DIVALPROEX SODIUM ER IN ADULT 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. Based on positive research with divalproex in children/adolescents with autism, we would like to extend this research to autistic adults with high levels of aggression, irritability, affective instability, or agitation. We aim to have 10 adult autistic patients enrolled in our study of the treatment of aggression/irritability with divalproex sodium ER. This will be an open treatment for adult patients since the previous studies already involved a double-blind divalproex sodium vs. placebo design. This naturalistic design will allow for prior stable (3 months) use of concomitant medications. Our objective is to determine how well these patients can tolerate the prescribed doses and what added benefits can be attributed to divalproex sodium ER. The patients' improvement on irritability/aggression will be assessed on the ABC, CGI, and OAS-M irritability scales. This study will be completed in nine months. Hypothesis: Patients with Autism Spectrum Disorders receiving treatment with Depakote ER will, over 12 weeks: 1. Demonstrate an improvement versus baseline on ratings of global severity 2. Demonstrate an improvement versus baseline decrease in impulsive aggression. 3. Demonstrate an improvement versus baseline on ratings and affective lability.