"Risperidone Provides Some Improvement in Behavior for Children With Autism: Presented at ECNP"
By Mark Pownall
AMSTERDAM, THE NETHERLANDS -- October 24, 2005 -- Tantrums, aggressive behavior, and self-injury were all reduced in children with severe autism who were treated with the atypical antipsychotic risperidone, according to research presented here.
The 8-week study by the Research Units on Pediatric Psychopharmacology (RUPP) Autism Network, a multicenter collaboration, was presented on October 24[th at the 18th Congress of the European College of Neuropsychopharmacology (ECNP).
The trial is the largest placebo controlled study carried out in autism, Lawrence Scahill, MD, Associate Professor of Nursing and Child Psychiatry, Yale University Child Study Center, New Haven, Connecticut, United States, said in a presentation here on October 23rd.
The researchers enrolled children with a mean age of 8.8 years; 49 children were randomized to risperidone and 52 to placebo. There were no significant differences in the baseline characteristics in the 2 groups.
Responders to treatment were offered treatment for a further 4 months, he said, and the improvements noted were sustained over that period.
Over the 6 months of the 2 stages of the study children gained a mean 5.6kg (+/- 3.9 kg), mostly in the first 2 months of treatment. The gain was 3 to 4 kg more than would be expected, Dr. Scahill said.
The results show a 14-point decrease in the irritability subscale of the Aberrant Behavior Checklist (ABC). The decrease was statistically and clinically significantly superior to the 3.6-point decrease seen in patients on placebo (P < .0001). The fall in the double blind, placebo-controlled study, said the researcher, was 58% in the risperidone-treated group compared with baseline (18% in the placebo-treated group).
There was also a significant improvement in overall clinical improvement as measured by the Clinical Global Improvement investigator (CGI-I) scale, which improved by 75.5% in the risperidone-treated group and by 11.5% for the placebo-treated group, a significant difference.
"Risperidone is an effective treatment for serious behavioral problems in autism, when used in low to moderate doses, and the positive effects are stable over time," Dr. Scahill said. "These were very symptomatic patients and they got dramatically better."
The irritability scores of the autistic children in the study were 25, 2 standard deviations above the mean, Dr. Scahill said. "After treatment, they were within 1 standard deviation of the population mean, their behavior was transformed."
The researchers could not find any predictors for weight gain but said that monitoring and counseling on diet and preventing weight gain was most important in the first 2 months of treatment. "You should not wait until significant weight gain has already happened [before initiating counseling]," he said.
Treatment with risperidone also improved the functioning, he said. Overall, the children, who had a mean age of nearly 9 years, were functioning like a 3-year-old at baseline, he said. But treatment added 6 months to their overall level of functioning. The children were functioning at a mean age of 30 months for socialization, 36 months for communication, and 42 months for daily living, and treatment added 8, 5, and 4 months to these levels of function, respectively.
"Any positive improvement here is probably clinically meaningful," Dr. Scahill commented.
In the third stage of the study -- an 8-week, placebo-controlled, discontinuation study -- patients on treatment were randomized to placebo or a continuation of treatment. Of the 16 patients on placebo, 10 relapsed compared with 2 of 16 on risperidone treatment.
Citation: The Journal of the European College of Neuropsychopharmacology. 2005;15 (suppl 3): S324.
[Presentation title: Risperidone in Autism: Findings from the Research Units on Pediatric Psychopharmacology (RUPP) Autism Network. Abstract S.06.05]
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