N-Acetylcysteine for Pediatric Trichotillomania - Full Text View

Sponsor:	Yale University
Collaborator:	Trichotillomania Learning Center
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00993265

Purpose

Trichotillomania (hair pulling) has an estimated lifetime prevalence of 1-3%. Children with trichotillomania can experience significant impairment due to peer teasing, avoidance of activities (such as swimming and socializing), difficulty concentrating on school work and medical complications due to pulling behaviors. Despite the fact that trichotillomania has a childhood onset, no randomized, controlled trials have been completed in childhood trichotillomania.

Research in adults with trichotillomania has demonstrated that most commonly currently prescribed treatment for trichotillomania, (pharmacotherapy with selective serotonin reuptake inhibitors) is ineffective in treating this condition. By contrast, randomized controlled trials in adults have suggested the efficacy of N-acetylcysteine as well as behavioral treatments such as Habit Reversal Therapy.

The goal of this trial is to determine the efficacy of N-Acetylcysteine for pediatric trichotillomania. N-Acetylcysteine is a glutamate modulating agent, with a fairly benign side-effect profile.

Condition	Intervention	Phase
Trichotillomania Hair Pulling	Drug: N-Acetylcysteine Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Double-Blind, Placebo-Controlled Trial of N-acetylcysteine for the Treatment of Pediatric Trichotillomania

Resource links provided by NLM:

Drug Information available for: Acetylcysteine

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

Massachusetts General Hospital Hair pulling Scale [ Time Frame: 0,1,2,3,4,6,8,10,12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Trichotillomania Scale for Children - Child and Parent versions [ Time Frame: 0,1,2,3,4,6,8,10,12 weeks ] [ Designated as safety issue: No ]
Multidimensional Anxiety Scale for Children (MASC) [ Time Frame: 0,1,2,3,4,6,8,10,12 weeks ] [ Designated as safety issue: No ]
Children's Depression Inventory [ Time Frame: 0,1,2,3,4,6,8,10,12 weeks ] [ Designated as safety issue: No ]
Yale Global Tic Severity Scale [ Time Frame: 0,1,2,3,4,6,8,10,12 weeks ] [ Designated as safety issue: No ]
Children Yale-Brown Obsessive Compulsive Scale [ Time Frame: 0,1,2,3,4,6,8,10,12 weeks ] [ Designated as safety issue: No ]
Clinical Global Improvement [ Time Frame: 0,1,2,3,4,6,8,10,12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	34
Study Start Date:	October 2009
Estimated Study Completion Date:	October 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: N-acetylcysteine (NAC) Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.	Drug: N-Acetylcysteine 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks
Placebo Comparator: Placebo Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.	Drug: Placebo placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks

Eligibility

Ages Eligible for Study:	8 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Children aged 8-17 years.
Primary DSM-IV diagnosis of trichotillomania or chronic hair pulling.
Duration of trichotillomania greater than 6 months.

Exclusion Criteria:

Comorbid bipolar disorder, psychotic disorder, substance use disorder, developmental disorder or mental retardation (IQ<70).
Recent change (less than 4 weeks) in medications that have potential effects on TTM severity (such as SSRIs, CMI, naltrexone, lithium, psychostimulants, anxiolytics, or antipsychotics). Medication change is defined to include either dose changes or medication discontinuation.
Asthma requiring medication use within the last 6 months.
Known hypersensitivity or previous anaphylactoid reaction to acetylcysteine or any components in its preparation
Current use (within last week) of psychostimulant medications.
Positive pregnancy test or drug screening test

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993265

Contacts

Contact: Kaitlyn E. Panza, B.A.	(203) 737-4809	kaitlyn.panza@yale.edu
Contact: Michael H. Bloch, M.D., M.S.	203-974-7551	michael.bloch@yale.edu

Locations

United States, Connecticut
Yale Child Study Center	Recruiting
New Haven, Connecticut, United States, 06520

Sponsors and Collaborators

Yale University

Trichotillomania Learning Center

Investigators

Principal Investigator:

Michael H. Bloch, M.D., M.S.

Yale University

More Information

Publications:

Bloch MH. Trichotillomania across the life span. J Am Acad Child Adolesc Psychiatry. 2009 Sep;48(9):879-83. No abstract available.

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:	Michael H. Bloch M.D., M.S., Yale Child Study Center
ClinicalTrials.gov Identifier:	NCT00993265 History of Changes
Other Study ID Numbers:	0906005337, NACPEDTTM
Study First Received:	October 9, 2009
Last Updated:	July 27, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

Trichotillomania
Hair pulling
glutamate
N-Acetylcysteine
Children

Additional relevant MeSH terms:

Trichotillomania
Impulse Control Disorders
Mental Disorders
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on February 09, 2012