This trial is active, not recruiting.

Conditions trichotillomania, hair pulling
Treatments n-acetylcysteine, placebo
Phase phase 2
Sponsor Yale University
Collaborator Trichotillomania Learning Center
Start date October 2009
End date April 2012
Trial size 34 participants
Trial identifier NCT00993265, 0906005337, NACPEDTTM


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
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.
2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks
(Placebo Comparator)
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.
placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks

Primary Outcomes

Massachusetts General Hospital Hair pulling Scale
time frame: 0,1,2,3,4,6,8,10,12 weeks

Secondary Outcomes

Trichotillomania Scale for Children - Child and Parent versions
time frame: 0,1,2,3,4,6,8,10,12 weeks
Multidimensional Anxiety Scale for Children (MASC)
time frame: 0,1,2,3,4,6,8,10,12 weeks
Children's Depression Inventory
time frame: 0,1,2,3,4,6,8,10,12 weeks
Yale Global Tic Severity Scale
time frame: 0,1,2,3,4,6,8,10,12 weeks
Children Yale-Brown Obsessive Compulsive Scale
time frame: 0,1,2,3,4,6,8,10,12 weeks
Clinical Global Improvement
time frame: 0,1,2,3,4,6,8,10,12 weeks

Eligibility Criteria

Male or female participants from 8 years up to 17 years old.

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

Additional Information

Official title Double-Blind, Placebo-Controlled Trial of N-acetylcysteine for the Treatment of Pediatric Trichotillomania
Principal investigator Michael H. Bloch, M.D., M.S.
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Yale University.