N-Acetylcysteine for Pediatric Trichotillomania

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Trichotillomania Learning Center
Information provided by (Responsible Party):
Michael Bloch, Yale University
ClinicalTrials.gov Identifier:
NCT00993265
First received: October 9, 2009
Last updated: October 3, 2012
Last verified: October 2012
  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 2

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:


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 2014
Primary Completion Date: April 2012 (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
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: NCT00993265

Locations
United States, Connecticut
Yale Child Study Center
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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michael Bloch, Assistant Professor, Yale University
ClinicalTrials.gov Identifier: NCT00993265     History of Changes
Other Study ID Numbers: 0906005337, NACPEDTTM
Study First Received: October 9, 2009
Last Updated: October 3, 2012
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 July 22, 2014