NOVEL PHARMACOLOGICAL STRATEGIES IN 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. Although there is currently no cure for autism, the appropriate use of medication and psychosocial treatment can reduce many of the associated maladaptive behaviors. Such change often enhances the person's ability to benefit from educational and vocational opportunities and to reside in the least restrictive alternative possible, thus resulting in an improved quality of life for the individual and his or her family. The goal of this study is to evaluate the safety and effectiveness of aripiprazole in children and adolescents with autism who have significant irritability, aggression and/or self injurious behavior. The study also includes an optional addition (for those who qualify) of the medication, D-cycloserine to evaluate its safety and effectiveness for the treatment of social relatedness. The purpose of this study is to find out if aripiprazole is helpful for the treatment of irritability, aggression and/or self-injurious behavior as well as to determine if adding D-cycloserine improves social behavior in children and adolescents with autism. This study will include 88 children and adolescents aged 6 - 17 years. There are several phases in this study: the first phase is a double-blind study lasting approximately eight weeks. Subjects responding to aripiprazole during either the initial double-blind phase or the 8 week open-label trial for those subjects randomized to placebo, will be offered an additional 16 weeks of treatment in Phase II. If the subject continues to respond well, he/she will be allowed to add D-cycloserine to his/her ongoing treatment of aripiprazole for an additional 8 weeks.