N-Acetyl Cysteine in Trichotillomania

Trichotillomania Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00354770
• Other study ID #: 0604M85110
• Status: Completed
• Phase: Phase 2
• Start date: July 2006
• Est. completion date: September 2008

Study information

• Verified date: February 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Trichotillomania

Intervention

Drug:
• Placebo
daily
• N-Acetyl Cysteine
600mg capsules in varying doses for 12 weeks.

Locations

Country	Name	City	State
United States	University of Chicago Medical Center	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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