Trial record 4 of 25 for:    "Trichotillomania"

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: July 7, 2014
Last verified: July 2014
  Purpose

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


Condition Intervention Phase
Trichotillomania
Drug: Placebo
Drug: N-Acetyl Cysteine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Trichotillomania

Resource links provided by NLM:


Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • 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.


Enrollment: 50
Study Start Date: July 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: N-Acetyl Cysteine
N-Acetyl Cysteine
Drug: N-Acetyl Cysteine
600mg capsules in varying doses for 12 weeks.
Other Name: NAC
Placebo Comparator: 2
Placebo
Drug: Placebo
daily

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00354770

Locations
United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55454
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Jon E Grant, MD, JD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided by University of Chicago

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jon Grant, Professor of Psychiatry, University of Chicago
ClinicalTrials.gov Identifier: NCT00354770     History of Changes
Other Study ID Numbers: 0604M85110
Study First Received: July 18, 2006
Results First Received: March 1, 2012
Last Updated: July 7, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Trichotillomania
Hair-pulling

Additional relevant MeSH terms:
Trichotillomania
Impulse Control Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Anti-Infective Agents
Antidotes
Antioxidants
Antiviral Agents
Expectorants
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014