Status:
COMPLETED
An Open-Label 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.
Detailed Description
N-Acetyl Cysteine (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 antiox...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00676195
Start Date
June 1 2008
End Date
June 1 2010
Last Update
March 29 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Stanford University School of Medicine
Stanford, California, United States, 94305