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Risperidone was safe and effective for short term treatment of children with autism and serious behavioural disturbances

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 QUESTION: In children with autism and serious behavioural disturbances, is risperidone safer and more effective than placebo?


Randomised (unclear allocation concealment*), blinded (clinicians, patients, and outcome assessors),* placebo controlled trial with 8 weeks of follow up.


5 university centres in the US.


101 children who were 5–17 years of age (mean age 8.8 y, 81% boys), met the DSM-IV criteria for autistic disorder, and presented with tantrums, aggression, or self injurious behaviour. Other inclusion criteria were weight of ≥15 kg, mental age ≥18 months, and no serious medical disorders or other psychiatric disorders requiring medication. Children receiving a psychotropic drug that was effective for aggression, tantrums, or self injurious behaviour were excluded. Follow up was complete.


Patients were allocated to risperidone (n=49) or placebo (n=52). For children who weighed <20 kg, the initial dose …

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  • Sources of funding:National Institutes of Health; Korczak Foundation; Janssen Pharmaceutica.

  • For correspondence: Dr L Scahill, Yale Child Study Center, New Haven, CT, USA. lawrence.scahill{at}

  • * See glossary.

  • CI calculated from data in article.