Abstract

Aripiprazole is a novel atypical antipsychotic that is approved in the US for use in adolescents with schizophrenia. In adolescents with schizophrenia, oral aripiprazole 10 or 30 mg/day lead to significantly greater reductions than placebo in the Positive and Negative Syndrome Scale (PANSS) total score from baseline to 6 weeks, according to findings from a randomized, double-blind, multicenter trial (n = 302). In addition, aripiprazole 10 or 30 mg/day recipients had significantly greater improvements in the PANSS positive subscale and Clinical global Impression-Severity and -Improvement scale scores than placebo recipients, and a significantly greater improvement in the PANSS negative subscale score was seen with aripiprazole 10 mg/day than with placebo. Aripiprazole was generally well tolerated in adolescents with schizophrenia, with most adverse events being of mild to moderate severity. Clinically significant weight gain (> or = 7% as defined by the US FDA) occurred in 4.0% of aripiprazole 10 mg/day recipients, 5.2% of aripiprazole 30 mg/day recipients, and 1% of placebo recipients. The mean weight change was significantly different in aripiprazole and placebo recipients (0, +2, and -0.8 kg in aripiprazole 10 mg/day, aripiprazole 30 mg/day, and placebo recipients, respectively).