Confirmatory study of DSP-5423 in pediatric patients with schizophrenia.

In pediatric patients with schizophrenia, the primary endpoint was the change in total PANSS score from baseline at week 6, and superiority of DSP-5423 8 or 16 mg/day to placebo was examined. The superiority of the 16 mg/day group was verified. Although the superiority was not verified in the 8 mg/day group, the PANSS total score change was greater than that in the placebo. The incidence of adverse events increased in the order of placebo, 8 and 16 mg/day. Most of adverse events were mild or moderate.