DIVALPROEX SODIUM VS PLACEBO IN CHILD/ADOLESCENT AUTISM

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The proposed study is designed to assess the efficacy of treatment with divalproex sodium (DS) vs. placebo in childhood/adolescent autism fulfilling DSM-IV and Autism Diagnostic Interview (ADI) criteria. Currently, there are no FDA-approved treatments for this disorder, although behavioral and educational therapies and a variety of medications may play a role in the management of some autistic symptoms. Our study will be a 12-week placebo-controlled, double-blind trial of Divalproex sodium versus placebo in 40 autistic spectrum disorder children and adolescents ages 5-17 years who meet DSM-IV, ADI, and ADOS criteria for autistic disorder. The patients will be recruited from the outpatient pediatrics and adolescent clinics at Mt. Sinai as well as through advertisements and local media.