N-Acetyl Cysteine in Trichotillomania

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jon Grant, University of Chicago
ClinicalTrials.gov Identifier:
NCT00354770
First received: July 18, 2006
Last updated: December 12, 2013
Last verified: December 2013

July 18, 2006
December 12, 2013
July 2006
September 2008   (final data collection date for primary outcome measure)
Massachusetts General Hospital Hairpulling Scale [ Time Frame: Beginning to end of study every 2 weeks. ] [ Designated as safety issue: No ]
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 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
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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
Grant JE, Odlaug BL, Kim SW. N-acetylcysteine, a glutamate modulator, in the treatment of trichotillomania: a double-blind, placebo-controlled study. Arch Gen Psychiatry. 2009 Jul;66(7):756-63.

*   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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00354770
0604M85110
Yes
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
December 2013

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