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. Autism is a developmental disorder characterized by deficits in socialization, communication and repetitive behaviors. Despite extensive studies of several drugs in the treatment of autistic disorder and related pervasive developmental disorders, no drugs have been shown to reliably improve the core social and communication impairment. The purpose of this study is to determine whether D-cycloserine will be efficacious and safe in the treatment of children and adolescents with autism. D-cycloserine is known to have potent neuropsychiatric effects through its action on the N-methyl-D-aspartate (NMDA) subtype of glutamate receptor. Pilot data from our group suggests that this drug may have efficacy in children with autism. This project, when completed, will be the first study to thoroughly evaluate D-cycloserine in autism and will be one of the most comprehensive studies of a glutamatergic agents in autism to date. This information will greatly expand the knowledge about glutamatergic agents in autism and provide crucial information regarding the pathology and future design of drug studies in autism. The central hypothesis of this project is that D-cycloserine will be efficacious in reducing certain symptoms of autism including some aspects of social impairment. Children and adolescents with autism and significant social withdrawal will be randomized to either D-cycloserine or placebo and treated for 8 weeks (phase I). During this trial, subjects will be seen weekly and administered standardized assessments. At the end of 8 weeks, responders to treatment will receive 4 months of additional treatment (phase II). Placebo non-responders will be offered open-label treatment in a study of identical design to phase I. If those subjects respond positively to treatment, they will be offered 4 months of open label treatment as well (phase II). Subjects who respond to placebo or who do not respond positively to D-cycloserine will not participate in Phase II of the study. Safety measures and ratings of adverse effects will be monitored through both phases of the study.
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