Autism is a complex neurodevelopmental disorder that is thought to involve an interaction
between multiple and variable susceptibility genes, environmental factors, and epigenetic
effects. Great concern has been raised about the marked increase in the prevalence of autism
spectrum disorders in the last decade. Risperidone, the most studied atypical antipsychotic
used in children, has been shown to improve severe behavioral difficulties in over half of
children with autism who have these difficulties. However, not all children with autism and
severe behavioral problems respond to risperidone, and for a few, it has significant side
effects.
Two controlled studies and numerous open-label and long term studies in children with autism
spectrum disorders using the atypical antipsychotic risperidone show a significant decrease
of associated serious behavioral problems. The use of atypical antipsychotics is of great
concern, however, because of their significant side effects and the fact that only two-thirds
of children positively respond. Ways to predict response, appropriate dosage and serious side
effects are needed.
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
University of California, San Francisco
Collaborators:
Janssen, LP National Institute of Mental Health (NIMH)