N-Acetyl Cysteine in Trichotillomania

Phase 2

Completed

• Conditions: Trichotillomania
• Interventions: Drug: N-Acetyl Cysteine; Drug: Placebo

• Registration Number: NCT00354770
• Lead Sponsor: University of Chicago

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-18
• Study First Submitted QC: 2006-07-18
• Study First Posted: 2006-07-20
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2012-03-01
• Results First Submitted QC: 2013-12-12
• Results First Posted: 2014-01-15
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
N-Acetyl Cysteine	N-Acetyl Cysteine	N-Acetyl Cysteine
2	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Massachusetts General Hospital Hairpulling Scale	Baseline and final visit after 12 weeks	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.

Trial Locations

Locations (1)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States