What clinical studies support the use of RISPERDAL in children with autistic disorder?
A. In order to evaluate the safety and effectiveness of RISPERDAL for behavioral problems in pediatric patients with autistic disorder, 2 studies of more than 100 patients ages 5 to 16 years were performed. In one of these studies, after 8 weeks of treatment, parents observed a statistically significant 57% improvement in target behaviors, such as aggression, self-injury, tantrums, and quickly changing moods, compared with 14% for placebo. Clinicians confirmed that RISPERDAL provided significant overall improvement. Seventy-six percent of patients treated with RISPERDAL were rated by clinicians as being “much improved” or “very much improved” versus 12% for placebo at Week 8. This study was conducted by the National Institute of Mental Health (NIMH), part of the National Institutes of Health (NIH), and the results were published in the August 2002 issue of The New England Journal of Medicine. The other 8-week study, published in the December 2007 issue of Journal of Autism and Developm
