Clinical trial NCT00993265: N-Acetylcysteine for Pediatric Trichotillomania
Official title: Double-Blind, Placebo-Controlled Trial of N-acetylcysteine for the Treatment of Pediatric Trichotillomania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Trichotillomania
Hair Pulling
Keywords: Trichotillomania
Hair pulling
glutamate
N-Acetylcysteine
Children
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Trichotillomania Learning Center
First posted: 2009-10-12
Enrollment: 39
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)
timeFrame: Week 12
Secondary outcomes:
measure: Trichotillomania Scale for Children - Child Version
timeFrame: Week 12
measure: Multidimensional Anxiety Scale for Children (MASC)
timeFrame: Week 12
measure: Children's Depression Inventory
timeFrame: Week 12
measure: Trichotillomania Scale for Children - Parent Version
timeFrame: Week 12
measure: The Milwaukee Inventory for Styles of Trichotillomania-Child Version
timeFrame: Week 12
measure: National Institute of Mental Health -Trichotillomania Severity Scale (NIMH-TSS)
timeFrame: Week 12
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Child Study Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Michael H. Bloch, M.D., M.S.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bloch MH. Trichotillomania across the life span. J Am Acad Child Adolesc Psychiatry. 2009 Sep;48(9):879-883. doi: 10.1097/CHI.0b013e3181ae09f3. No abstract available.
citation: 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. doi: 10.1001/archgenpsychiatry.2009.60.
citation: Hoffman J, Williams T, Rothbart R, Ipser JC, Fineberg N, Chamberlain SR, Stein DJ. Pharmacotherapy for trichotillomania. Cochrane Database Syst Rev. 2021 Sep 28;9(9):CD007662. doi: 10.1002/14651858.CD007662.pub3.
citation: Schumer MC, Panza KE, Mulqueen JM, Jakubovski E, Bloch MH. LONG-TERM OUTCOME IN PEDIATRIC TRICHOTILLOMANIA. Depress Anxiety. 2015 Oct;32(10):737-43. doi: 10.1002/da.22390. Epub 2015 Jul 2.
citation: 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.
citation: 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.