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Study Finds Risperidone Safe, Effective as Intermediate Term Autism Treatment

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Posted: 7/1/2005

A multisite study sponsored by the National Institute of Mental Health (NIMH) finds children with autism characterized by tantrums, aggression, and/or self-injury respond favorably to the antipsychotic medication risperidone for up to six months.

Published in the July edition of the American Journal of Psychiatry, the study found the medication not only decreased aggression but also reduced repetitive behaviors and hyperactivity – all with limited side effects. The two-part study also found discontinuation after six months prompted rapid return of disruptive and aggressive behavior in 62 percent of cases.

Atypical antipsychotic medications such as risperidone are of interest to doctors who treat children with autism. This is because studies of other conditions (e.g., schizophrenia) show the newer medications produce clinical benefit with fewer neurological side effects than older options.

“A variety of treatments, including medication and behavior therapy, are used to manage highly disruptive behaviors in youngsters with autism, but controlled medication trials are limited,” said Dr. Michael Aman, site principal investigator at the Ohio State University and director of OSU’s Research Unit on Pediatric Psychopharmacology. “Our findings support adding risperidone to the small arsenal of intermediate-term medication options for the thousands of children with autism who display aggressive and destructive behaviors.

“Because of the need to establish a ‘track record’ for tenure, due to limited funds, and because of other pressures to publish quickly, researchers tend to focus on short-term effects of medicines. What makes this study unique is that our multisite network focused on longer-term needs, benefits and risks associated with the medicine. By and large, we found robust benefits with risperidone and only minor side effects even after six months of treatment,” said Michael Aman, professor of psychology and psychiatry.

Autism is a chronic condition that appears in early childhood. Core symptoms include impaired social interaction, delayed language development and restricted patterns of behavior. The disorder affects as many as 20 in 10,000 children. Although the causes of autism are unknown, scientific evidence points to abnormalities in brain development and a strong genetic component.

In addition to core symptoms, children with autism frequently exhibit serious behavior disturbances in response to routine environmental demands. For these disturbances, behavior therapy and medications are the two main forms of treatment.

In the multisite study, researchers randomly assigned 101 subjects – 82 boys and 19 girls – ages 5 to 17 to receive either placebo or risperidone. Subjects who improved substantially after eight weeks continued treatment for up to six months. Researchers observed a small sample of subjects at the end of the study during the withdrawal of the medication.

Previously, the largest extended studies of medication for autism with haloperidol, an older antipsychotic, showed the drug to be modestly effective but accompanied by neurological and other side effects.

Past research into the effect of risperidone on children with autism found the medication effective for short-term treatment of disruptive behaviors related to autism in children. Side effects of risperidone are usually well-tolerated, with some complaints of weight gain.

The intermediate-term risperidone study was conducted at five sites of the Research Units of Pediatric Psychopharmacology (RUPP) network, which is funded by NIMH. The RUPP network is devoted to conducting studies to test the efficacy and safety of medications commonly used off-label to treat children and adolescents. In clinical practice, many medications are used in the treatment of autism, but few have been carefully studied to determine their safety and effectiveness for the treatment of childhood illnesses.

Principal investigators at the research sites included Drs. Michael G. Aman of Ohio State University, Christopher J. McDougle of Indiana University, James McCracken of UCLA, Lawrence Scahill of Yale University, Elaine Tierney of Kennedy Krieger Institute at Johns Hopkins University, and Benedetto Vitiello of the NIMH. Faculty at Columbia University, Yale University and Nathan Kline Institute participated in data collection, coordination and analysis.

Funding for the study was provided by the National Institute of Mental Health, National Institutes of Health Division of Research Resource General Clinical Research Center at the sites. Study medications were donated by Janssen Pharmaceutica.

The Nisonger Center at Ohio State University is a Center of Excellence for Mental Retardation and Developmental Disabilities. The Nisonger RUPP is one of eight national research units in pediatric psychopharmacology competitively funded by National Institute of Mental Health.

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Emily Caldwell
Medical Center Communications
614.293.3737
caldwell-6@medctr.osu.edu

Behavioral Health; Clinical/Translational Research; Mental Health; OSU Medical Center