Status:
COMPLETED
A Study of N-Acetyl Cysteine in Children With Autism
Lead Sponsor:
Stanford University
Conditions:
Autistic Disorder
Eligibility:
All Genders
3-12 years
Phase:
PHASE2
Brief Summary
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 antiox...
Eligibility Criteria
Inclusion
- Outpatients between 3.0 and 12.11 years of age inclusive
- Males and females who are physically healthy
- diagnosis of autism based 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
Exclusion
- DSM-IV-TR diagnosis of schizophrenia, schizoaffective disorder, or psychotic disorder not otherwise specified
- Prior adequate trial of N-Acetyl Cysteine
- 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
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT00627705
Start Date
February 1 2008
End Date
September 1 2010
Last Update
May 18 2017
Active Locations (1)
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1
Stanford University School of Medicine
Stanford, California, United States, 94305