N-Acetyl Cysteine in Trichotillomania

This study has been completed.

First Received: July 18, 2006 Last Updated: October 16, 2008 History of Changes

Sponsor:	University of Minnesota - Clinical and Translational Science Institute
Information provided by:	University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:	NCT00354770

Purpose

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

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

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Trichotillomania

Resource links provided by NLM:

Drug Information available for: Cysteine Acetylcysteine Cysteine hydrochloride

U.S. FDA Resources

Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:

Massachusetts General Hospital Hairpulling Scale [ Time Frame: Beginning to end of study ] [ Designated as safety issue: No ]

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
1: Active Comparator N-Acetyl Cysteine	Drug: N-Acetyl Cysteine daily
2: Placebo Comparator 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

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 Minnesota - Clinical and Translational Science Institute

Investigators

Principal Investigator:

Jon E Grant, MD, JD

University of Minnesota - Clinical and Translational Science Institute

More Information

No publications provided by University of Minnesota - Clinical and Translational Science Institute

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Responsible Party:	University of Minnesota ( Jon E. Grant )
Study ID Numbers:	0604M85110
Study First Received:	July 18, 2006
Last Updated:	October 16, 2008
ClinicalTrials.gov Identifier:	NCT00354770 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:

Trichotillomania
Hair-pulling

Additional relevant MeSH terms:

Anti-Infective Agents
Respiratory System Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Trichotillomania
Protective Agents
Antiviral Agents
Pharmacologic Actions

Impulse Control Disorders
Mental Disorders
Expectorants
Therapeutic Uses
Free Radical Scavengers
Acetylcysteine
N-monoacetylcystine
Antidotes

ClinicalTrials.gov processed this record on February 08, 2010