Treating autism in children

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Treating autism in children
(Monday, 31st March 2003)

Study finds risperidone effective

According to research carried out in the US, a drug called risperidone is a safe and effective treatment for children who suffer from autism with serious behaviour problems.

The authors reached this conclusion after carrying a study involving 101 children with autistic disorder accompanied by other behaviour problems, such as tantrums and aggression. In the first part of the study half the children received risperidone while the others were given a matching tablet containing an inactive substance.

After eight weeks, children given the inactive tablet who had not improved were put onto risperidone for four months. At the same time, those who had already received the drug and responded well kept taking it for a further four months. At eight weeks, children in the risperidone group showed marked improvements in behaviour (which were maintained for six months) compared with those given the inactive tablet.

The researchers noted that, during the trial, children on risperidone tended to put on more weight than the other children and that they reported feeling more hungry than usual.

Full review:

Research carried out in the US has shown that the antipsychotic drug risperidone is a safe and effective treatment for tantrums, aggression, and self-injurious behaviour in children with autistic disorder. The drug also improved stereotypical behaviour and hyperactivity.

To evaluate the safety and efficacy of risperidone in autistic children with serious behavioural disturbances, the authors conducted an eight-week double-blind, randomised, placebo-controlled trial at multiple sites. Subjects were 101 children, aged from five to 17 years, with a diagnosis of autistic disorder accompanied by various behavioural problems. At the end of the double-blind phase, children in the placebo group who had shown no improvement were offered open-label treatment with risperidone, as were those in the risperidone group who had shown a positive response to the drug. Open-label treatment was continued for four months. Main outcome measures were scores on the Irritability subscale of the Aberrant Behaviour Checklist and the rating on the Clinical Global Impressions scale at eight weeks.

The study showed:

At eight weeks, children in the risperidone group had a 56.9% decrease in mean Irritability score, compared with a 14.1% decrease in the placebo group
The rate of a positive response (defined as a 25% improvement in the score on the Irritability scale and a rating of much or very much improved on the Global Impressions scale) was 69% in the risperidone group and 12% in the placebo group
Scores on the Social Withdrawal Scale, which rates social isolation and interest in communicating with others, did not differ significantly between the two groups
The gains in the risperidone group were maintained for six months in 68% of the children
Children in the risperidone group put on more weight than children in the placebo group, which was accompanied by a mild or moderate increase in appetite
There were no serious adverse events in the risperidone group.

The researchers commented that 'the short period of this trial limits inferences about adverse effects such as tardive dyskinesia.'

REF: Research Units on Pediatric Psychopharmacology Autism Network. Risperidone in children with autism and serious behavioural problems. N Engl J Med 2002; 347: 314-21

New England Journal of Medicine website
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