Treatment of Excoriation Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2016 May 1;73(5):490-6. doi: 10.1001/jamapsychiatry.2016.0060.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010PSPNAC
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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