Risperidone Controls Behavior in Children With Subaverage IQ

Laurie Barclay, MD

August 13, 2002

Aug. 14, 2002 -- Risperidone was effective for the control of disruptive behavior in children with subaverage intelligence, according to results of a double-blind, parallel group study reported in the August issue of the American Journal of Psychiatry.

"The magnitude of effect was quite pronounced," write Michael G. Aman and colleagues from the Risperidone Disruptive Behavior Study Group.

In this six-week, multicenter study, 118 children aged 5 to 12 years with severely disruptive behaviors and IQ between 36 and 84 received 0.02 to 0.06 mg/kg per day of risperidone oral solution or placebo.

On the conduct problem subscale of the Nisonger Child Behavior Rating Form, the risperidone group showed significantly greater improvement than did the placebo group from week 1 through endpoint, with change in score of -15.2 vs. -6.2. The risperidone group also had significantly greater improvement than did the placebo group on all other Nisonger Child Behavior Rating Form subscales; on the Aberrant Behavior Checklist subscales for irritability, lethargy/social withdrawal, and hyperactivity; on the Behavior Problems Inventory aggressive/destructive behavior subscale; on a visual analogue scale of the most troublesome symptom; and on the Clinical Global Impression change score.

Although headache and somnolence were the most common adverse effects linked to risperidone, the beneficial effects of risperidone were independent of the sedative effects. The extrapyramidal symptom profile of risperidone was comparable to that of placebo. Mean weight increases of 2.2 kg and 0.9 kg occurred in the risperidone and placebo groups, respectively. Advantages of risperidone over alternative psychotropic agents include onset of effect within one week and no requirement for blood level monitoring.

"Like all antipsychotics, risperidone should be used cautiously, especially in children whose brains are still developing," the authors write. "Although we observed no sexual adverse events in this trial, we also recommend inquiry and, where appropriate, examination for possible prolactin-related sexual side effects."

The Janssen Research Foundation supported this study.

Am J Psychiatry. 2002;159(8):1337-1346

Reviewed by Gary D. Vogin, MD

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