One of a newer class of antipsychotic medications shows promise for the treatment of serious behavioral disturbances in autistic children, according to a Yale study published in August in the New England Journal of Medicine.
"Although our 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," says Lawrence Scahill, an associate professor at the School of Nursing and the Yale Child Study Center, and the lead author of the study.
Autism is a serious chronic developmental disorder that appears in early childhood. It is characterized by profound impairments in the ability to relate to others, delayed language and restricted patterns of behavior. It affects as many as 20 children per 10,000. Although causes of autism are unknown for most cases, available evidence implicates abnormalities in brain development. Twin and family studies indicate a strong genetic link.
In addition to core symptoms, children with autism frequently exhibit serious behavior disturbances, such as self-injury, aggression and tantrums in response to routine environmental demands. For these disturbances, behavior therapy and medications are the two main forms of treatment.
The multi-site, eight-week, placebo-controlled clinical trial was funded by the National Institute of Mental Health (NIMH) and coordinated at Yale.
Researchers randomly assigned 101 subjects -- 82 males and 19 females, age 5 to 17 -- to receive either placebo or risperidone, one of the new atypical antipsychotic drugs.
The study found risperidone to be significantly more effective than a placebo in improving the serious behavioral problems in this group of children, with 69% of the children who received the medication showing a positive response compared with only 12% in the placebo group. No previous study in autism has shown this large treatment effect, says Scahill.
Risperidone was generally well tolerated. ,Of particular interest, notes the Yale researcher, was the absence of neurological side-effects, which are often seen with traditional antipsychotic medications. Risperidone was associated with an increase in body weight (an average of about six-pound increase in the eight-week period). This was a welcome side-effect for some children and a potential problem for others, notes Scahill.
Several medications have been used previously to treat autism with limited success. To date, only haloperidol has been shown to be superior to placebo for serious behavior problems in more than one study. Concerns about neurological and other side effects of haloperidol cause many clinicians to avoid its use in children, notes the researcher.
According to Scahill, atypical antipsychotics are of great interest in treating children with autism because studies have shown them to be beneficial to adults with schizophrenia, with fewer neurological side effects than older medications.
The study was conducted at five sites of the Research Units of Pediatric Psychopharmacology network, which is funded by NIMH. In addition to Yale, participating institutions included the University of California at Los Angeles; Ohio State and Indiana universities, and the Kennedy Krieger Institute at the Johns Hopkins University.
"This is the largest randomized clinical trial on autism to date," said Scahill. "It lays the groundwork for further research to help families better manage serious behavioral disturbance in children and adolescents with autism."
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