Risperidone shows promise as treatment for serious behavioral problems in autistic children


The atypical antipsychotic agent risperidone is successful and well
tolerated as treatment for serious behavioral disturbances associated with autism in children ages 5 to 17 years, according to an article in the August 1st issue of the New England Journal of Medicine. The findings emerged from an eight-week, placebo-controlled clinical trial involving 101 American children.

"Although this study did not attempt to treat the core symptoms of autism, our findings suggest that risperidone can be useful in treating moderate to severe behavior problems that are associated with autism in children," said Lawrence Scahill, Ph.D., principal investigator at one hospital in the multi-site trial.

Autism affects as many as 20 children per 10,000. Although its causes are largely unknown, available evidence implicates abnormalities in brain development and a strong genetic contribution. In addition to core symptoms, children with autism frequently exhibit serious behavioral disturbances such as self-injury, aggression, hyperactivity, and tantrums in response to routine environmental demands. For these disturbances, behavioral therapy and medications are the two main forms of treatment.

In the current, multi-site study, researchers randomly assigned 101 children and
adolescents, 82 boys and 19 girls, age 5 to 17 years, to receive either placebo or
risperidone.

Investigators found risperidone to be significantly more effective than placebo
in improving behavior. Using a stringent definition of improvement, 69 percent of the children randomly assigned to risperidone were much or very much improved at the end of the eight-week study compared with only 12 percent in the placebo group. This is the largest positive effect by a medication ever observed in children with autism.

Risperidone was well tolerated, with few neurological side effects. However,
drug use was associated with a substantial increase in body weight (an
average of about a six-pound increase in the eight-week period).

Several medications have been used to treat autism previously but with limited
success. To date, only haloperidol has been shown to be superior to placebo for serious behavior problems in more than one placebo-controlled study. Concerns about neurological and other side effects of haloperidol cause many clinicians to avoid its use in children.

Few studies of atypical antipsychotic medications have been conducted in children with autism. The primary goal of the current work was to evaluate the efficacy and safety of risperidone, the first widely available atypical antipsychotic agent, in this pediatric population.







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