EFFECT OF FLUOXETINE ORALLY DISSOLVING TABLET (ODT) ON REPETITIVE BEHAVIORS

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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. 11/27/2007 Hypothesis: This randomized, double-blind, placebo-controlled, parallel-group, 14-week multicenter study will investigate the effect of fluoxetine orally dissolving tablet (ODT) on the repetitive behaviors core domain in children and adolescents with autistic spectrum disorder (ASD). The study will also investigate the effect of fluoxetine ODT on the improvement of symptoms (measured principally through parent report to the evaluator and through evaluator observation) and the effects on daily living on the patient's family (burden, feelings and related items). The primary objective for the study is to evaluate the effects of titrated doses of once-daily oral fluoxetine ODT in a multicenter setting on the repetitive behavior domain in children and adolescent patients with ASD as measured by the mean percent change from baseline in the compulsion subscale of the CYBOCS-PDD compared to placebo at Week 14 or the last assessment. Secondary objectives for the study are to evaluate the time- and dose-related course of therapeutic effects, the inter-relationships between these effects in the context of global clinical changes, and the indirect effects on patient caregivers of titrated doses of once-daily oral fluoxetine ODT in children and adolescent patients with ASD compared to placebo during 14 weeks of drug treatment in a multicenter setting.