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[Niaprazine in behavior disorders in children. Double-blind comparison with placebo]
E Franzoni1, P Masoni, M Mambelli
1Clinica Pediatrica I, Università di Bologna, Italia.
Insights
Niaprazine effectively treats behavior disorders in children. This randomized trial showed significant improvements compared to placebo, with minimal side effects like drowsiness.
Area of Science:
- Pediatric Psychiatry
- Clinical Pharmacology
Background:
- Behavioral disorders are prevalent in children.
- Effective and safe treatment options are needed.
Purpose of the Study:
- To evaluate the efficacy and safety of niaprazine in treating childhood behavior disorders.
Main Methods:
- A randomized, double-blind, placebo-controlled trial.
- 20 children (6-11 years) with behavior disorders received niaprazine (1.5 mg/kg/day) or placebo for 1 month.
Main Results:
- Niaprazine showed a significantly higher improvement in behavior (-49.4%) compared to placebo (-24.6%).
- Improvements were observed across various settings including home, school, and play.
- Minimal side effects were noted, with drowsiness occurring in two cases.
Conclusions:
- Niaprazine is a therapeutically effective option for childhood behavior disorders.
- The drug demonstrates a favorable safety profile.
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.