Trial record 2 of 25 for:    "Trichotillomania"

N-Acetylcysteine for Pediatric Trichotillomania

This study has been completed.
Sponsor:
Collaborator:
Trichotillomania Learning Center
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00993265
First received: October 9, 2009
Last updated: June 26, 2014
Last verified: June 2014
  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 (MGH-HPS) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) is a 7-question scale that measures the severity of hair pulling. The scale ranges from 0-28. The higher the score, the more severe the hairpulling.


Secondary Outcome Measures:
  • Trichotillomania Scale for Children - Child Version [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The Trichotillomania Scale for Children (TSC) - Child Version assesses hair pulling severity, distress, and impairment in children. The scale is split into two sections (severity and distress/impairment), with 12 questions (5 severity and 7 distress/impairment). The severity score is summed from questions 1-5 and divided by 5. The distress/impairment score is summed from questions 6-12 and divided by 7. The total score is calculated by summing the severity score and the distress/impairment score. Scores range from 0-4. Higher total scores indicate greater severity/distress/impairment.

  • Multidimensional Anxiety Scale for Children (MASC) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The Multidimensional Anxiety Scale for Children (MASC) assesses major dimensions of anxiety in children. The MASC contains 39 items rated on a scale of 0-3. Scores range from 0-117. The higher the score, the greater the anxiety.

  • Children's Depression Inventory [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The Massachusetts General Hospital - Hairpulling Scale (MGH-HPS) is a 7-question scale that measures the severity of hair pulling. The scale ranges from 0-28. The higher the score, the more severe the hairpulling.

  • Trichotillomania Scale for Children - Parent Version [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The Trichotillomania Scale for Children (TSC) - Parent Version assesses hair pulling severity, distress, and impairment in children. The scale is split into two sections (severity and distress/impairment), with 12 questions (5 severity and 7 distress/impairment). The severity score is summed from questions 1-5 and divided by 5. The distress/impairment score is summed from questions 6-12 and divided by 7. The total score is calculated by summing the severity score and the distress/impairment score. Scores range from 0-4. Higher total scores indicate greater severity/distress/impairment.

  • The Milwaukee Inventory for Styles of Trichotillomania-Child Version [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The Milwaukee Inventory for Styles of Trichotillomania (MIST) - Child Version assesses "focused" pulling, hair pulling that occurs intentionally to relieve tension or distress, and "automatic" pulling, hair pulling that occurs outside of the child's attention. This scale contains 25 questions, 21 questions in the "focused" pulling subscale and 4 questions in the "automatic" pulling subscale. The scores range from 0-36 on the "automatic" pulling subscale and 0-189 on the "focused" pulling subscale. Higher scores on the subscales indicate more of the hair pulling is of that style.

  • National Institute of Mental Health -Trichotillomania Severity Scale (NIMH-TSS) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    The National Institute of Mental Health - Trichotillomania Severity Scale (NIMH-TSS) assesses severity of hair pulling. The NIMH-TSS is a 6 item assessment, with total scores ranging from 0-20. Higher scores indicate greater severity/impairment.


Enrollment: 39
Study Start Date: October 2009
Study Completion Date: March 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: Yale University
ClinicalTrials.gov Identifier: NCT00993265     History of Changes
Other Study ID Numbers: 0906005337, NACPEDTTM
Study First Received: October 9, 2009
Results First Received: March 7, 2014
Last Updated: June 26, 2014
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 August 28, 2014