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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00354770
Other study ID # 0604M85110
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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