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

October 9, 2009
June 26, 2014
October 2009
April 2012   (final data collection date for primary outcome measure)
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.
Massachusetts General Hospital Hair pulling Scale [ Time Frame: 0,1,2,3,4,6,8,10,12 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00993265 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 ]
Not Provided
Not Provided
 
N-Acetylcysteine for Pediatric Trichotillomania
Double-Blind, Placebo-Controlled Trial of N-acetylcysteine for the Treatment of Pediatric Trichotillomania

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Trichotillomania
  • Hair Pulling
  • Drug: N-Acetylcysteine
    2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks
  • Drug: Placebo
    placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks
  • 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.
    Intervention: Drug: N-Acetylcysteine
  • 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.
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
39
March 2014
April 2012   (final data collection date for primary outcome measure)

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
Both
8 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00993265
0906005337, NACPEDTTM
No
Yale University
Yale University
Trichotillomania Learning Center
Principal Investigator: Michael H. Bloch, M.D., M.S. Yale University
Yale University
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP