An open-label extension study of the safety and efficacy of risperidone in children and adolescents with autistic disorder.

ABSTRACT:

Objective

The purpose of this study was to evaluate the long-term safety and efficacy of risperidone in treating irritability and related behaviors in children and adolescents with autistic disorders.

Methods

In this 6 month (26 week) open-label extension (OLE) study, patients (5-17 years of age, who completed the previous fixed-dose, 6 week, double-blind [DB] phase) were flexibly dosed with risperidone based on body weight. The maximum allowed dose was 1.25 mg/day for those weighing 20 to <45 kg, and 1.75 mg/day for those weighing ≥ 45 kg. The study primarily assessed risperidone's safety; efficacy was assessed as a secondary end-point.

Results

Fifty-six (71%) out of 79 enrolled patients completed the OLE; the most common discontinuations were for insufficient respon

SUBMITTER: Kent JM 

PROVIDER: S-EPMC3870601 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature