Phase 2
N=66
N-Acetyl Cysteine in Pathologic Skin Picking
Pathologic Skin Picking · Neurotic Excoriation · Psychogenic Excoriation · Dermatillomania
Bottom Line
View on ClinicalTrials.gov: NCT01063348 ↗Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Oct 2016
Primary outcome: Primary: Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS) — 18.8; 17.6; 16.1; 17.3 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N-Acetyl Cysteine (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Jul 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Yale Brown Obsessive Compulsive Scale (YBOCS) Modified for PSP (NE-YBOCS) |
18.8; 17.6; 16.1; 17.3; 13.9; 16.3 | — |
| SECONDARY Skin Picking Self Assessment Scale (SP-SAS) |
28.6; 28.6; 24.8; 25.5; 21.9; 25.0 | — |
Summary
The goal of the proposed study is to evaluate the comparative efficacy of N-acetyl cysteine to placebo in pathologic skin picking. 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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT01063348). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.