Investigational Study Evaluates the Effectiveness of Aripiprazole,in Adolescents With Schizophrenia ( positive and negative subscales andthe...)

Investigational Study Evaluates the Effectiveness of Aripiprazole,in Adolescents With Schizophrenia

positive and negative subscales and the Clinical Global Impression of Improvement (CGI-I) scale. Important safety measures included incidence of adverse events, discontinuation from study due to adverse events, and laboratory measures.

Approximately 85 percent of 302 randomized patients completed this six- week study (83 percent of aripiprazole- and 90 percent of placebo-treated patients). Both doses of aripiprazole demonstrated improvement compared to placebo (p-value less than 0.05) in the mean change from baseline in PANSS Total Score at week six (aripiprazole 10 mg: -26.7; aripiprazole 30 mg: -28.6; placebo: -21.2).

The mean change from baseline to endpoint on PANSS Positive Subscale was: -7.6 for aripiprazole 10 mg (p-value less than 0.05), -8.1 for aripiprazole 30 mg (p-value less than 0.01), and -5.6 for placebo. The mean change from baseline to endpoint on PANSS Negative Subscale was: -6.9 for aripiprazole 10 mg (p-value less than 0.05), -6.6 for aripiprazole 30 mg, and -5.4 for placebo. Improvements were observed in CGI-I [aripiprazole 10 mg: 2.7 (p- value less than 0.05); aripiprazole 30 mg: 2.5 (p-value less than 0.01); placebo: 3.1].

In this study, the overall incidence of discontinuation due to adverse events was 4.3 percent for all treatment groups (5.4 percent of aripiprazole- and 2 percent of placebo-treated patients). The most common adverse events associated with aripiprazole (greater than 5 percent and at least twice the incidence compared to placebo) were extrapyramidal disorder (aripiprazole 10 mg: 13 percent; aripiprazole 30 mg: 21.6 percent; placebo: 5 percent), somnolence (aripiprazole 10 mg: 11 percent; aripiprazole 30 mg: 21.6 percent; placebo: 6 percent), and tremor (aripiprazole 10 mg: 2 percent; aripiprazole 30 mg: 11.8 percent; placebo: 2 percent).

No significant differences were found between aripiprazole and placebo on the Abnormal Involuntary Movement Scale (AIMS) or Barnes Akathisia Rating Scale (BARS). S
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