N-Acetyl Cysteine in Trichotillomania

Study Overview
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Brief Summary
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This is a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of trichotillomania

Detailed Description
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The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine (NAC) in trichotillomania. Forty subjects with DSM-IV trichotillomania will receive 12 weeks of double-blind NAC or placebo. The hypothesis to be tested is that NAC will be effective and well tolerated in patients with trichotillomania compared to placebo. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Official Title
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A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Trichotillomania

Conditions
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Trichotillomania

Intervention / Treatment
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* Drug: Placebo
* Drug: N-Acetyl Cysteine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women age 18-65; current DSM-IV trichotillomania Exclusion Criteria: unstable medical illness; history of seizures; myocardial infarction within 6 months; current pregnancy or lactation, or inadequate contraception in women of childbearing potential; any thoughts of suicide; lifetime history of DSM-IV bipolar disorder type I, dementia, or schizophrenia or any other DSM-IV psychotic disorder; 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; 9) diagnosis of asthma

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: N-Acetyl Cysteine<br>N-Acetyl Cysteine | Drug: N-Acetyl Cysteine<br>* 600mg capsules in varying doses for 12 weeks.<br>* Other names: NAC;|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo<br>* daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Massachusetts General Hospital Hairpulling Scale | There is no minimum or maximum score to quantify 'good' or 'poor' improvement based on this scale. The total score can range from 0-28 with zero being no problems to 28 being the most severe score one can receive.A total of 6 assessments were made, however only the final score (the score at the final visit after 12 weeks) was reported here to show the final outcome measure that was used in the final report of possible improvement and what was reported for final publication of data. | Baseline and final visit after 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trichotillomania, Hair-pulling