Education and Training
An Open-Label Study of N-Acetyl Cysteine in Children With Autism
The purpose of the study is to test the tolerability and efficacy of N-Acetyl Cysteine (NAC) in children with Autism.
Stanford is currently not accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: N-Acetyl Cysteine
Eligibility
Inclusion Criteria:
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:
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 on 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. Diagnostic and Statistical Manual (DSM-IV-TR) diagnosis of schizophrenia,
schizoaffective disorder, or psychotic disorder, not otherwise specified
2. Active medical problems: unstable seizures, significant physical illness (e.g.,
serious liver or renal pathology)
3. Pregnancy or sexually active females
4. 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
Ages Eligible for Study
3 Years - 12 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Robin Libove
6507361235
Not Recruiting