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N-Acetyl Cysteine in Trichotillomania

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00354770
First Posted: July 20, 2006
Last Update Posted: December 16, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jon Grant, University of Chicago
July 18, 2006
July 20, 2006
March 1, 2012
January 15, 2014
December 16, 2016
July 2006
September 2008   (Final data collection date for primary outcome measure)
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.
Massachusetts General Hospital Hairpulling Scale
Complete list of historical versions of study NCT00354770 on ClinicalTrials.gov Archive Site
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N-Acetyl Cysteine in Trichotillomania
A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Trichotillomania
This is a 12-week, double-blind study of N-Acetyl Cysteine in the treatment of trichotillomania
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Trichotillomania
  • Drug: Placebo
    daily
  • Drug: N-Acetyl Cysteine
    600mg capsules in varying doses for 12 weeks.
    Other Name: NAC
  • Active Comparator: N-Acetyl Cysteine
    N-Acetyl Cysteine
    Intervention: Drug: N-Acetyl Cysteine
  • Placebo Comparator: 2
    Placebo
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
September 2008
September 2008   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00354770
0604M85110
Yes
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Jon Grant, University of Chicago
University of Chicago
Not Provided
Principal Investigator: Jon E Grant, MD, JD University of Minnesota - Clinical and Translational Science Institute
University of Chicago
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP