CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 39 enrolled
Drug / intervention
N-Acetylcysteine +1 moredrug
Likely dose
N-Acetylcysteine 2400 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00993265
NCT00993265Phase 2Completed

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

Yale University·interventional·Posted Oct 12, 2009·Updated Jul 25, 2014

In Brief

A Phase 2 clinical trial evaluating N-Acetylcysteine and Placebo for Trichotillomania and Hair Pulling. Completed, enrolled 39 participants across 1 site.

Detailed 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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 12, 2009
Enrollment StartOct 1, 2009
Primary CompletionApr 1, 2012
Study CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 16.7 years ago

Interventions

N-Acetylcysteinedrug

2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks

Placebodrug

placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks