N-Acetylcysteine for Pediatric Trichotillomania

• 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 ]

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.

• 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

• 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.
• Panza KE, Pittenger C, Bloch MH. Age and gender correlates of pulling in pediatric trichotillomania. J Am Acad Child Adolesc Psychiatry. 2013 Mar;52(3):241-9. doi: 10.1016/j.jaac.2012.12.019.
• Bloch MH, Panza KE, Grant JE, Pittenger C, Leckman JF. N-acetylcysteine in the treatment of pediatric trichotillomania: a randomized, double-blind, placebo-controlled add-on trial. J Am Acad Child Adolesc Psychiatry. 2013 Mar;52(3):231-40. doi: 10.1016/j.jaac.2012.12.020.

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