Double-blind , Randomized, Placebo Controlled Study of N-Acetyl Cysteine in Autism.

The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC) in children with Autism. NAC is a compound that increases the levels of Glutathione, the body's main antioxidant. Glutathione is a compound in the blood that is part of a natural defense system (the antioxidant system). Anti-oxidants protect the body from damage caused by internal toxins called "free radicals." It is possible that children with Autism tend to have lower levels of glutathione, an important compound in our bodies that helps combat the effects of toxic free radicals. We hope that by studying the antioxidant system in more detail, we will increase our understanding of the reasons why people develop Autism so that we can design better ways to treat individuals with this condition. This study is meant to test the safety tolerability of NAC and its effectiveness in the treatment of behavioral difficulties in children with autism. It will also examine the possible benefit of this agent in improving the core deficits in autism such as social deficits.

Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.

Investigator(s):

Intervention(s):

  • drug : N-Acetyl Cysteine
  • other : Placebo - sugar pill

Phase: Phase 2

Eligibility

Ages Eligible For Study:

3 Years - 12 Years

Inclusion Criteria

1. Outpatients between 3.0 and 12.11 years of age inclusive 2. Males and females who are physically healthy 3. diagnosis of autism based DSM-IV- TR criteria, the Autism Diagnostic Interview-Revised, and expert clinical evaluation 4. CGI Severity rating of 4 5. Care provider who can reliably bring subject to clinic visits, can provide trustworthy ratings, and interacts with subject on a regular basis 6. Ability of subject to swallow the compound 7. Stable concomitant medications for at least 2 weeks 8. No planned changes in psychosocial interventions during the open-label NAC trial

External Links

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Contact information

Primary Contact:

Robin Libove 6507361235

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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