A Study of Oral N-Acetylcysteine in Children With Autism Spectrum Disorders
Child Development Disorders, Pervasive
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||A Pilot Study of Oral N-Acetylcysteine in Children With Autism Spectrum Disorders|
- Clinical Global Impression - Severity done at Screen, Baseline, and at the end of week 12 of treatment [ Time Frame: performed at screen, baseline, and end of treatment at week 12 ]
- Clinical Global Impression - Improvement done at the end of weeks 4, 8, and 12 of treatment [ Time Frame: performed at end of weeks 4, 8, and 12 of treatment ]
- Aberrant Behavior Checklist done at Baseline and end of weeks 4, 8, and 12 [ Time Frame: Performed at end of weeks 4, 8, 12 ]
- Social Responsiveness Scale done at Baseline and end of weeks 4, 8, and 12 [ Time Frame: Performed at baseline and end of weeks 4, 8, and 12 of treatment ]
- Pervasive Developmental Disorder Behavior Index done at Baseline and end of week 12 [ Time Frame: Performed at Baseline and end of week 12 ]
- Vineland Adaptive Behavior Scales done at Baseline and end of week 12 [ Time Frame: Performed at Baseline and end of week 12 ]
|Study Start Date:||March 2007|
|Study Completion Date:||November 2009|
|Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.
Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day.
Placebo Comparator: 2
Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain in active ingredients.
Subjects randomized to placebo arm will receive placebo pill for duration of study.
Autism is increasingly being recognized as a common disorder with enormous public health significance. The core symptoms of autism include severe deficits in social relatedness and communication, and interfering repetitive behavior. No medications have been shown to consistently improve any of these symptoms.
The central hypothesis of this study is that NAC will improve behavioral manifestations of autism which may include core or associated symptoms. We plan to test our hypothesis and complete the objectives of this project by pursuing the following specific aims:
- Evaluate the efficacy of oral NAC in a 12-week, double-blind, placebo-controlled study involving 32 children and adolescents with autism spectrum disorders.
- Evaluate the safety and tolerability of oral NAC in 32 children and adolescents with autism spectrum disorders.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00453180
|United States, Indiana|
|Riley Hospital for Children - Christian Sarkine Autism Treatment Center|
|Indianapolis, Indiana, United States, 46202|
|Principal Investigator:||Kimberly A Stigler, M.D.||Indiana University School of Medicine|