N-Acetylcysteine for Pediatric Trichotillomania

Condition(s) targeted: Trichotillomania; Hair Pulling

Intervention: N-Acetylcysteine (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Yale University

Official(s) and/or principal investigator(s):
Michael H. Bloch, M.D., M.S., Principal Investigator, Affiliation: Yale University

Overall contact:
Kaitlyn E. Panza, B.A., Phone: (203) 737-4809, Email: michael.bloch@yale.edu

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.

Official title: Double-Blind, Placebo-Controlled Trial of N-acetylcysteine for the Treatment of Pediatric Trichotillomania

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Massachusetts General Hospital Hair pulling Scale

Secondary outcome:

Trichotillomania Scale for Children - Child and Parent versions

Multidimensional Anxiety Scale for Children (MASC)

Children's Depression Inventory

Yale Global Tic Severity Scale

Children Yale-Brown Obsessive Compulsive Scale

Clinical Global Improvement

Minimum age: 8 Years. Maximum age: 17 Years. Gender(s): Both.

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

Kaitlyn E. Panza, B.A., Phone: (203) 737-4809, Email: michael.bloch@yale.edu

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

Related 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.

Starting date: October 2009
Ending date: October 2011
Last updated: October 9, 2009