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A Study of N-Acetyl Cysteine in Children With Autism
Not Recruiting
Trial ID: NCT00627705,25503
Purpose
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.
Official Title
Double-blind , Randomized, Placebo Controlled Study of N-Acetyl Cysteine in Autism.
Stanford Investigator(s)
Antonio Hardan, M.D.
Professor of Psychiatry and Behavioral Sciences
Eligibility
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 Diagnostic and Statistical Manual (DSM-IV-TR) criteria, the
Autism Diagnostic Interview-Revised, and expert clinical evaluation
4. Clinical Global Impression 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 N-Acetyl
Cysteine trial
Exclusion Criteria:
1. DSM-IV-TR diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder
not otherwise specified
2. Prior adequate trial of N-Acetyl Cysteine
3. Active medical problems: unstable seizures, significant physical illness (e.g.,
serious liver or renal pathology)
4. Pregnancy or sexually active females
5. Subjects taking antioxidant agents and glutathione prodrugs will be excluded from the
study except if they have been off these compounds for at least 4 weeks
Intervention(s):
other: Placebo - sugar pill
drug: N-Acetyl Cysteine
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Robin Libove
6507361235