Divalproex Sodium vs. Placebo in Childhood/Adolescent Autism

Meets DSM-IV, ADI, and ADOS criteria for autistic disorder Age 5-17. Outpatients Parent/legal guardian signing informed consent, and assent documented for patient with demonstrated capacity to provide it. Sexually active females of childbearing potential must use an acceptable method of birth control (oral contraceptive medications \[the administration of which must be supervised by a parent or guardian\], IUD, depot medication or tubal ligation) and have a negative serum pregnancy test prior to entry into the study. Subject scores at least "4" (moderately ill) on the Clinical Global Impression-Severity Scale for Autistic Disorder (CGI-AD). Subject meets the following criteria at pre-study diagnostic assessment and baseline assessment: OAS-M 13 or ABC-Irritability Subscale 18 (raw scores). Subjects with history of seizures, who have been seizure-free for 6 months on a stable dose of anticonvulsant medication other than divalproex sodium or related formulations (e.g., depakene). Non-medicated subjects with a history of seizures who have been seizure-free for 6 months. Subjects with abnormal EEG but no clinical seizures. State exclusion criteria for enrollment in study: Subjects who are pregnant or nursing mothers. Sexually active women of childbearing potential who are not using adequate birth control measures (detailed above in inclusion criteria). Subjects with overall adaptive behavior scores below the age of two years on the Vineland Adaptive Behavior Rating Scal…