A DOUBLE BLIND, PLACEBO CONTROLLED TRIAL OF ARIPIPRAZOLE IN CHILDREN AND ADOLES

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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. 0135 This study addresses important public health and quality of life concerns regarding the treatment of children and adolescents with Tourette's Disorder (TD) and the associated comorbid psychiatric disorders. To date, the only formally approved treatments for TD are haloperidol and pimozide, typical neuroleptic agents known to have significant and unwanted side effects such as tardive dyskinesia, weight gain and cognitive blunting (Green, 2001). In addition, there is little data on the treatment of comorbid psychiatric disorders in TD. Thus, more efficacious and tolerable treatments are needed. There is some preliminary evidence that aripiprazole can reduce aggression in youth with conduct disorder in low-moderate doses, and was well tolerated (Findling et al., 2003). Aripiprazole has a unique mechanism of action, characterized by partial agonist-antagonist effects on the dopamine and serotonin systems. Therefore, there is a theoretical basis to anticipate that aripiprazole will ameliorate both explosive outbursts and tics in youth with TD. Preliminary data obtained in a case series by the co-investigators has suggested that aripiprazole is effective and reasonably well tolerated as a treatment for both tics and explosive outbursts in young individuals with Tourette's Disorder. This proposal will address this potentially exciting treatment for youth with TD and explosive outbursts.