N-Acetylcysteine for Pediatric Trichotillomania

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Brief Title

N-Acetylcysteine for Pediatric Trichotillomania

Official Title

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

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.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Massachusetts General Hospital Hair Pulling Scale (MGH-HPS)

Secondary Outcome

 Trichotillomania Scale for Children - Child Version

Condition

Trichotillomania

Intervention

N-Acetylcysteine

Study Arms / Comparison Groups

 N-acetylcysteine (NAC)
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

39

Start Date

October 2009

Completion Date

March 2014

Primary Completion Date

April 2012

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
      

Gender

All

Ages

8 Years - 17 Years

Accepts Healthy Volunteers

No

Contacts

Michael H. Bloch, M.D., M.S., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00993265

Organization ID

0906005337

Secondary IDs

NACPEDTTM

Responsible Party

Sponsor

Study Sponsor

Yale University

Collaborators

 Trichotillomania Learning Center

Study Sponsor

Michael H. Bloch, M.D., M.S., Principal Investigator, Yale University


Verification Date

June 2014