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document
Risperidone in the treatment of disruptive behavioral symptoms in children with autistic and other pervasive developmental disorders . OBJECTIVE To investigate the efficacy and safety of risperidone for the treatment of disruptive behavioral symptoms in children with autism and other pervasive developmental disorders ( PDD ) . METHODS In this 8-week , randomized , double-blind , placebo-controlled trial , risperidone/placebo solution ( 0.01-0.06 mg/kg/day ) was administered to 79 children who were aged 5 to 12 years and had PDD . Behavioral symptoms were assessed using the Aberrant Behavior Checklist ( ABC ) , Nisonger Child Behavior Rating Form , and Clinical Global Impression-Change . Safety assessments included vital signs , electrocardiogram , extrapyramidal symptoms , adverse events , and laboratory tests . RESULTS Subjects who were taking risperidone ( mean dosage : 0.04 mg/kg/day ; 1.17 mg/day ) experienced a significantly greater mean decrease on the irritability subscale of the ABC ( primary endpoint ) compared with those who were taking placebo . By study endpoint , risperidone-treated subjects exhibited a 64 % improvement over baseline in the irritability score almost double that of placebo-treated subjects ( 31 % ) . Risperidone-treated subjects also exhibited significantly greater decreases on the other 4 subscales of the ABC ; on the conduct problem , insecure/anxious , hyperactive , and overly sensitive subscales of the Nisonger Child Behavior Rating Form ( parent version ) ; and on the Visual Analog Scale of the most troublesome symptom . More risperidone-treated subjects ( 87 % ) showed global improvement in their condition compared with the placebo group ( 40 % ) . Somnolence , the most frequently reported adverse event , was noted in 72.5 % versus 7.7 % of subjects ( risperidone vs placebo ) and seemed manageable with dose/dose-schedule modification . Risperidone-treated subjects experienced statistically significantly greater increases in weight ( 2.7 vs 1.0 kg ) , pulse rate , and systolic blood pressure . Extrapyramidal symptoms scores were comparable between groups . CONCLUSIONS Risperidone was well tolerated and efficacious in treating behavioral symptoms associated with PDD in children .
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Intervention_Pharmacological
Risperidone
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Intervention_Pharmacological
risperidone
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Intervention_Pharmacological
risperidone/placebo
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Intervention_Pharmacological
risperidone
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Intervention_Pharmacological
risperidone-treated
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Intervention_Control
placebo-treated
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Intervention_Pharmacological
Risperidone-treated
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Intervention_Pharmacological
risperidone-treated
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Intervention_Control
placebo
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Intervention_Pharmacological
risperidone
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Intervention_Control
placebo
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Intervention_Pharmacological
Risperidone-treated
19270
Intervention_Pharmacological
Risperidone
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Outcome_Mental
Aberrant Behavior Checklist ( ABC )
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Outcome_Mental
mean decrease on the irritability subscale of the ABC
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Outcome_Mental
irritability score
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Outcome_Mental
4 subscales of the ABC
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Outcome_Mental
conduct problem , insecure/anxious , hyperactive , and overly sensitive subscales of the Nisonger Child Behavior Rating Form ( parent version )
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Outcome_Adverse-effects
Somnolence
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Outcome_Physical
weight
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Outcome_Physical
pulse rate , and systolic blood pressure
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Participant_Condition
children with autistic and other pervasive developmental disorders .
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Participant_Age
children
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Participant_Condition
autism and other pervasive developmental disorders ( PDD
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Participant_Sample-size
79
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Participant_Age
children
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Participant_Age
aged 5 to 12 years
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Participant_Condition
PDD