Long-Term Safety and Efficacy of Risperidone for the Treatment of Disruptive Behavior Disorders in Children With Subaverage IQs

Abstract

ABSTRACT. Objective. The objective of this study was to investigate the long-term safety and efficacy of risperidone in disruptive behavior disorders in children with subaverage IQs. Disruptive behavior disorders were defined as oppositional defiant disorder, disruptive behavior disorder, and conduct disorder as per the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria.Methods. This was a 48-week open-label (OL) extension study of risperidone in 77 children diagnosed with a disruptive behavior disorder, and either borderline intellectual function or mild or moderate mental retardation who had participated in a previous 6-week, double-blind (DB) study and completed at least 2 weeks of DB therapy. Children, aged 5 to 12 years inclusive, who had: 1) a DSM-IV Axis I diagnosis of conduct disorder, oppositional defiant disorder, or disruptive behavior disordernot otherwise specified; 2) a parent-assessed rating of >24 in the Conduct Problem Subscale of the NisongerChild Behavior Rating Form 28 ; 3) a DSM-IV Axis II diagnosis of mild or moderate mental retardation or borderline intellectual functioning with an IQ >36 and <84; and 4) a score of <84 on the Vineland Adaptive Behavior Scale. Participants received oral solution risperidone given at a once daily dose of between 0.02 and 0.06 mg/kg for a maximum of 48 weeks. Participants in the DB study who had been randomized would have had a maximum of 54 weeks of risperidone therapy. Study visits were scheduled at entry, weekly for the first month, and monthly for the remaining 11 months.Results. Baseline scores on the conduct problem subscale at the start of the previous DB study were similar for both treatment groups: mean values of 33.5 and 33.3 were recorded for placebo-and risperidone-treated participants, respectively. At the time of the OL baseline visit, mean Conduct Problem Subscale scores were lower in those who had been treated with risperidone than in those who remained risperidone-naïve (17.5 and 26.1, respectively). Within 1 week of receiving daily risperidone therapy (mean daily dose: 1.38 mg), those participants who had been risperidone-naïve at OL entry showed a rapid improvement in the Conduct Problem Subscale score. At the week 1 assessment, the mean change from baseline for those who had been risperidone-naïve at OL entry was similar in magnitude to the change from DB baseline recorded for participants who had received risperidone in the DB study. This mean improvement was sustained in both groups throughout the remainder of the OL study.At study endpoint, those participants who had been risperidone-naïve at OL entry experienced a highly significant mean decrease from OL baseline in the mean Conduct Problem Subscale score of 10.6 ؎ 2.18. The response to risperidone in the OL trial remained stable in those participants who had been treated with risperidone in the previous DB trial; in this group, the mean change at study endpoint from OL baseline was a nonsignificant decrease of 1.26 ؎ 1.45. At DB baseline, 68% of pa...

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