[Niaprazine in behavior disorders in children. Double-blind comparison with placebo]

Abstract

The results of a randomized, double blind clinical trial are described. Niaprazine (1.5 mg/kg/day) or placebo were administered for 1 month to 20 patients (17 M-3 F; age range 6-11 years) suffering from behaviour disorders. Both the active drug and placebo induced an improvement of behaviour in the various conditions assessed in the family, during the play, at school, in the doctor's office but the percent variation induced by niaprazine was always higher than that with placebo (mean -49.4% vs. -24.6). The difference between the treatments was highly significant. No relevant side effects were observed: only in two cases treated with niaprazine the daily dose was reduced due to drowsiness. The authors conclude confirming the therapeutic efficacy of niaprazine in the treatment of behaviour disorders.