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Completed

NCT Number: NCT00354770

N-Acetyl Cysteine in Trichotillomania

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

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Key information

Conditions

Trichotillomania Anxiety Disorders Disruptive, Impulse Control, and Conduct Disorders Mental Disorders Obsessive-Compulsive Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

daily

N-acetyl cysteine

Drug

600mg capsules in varying doses for 12 weeks.

Other names: NAC

Primary outcomes

  1. Massachusetts General Hospital Hairpulling Scale

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Jul 20, 2006
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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