Phase 2
N=39
N-Acetylcysteine for Pediatric Trichotillomania
Trichotillomania · Hair Pulling
Bottom Line
View on ClinicalTrials.gov: NCT00993265 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
Jul 2014
Primary outcome: Primary: Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) — 10.70; 13.53 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- N-Acetylcysteine (Drug); Placebo (Drug)
- Age
- Pediatric · 8+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Apr 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Massachusetts General Hospital Hair Pulling Scale (MGH-HPS) |
10.70; 13.53 | — |
| SECONDARY Trichotillomania Scale for Children - Child Version |
2.00; 2.08 | — |
| SECONDARY Multidimensional Anxiety Scale for Children (MASC) |
48.4; 49.8 | — |
| SECONDARY Children's Depression Inventory |
10.9; 7.8 | — |
| SECONDARY Trichotillomania Scale for Children - Parent Version |
1.83; 1.88 | — |
| SECONDARY The Milwaukee Inventory for Styles of Trichotillomania-Child Version |
13.24; 13.16; 90.8; 79.6 | — |
| SECONDARY National Institute of Mental Health -Trichotillomania Severity Scale (NIMH-TSS) |
9.56; 10.89 | — |
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
Data sourced from ClinicalTrials.gov (NCT00993265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.