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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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 Summary:

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.

Sponsor: Indiana University School of Medicine

Current Primary Outcome:

  • 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 ]


Original Primary Outcome:

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

Information By: Indiana University

Dates:
Date Received: March 27, 2007
Date Started: March 2007
Date Completion:
Last Updated: June 3, 2014
Last Verified: June 2014