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Risperidone Linked to Several Improvements in Children With Autism: Presented at AACAP

By Paula Moyer

WASHINGTON, DC -- October 22, 2004 -- Children with autism who are treated with risperidone (Risperdal) experience a significant improvement in their behavioral symptoms, according to findings presented here October 21^st at the American Academy of Child and Adolescent Psychiatry 51^st Annual Meeting.

"Low-dose risperidone is efficacious and well tolerated in pediatric patients with autism," said Gahan Pandina, PhD, Associate Director, CNS Clinical Development, Janssen Medical Affairs, Titusville, New Jersey. "There was no difference between the groups' extrapyramidal symptoms score before and after treatment."

He and his co-investigators analysed data from a large double-blind study of children with diverse pervasive developmental disorders. The 55 patients in the current research were children 5 to 12 years old who had autism as characterised by the Diagnostic and Statistical Manual-IV.

Children were randomised to two 8-week regimens: 27 received risperidone and 28 received placebo. Those in the risperidone group were titrated upward so that by the study's end, they received an average dose of 0.04 mg/kg/day. They were evaluated using the Aberrant Behavior Checklist (ABC), the Clinical Global Impressions-Change (CGI-C) scale, and the Extrapyramidal Symptom Rating Scale (ESRS).

The 43 boys and 12 girls were an average of 7.3 years old; 62% white, and had an average IQ of 55.5.

The investigators documented significantly greater improvements with risperidone. Improvements included decreases in the ABC irritability subscale, with an average decrease of 13.4 in treated patients and 7.2 in placebo patients (P < .001). On the lethargy and social withdrawal subscale, risperidone patients had an average ABC decrease of 7.7 compared to 4.1 in the placebo group (P < .05). On the hyperactivity subscale, treated patients had an average decrease of 16.1 compared to 7.1 with placebo (P < .001).

By the study's end, CGI-C improvements were significantly greater with risperidone than placebo (P < .001). There was a significantly higher rate of response in the treated patients, which was defined as at least a 25% improvement in the ABC irritability score and CGI-C score of "much improved." The response rate by the study's end was 58.3% in the risperidone group and 21.4% in the placebo group (P = .008).

Average ESRS scores were low at baseline and not significantly changed at end point, Dr. Pandina said. These symptoms developed in two risperidone-treated patients, while one placebo patient developing tardive dyskinesia. The most common adverse event was somnolence, which occurred in 74.1% of treated patients and in 7.1% of placebo patients.


[Presentation title: "Risperidone Improves Symptoms in Children With Autism." Abstract B56]

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