Status:
COMPLETED
A Study of Oral N-Acetylcysteine in Children With Autism Spectrum Disorders
Lead Sponsor:
Indiana University School of Medicine
Collaborating Sponsors:
National Alliance for Autism Research
Conditions:
Autistic Disorder
Asperger Syndrome
Eligibility:
All Genders
4-12 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine whether treatment with oral N-acetylcysteine (NAC) will improve behavior problems often associated with autism spectrum disorders.
Detailed Description
Autism is increasingly being recognized as a common disorder with enormous public health significance. The core symptoms of autism include severe deficits in social relatedness and communication, and ...
Eligibility Criteria
Inclusion
- Age 4 to 12 years.
- Diagnosis of autistic disorder, Asperger's disorder, or PDD NOS.
- If taking concomitant psychotropic medications, the medication must be at a constant dose for 60 days with no dose changes planned for the duration of the trial.
- Able to swallow capsules.
Exclusion
- Presence of any medical condition that significantly increases risk or hampers assessment (e.g., unstable hypertension or cardiac disease, unstable asthma, kidney disease, unstable seizure disorder, pregnancy or any other medical condition as determined by the investigator).
- Weight \< 15 kg.
- Subjects taking concomitant medications or supplements known for their glutamatergic effects (e.g., dextromethorphan, D-cycloserine, amantadine, memantine, lamotrigine, riluzole) or antioxidant properties (high dose vitamin supplements, DMG, TMG, many alternative treatments) within 30 days of the baseline visit with the exception of short term use of dextromethorphan as needed as a cough suppressant. The use of this medicine must be stopped at least 7 days prior to the baseline visit. Regular multivitamins will be allowed.
- Subjects taking daily acetaminophen or nonsteroidal anti-inflammatory drugs within 30 days of the baseline visit.
- Profound mental retardation as evidenced by a mental age below 18 months.
- Subjects taking concomitant medications with the potential for pharmacokinetic or pharmacodynamic drug-drug interactions (e.g., carbamazepine) within 30 days of the baseline visit.
- Subjects who are likely to experience significant changes in their ongoing psychosocial or medical treatments for autism over the course of the trial (e.g., initiation of new behavioral therapy, initiation of new medication or alternative treatment \[e.g., chelation\]). Minor changes in ongoing treatment (e.g., missed therapy sessions due to holiday/vacation; planned break in therapy due to school holidays) will not be considered significant.
- History of prior treatment with NAC.
- Evidence of hypersensitivity/allergy to NAC.
- Presence of certain neurodevelopmental disorders such as Fragile X Syndrome, Tuberous Sclerosis, or other neurological disorders known to be associated with autism or autistic features.
- Diagnosis of Rett's disorder, childhood disintegrative disorder, schizophrenia, bipolar disorder, another psychotic disorder, or substance abuse disorder.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT00453180
Start Date
March 1 2007
End Date
November 1 2009
Last Update
June 14 2017
Active Locations (1)
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1
Riley Hospital, Riley Child and Adolescent Psychiatry Clinic
Indianapolis, Indiana, United States, 46020