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Risperidone Appears Safe, Effective in Children With Severe Disruptive Behaviours and Below-Average Intelligence

Risperidone at doses up to 0.06 mg/kg/day appears to be well tolerated and may have long-term effectiveness in children with severe disruptive behaviour disorders and subaverage intelligence, new research suggests.

Previous studies in children have demonstrated an association between risperidone and improvement in target behaviours related to disruptive behaviour disorders, non-specific behaviour problems or self-injurious behaviour, and pervasive developmental disorders.

To examine the long-term safety and efficacy of risperidone in children with both disruptive behaviour and subaverage intelligence, Robert L. Findling, MD, and colleagues of the Department of Psychiatry, Case Western Reserve University, University Hospital of Cleveland, Ohio, United States, performed a 48-week, open-label extension study in children who were previously enrolled in a 6-week, multicentre, double-blind, placebo-controlled risperidone trial.

A total of 107 children, ages 5 to 12 years, who completed 2 or more weeks of the initial trial were included in the extension study. All subjects were diagnosed with severe disruptive behaviour disorders and borderline intellectual functioning or mental retardation according to Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria, and a score of 24 or higher on the conduct problem subscale of the Nisonger Child Behaviour Rating Form.

Patients received 0.02-0.06 mg/kg/day of oral risperidone and other concomitant medications were not permitted, with the exception of anticholinergic medications for extrapyramidal symptoms and the continuation of psychostimulant medications for attention deficit hyperactivity disorder.

Safety was evaluated on days 1, 7, 14, 21, and 28, and every 4 weeks from weeks 8 through 48. Cognitive function was assessed at baseline and at weeks 24 and 48 by using a verbal learning task and a 2-version continuous performance task. The Nisonger Child Behaviour Rating Form was used to score DSM-IV symptoms of disruptive behaviour disorders at baseline and end of the extension study.

Results showed that risperidone was associated with rapid, significant improvement in conduct measures in patients who received placebo in the initial study. Furthermore, improvement was maintained during long-term treatment in patients regardless of previous risperidone treatment.

Approximately 91% of patients experienced adverse events, including somnolence (33%), headache (33%), rhinitis (28%), and weight gain (21%). Additionally, transient and asymptomatic increases in mean prolactin levels were observed. There were no other clinically relevant mean changes in measures of body temperature, pulse rate, respiration rate, blood pressure, ECG parameters, haematology, urinalysis, growth hormone levels, or clinical chemistry.

"Given these findings and the chronic nature of these conditions, further study is warranted to assess the safety and efficacy of risperidone in pediatric patients treated for more than 1 year," the researchers concluded.

Am J Psychiatry 2004 Apr;161;4:677-84. "Long-Term, Open-Label Study of Risperidone in Children With Severe Disruptive Behaviors and Below-Average IQ"

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