An Open-Label Study of N-Acetyl Cysteine in Children With Autism
Completed · Phase 2
Conditions studied: Autistic Disorder
In brief
The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC) in children with Autism.
Key facts
- Study ID
- NCT00676195
- Run by
- Stanford University
- People needed
- 24
- Starts
- 2008-06-01
- Expected to finish
- 2010-06-01
- Last updated by the study team
- 2017-03-29
Who can join
Age: 3 and older, up to 12. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects will be eligible for this study if they participated in the Double-blind, randomized, placebo controlled study of N-Acetyl Cysteine in Autism study at Stanford University and meet all of the following criteria:
- Outpatients between 3.0 and 12.11 years of age inclusive
- Males and females who are physically healthy
- diagnosis of autism based on Diagnostic and Statistical Manual (DSM-IV-TR) criteria, the Autism Diagnostic Interview-Revised, and expert clinical evaluation
- Clinical Global Impression Severity rating of 4
- Care provider who can reliably bring subject to clinic visits, can provide trustworthy ratings, and interacts with subject on a regular basis
- Ability of subject to swallow the compound
- Stable concomitant medications for at least 2 weeks
- No planned changes in psychosocial interventions during the open-label N-Acetyl Cysteine trial
You may not qualify if…
- Diagnostic and Statistical Manual (DSM-IV-TR) diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder, not otherwise specified
- Active medical problems: unstable seizures, significant physical illness (e.g., serious liver or renal pathology)
- Pregnancy or sexually active females
- 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
Where it is running
- Stanford University School of Medicine — Stanford, California, United States
Full record on ClinicalTrials.gov
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