Long-Term, Open-Label Study of Risperidone in Children With Severe Disruptive Behaviors and Below-Average IQ

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Abstract
OBJECTIVE: This study determined the long-term safety and effectiveness of risperidone in treating severe disruptive behavior in children with subaverage intelligence. METHOD: This 48-week, open-label extension included 107 children ages 5–12 years with severe disruptive behavior disorders (according to DSM-IV criteria and a score of ≥24 on the conduct problem subscale of the Nisonger Child Behavior Rating Form) and subaverage intelligence (IQ 36–84) who completed at least 2 weeks of a randomized, double-blind, placebo-controlled study of risperidone. All patients received 0.02–0.06 mg/kg/day of oral risperidone; the purpose was to accumulate long-term safety data. Scores on the Nisonger Child Behavior Rating Form were also obtained. RESULTS: The mean risperidone dose was 1.5 mg/day. The most common adverse events reported were somnolence (33%), headache (33%), rhinitis (28%), and weight gain (21%). Somnolence was usually mild and transient. The mean weight increase was 5.5 kg; half was attributable to de...

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