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document
Long-term effects of risperidone in children with autism spectrum disorders : a placebo discontinuation study . OBJECTIVE The short-term benefit of risperidone in ameliorating severe disruptive behavior in pediatric patients with autism spectrum disorders is well established ; however , only one placebo-controlled , long-term study of efficacy is available . METHOD Thirty-six children with an autism spectrum disorder ( 5-17 years old ) accompanied by severe tantrums , aggression , or self-injurious behavior , started 8-week open-label treatment with risperidone . Responders ( n = 26 ) continued treatment for another 16 weeks , followed by a double-blind discontinuation ( n = 24 ; two patients discontinued treatment because of weight gain ) consisting of either 3 weeks of taper and 5 weeks of placebo only or continuing use of risperidone . Relapse was defined as a significant deterioration of symptoms based on clinical judgment and a parent questionnaire . RESULTS Risperidone was superior to placebo in preventing relapse : this occurred in 3 of 12 patients continuing on risperidone versus 8 of 12 who switched to placebo ( p = .049 ) . Weight gain , increased appetite , anxiety , and fatigue were the most frequently reported side effects . CONCLUSIONS This study indicates the effectiveness of risperidone during a period of several months , reducing disruptive behavior in about half of the children with autism spectrum disorders . The results provide a rationale for the continuing use of risperidone beyond 6 months , although considerable weight gain can limit the use of this agent .
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Intervention_Pharmacological
risperidone
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Intervention_Control
placebo
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Outcome_Mental
severe disruptive behavior
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Outcome_Mental
relapse :
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Outcome_Physical
Weight gain , increased appetite
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Outcome_Physical
anxiety
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Outcome_Physical
fatigue
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Outcome_Mental
disruptive behavior
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Outcome_Physical
weight gain
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Participant_Age
children
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Participant_Condition
autism spectrum disorders
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Participant_Age
pediatric patients
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Participant_Condition
autism spectrum disorders
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Participant_Sample-size
Thirty-six
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Participant_Age
children
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Participant_Condition
autism spectrum disorder
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Participant_Age
5-17
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Participant_Age
children
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Participant_Condition
autism spectrum disorders