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Sponsors and Collaborators: |
Indiana University School of Medicine National Alliance for Autism Research |
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Information provided by: | Indiana University |
ClinicalTrials.gov Identifier: | NCT00453180 |
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.
Condition | Intervention | Phase |
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Autistic Disorder Asperger Syndrome Child Development Disorders, Pervasive |
Drug: N-acetylcysteine Drug: Placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Pilot Study of Oral N-Acetylcysteine in Children With Autism Spectrum Disorders |
Estimated Enrollment: | 32 |
Study Start Date: | March 2007 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Target dose for n-acetylcysteine is 60 mg/kg/day. Capsules available in 300 mg and 600 mg strengths.
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Drug: N-acetylcysteine
Capsules available in 300 mg or 600mg strength. Target dose of n-acetylcysteine will be 60mg/kg/day TID. Dosage will be increased to this target dose from week 1 to week 3 barring side effects. Dose reduction will be allowed at any time for adverse side effects. Maximum dose of n-acetylcysteine will be 4200mg/day. |
2: Placebo Comparator
Subjects randomized to placebo arm will receive capsules identical in size and appearance to those subjects receiving study drug. Placebo capsules contain in active ingredients.
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Drug: Placebo
Subjects randomized to placebo arm will receive placebo pill for duration of study.
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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 interfering repetitive behavior. No medications have been shown to consistently improve any of these symptoms.
The central hypothesis of this study is that NAC will improve behavioral manifestations of autism which may include core or associated symptoms. We plan to test our hypothesis and complete the objectives of this project by pursuing the following specific aims:
Ages Eligible for Study: | 4 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jennifer Mullett, RN, CCRP | 317-274-1981 | mullettj@iupui.edu |
Contact: David J Posey, M.D., M.S. | 317-274-8162 | kidpsych@iupui.edu |
United States, Indiana | |
Riley Hospital for Children - Christian Sarkine Autism Treatment Center | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact: Clinic email kidpsych@iupui.edu |
Principal Investigator: | David J Posey, M.D., M.S. | Indiana University School of Medicine |
Responsible Party: | Indiana University School of Medicine ( David J. Posey, M.D., M.S. ) |
Study ID Numbers: | 0611-10 |
Study First Received: | March 27, 2007 |
Last Updated: | July 31, 2009 |
ClinicalTrials.gov Identifier: | NCT00453180 History of Changes |
Health Authority: | United States: Institutional Review Board |
Autistic Disorder Asperger's PDD NOS Pervasive Developmental Disorder Autism N-acetylcysteine acetylcysteine NAC |
antioxidant treatment core symptoms Autism Spectrum Disorders Autistic Disorder Asperger's Disorder Pervasive Developmental Disorder Not Otherwise Specified Pervasive Developmental Disorders |
Developmental Disabilities Anti-Infective Agents Antioxidants Asperger Syndrome Antiviral Agents Child Development Disorders, Pervasive Autistic Disorder |
Mental Disorders Expectorants Mental Disorders Diagnosed in Childhood Acetylcysteine Autism N-monoacetylcystine |
Developmental Disabilities Anti-Infective Agents Respiratory System Agents Antioxidants Disease Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Asperger Syndrome Protective Agents Antiviral Agents Pharmacologic Actions Child Development Disorders, Pervasive |
Pathologic Processes Autistic Disorder Mental Disorders Therapeutic Uses Syndrome Expectorants Free Radical Scavengers Mental Disorders Diagnosed in Childhood Acetylcysteine N-monoacetylcystine Antidotes |