ARIPIPRAZOLE IN CHILDREN AND ADOLESCENTS WITH AUTISTIC DISORDER

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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. This is an open-label study of the effectiveness, tolerability, and safety of aripiprazole for the treatment of interfering behaviors commonly observed in children and adolescents with autistic disorder. Research suggests that a dysregulation of dopamine and serotonin systems contributes to interfering behaviors in autistic individuals. Because of the increased propensity for adverse effects with typical neuroleptics and the atypical antipsychotics (albeit significantly less), there remains a need for a safe and effective pharmacotherapy for youngsters in this population. Aripiprazole, a partial agonist at the dopamine D2 receptor, may be considered a dopamine system stabilizer. Preliminary research demonstrating efficacy in adult subjects, and more recent research of aripiprazole in youngsters with conduct disorder, found no serious adverse effects. This evidence suggests that aripiprazole may be an ideal compound, regarding effectiveness and tolerability, for autistic individuals. The 14-week study will enroll 20 children and adolescents with autism where subjects will receive 5mg/day of aripiprazole, with the opportunity to increase to a maximum dosage of 15 mg over a 4-week period, as tolerated. After titration, subjects will continue on aripiprazole for an 8-week maintenance period. Response will be determined by ratings of primary outcome measures: the Clinical Global Impression Scale (CGI)-Improvement scale and the irritability subscale of the Aberrant Behavior Checklist (ABC). Adverse effects will be monitored with the Abnormal Involuntary Movement Scale (AIMS), Simpson-Angus Rating Scale, and the Side Effects Review Form. Data will be analyzed with the intent to gain a preliminary understanding of the effectiveness, tolerability, and safety of aripiprazole in children and adolescents with autism. This exploratory study will serve to stimulate more definitive, controlled research.