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Risperidone in Children With Disruptive Behavior Disorders and Subaverage Intelligence: A 1-Year, Open-Label Study of 504 Patients

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ABSTRACT

Objective:

To determine the long-term safety and effectiveness of risperidone for severe disruptive behaviors in children.

Method:

A multisite, 1-year, open-label study of patients aged 5 to 14 years with disruptive behaviors and subaverage intelligence was conducted.

Results:

Seventy-three percent of the 504 patients enrolled completed the study. The mean ± SE dose of risperidone was 1.6 ± 0.0 mg/day. The most common adverse events were somnolence (30%), rhinitis (27%), and headache (22%). The incidence of movement disorders was low, and mean Extrapyramidal Symptom Rating Scale scores decreased during risperidone treatment. No clinically significant changes in mean laboratory values were noted, except for a transient increase in serum prolactin levels. Scores on the Nisonger Child Behavior Rating Form Conduct Problem Scale improved significantly as early as week 1, and improvement was maintained throughout the trial (p < .001 at each time point). Significant improvements were noted on positive social behavior and other Nisonger Child Behavior Rating Form subscales, Aberrant Behavior Checklist, Clinical Global Impressions scale, and tests of patients’ cognitive function (each p < .001).

Conclusions:

Risperidone was well tolerated and effective in the long-term treatment of disruptive behavior disorders in children with subaverage intelligence.

Section snippets

METHOD

This 1-year, open-label, international trial was conducted at 32 sites in 12 countries across Europe (n = 16), North America (n = 11), and South Africa (n = 5). Sites chosen were those with extensive experience in the assessment and treatment of children with conduct disorders and with a sufficient number of potential subjects. Investigators included child and adolescent psychiatrists, pediatricians, and clinical psychologists experienced in treating the types of patients enrolled in the study.

RESULTS

Baseline characteristics and patient disposition are shown in Table 1. The patients’ mean age at baseline was 9.7 ± 2.5 years. Most patients had a primary diagnosis of conduct disorder (45%) or oppositional defiant disorder (36%) with or without attention deficit hyperactivity disorder. Mean IQ was 64.2 ± 13.4, and mean Vineland Adaptive Behavior Scale score at baseline was 52.7 ± 13.4.

Of the 589 patients recruited, 504 entered the trial. Reasons for not receiving study medication included

DISCUSSION

The principal and clinically relevant finding of this study of more than 500 children and adolescents with disruptive behavior disorders is that 1 year of treatment with risperidone was generally safe and effective. Risperidone was well tolerated and substantially reduced the severity of disruptive behavior. Over the course of the 1-year study, scores on the N-CBRF, Aberrant Behavior Checklist, and visual analog scale of most troublesome symptoms were significantly reduced from baseline. One

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    This research was supported by Johnson & Johnson Pharmaceutical Research and Development, Beerse, Belgium. The authors thank Sigrid Versele, Alain Schotte, Shulamit Gelerstein, Willem Kriel, Ben Lyons, Ilse Van Hove, and Philippe Lechat for their valuable contribution in conducting the trial and analyzing the data. The authors also thank the members of the Risperidone Disruptive Behavior Study Group for their skilled participation in this year-long study.

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    Copyright © 2005 The American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.