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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 …