NCT00453180

A Study of Oral N-Acetylcysteine in Children With Autism Spectrum Disorders

A Pilot Study of Oral N-Acetylcysteine in Children With Autism Spectrum Disorders

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Indiana University School of Medicine · Academic / Other
• Sex: All
• Age: 4 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether treatment with oral N-acetylcysteine (NAC) will improve behavior problems often associated with autism spectrum disorders.

Detailed description

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.

Conditions

• Autistic Disorder
• Asperger Syndrome
• Child Development Disorders, Pervasive

Interventions

Type	Name	Description
DRUG	N-acetylcysteine	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.
DRUG	Placebo	Subjects randomized to placebo arm will receive placebo pill for duration of study.

Timeline

• Start date: 2007-03-01
• Primary completion: 2009-08-01
• Completion: 2009-11-01
• First posted: 2007-03-28
• Last updated: 2017-06-14
• Results posted: 2017-06-14

Locations

1 site across 1 country: United States