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document
Risperidone dosing in children and adolescents with autistic disorder : a double-blind , placebo-controlled study . Efficacy and safety of 2 risperidone doses were evaluated in children and adolescents with autism . Patients ( N = 96 ; 5-17 years ) , received risperidone ( low-dose : 0.125 mg/day [ 20 to < 45 kg ] , 0.175 mg/day [ > 45 kg ] or high-dose : 1.25 mg/day [ 20 to < 45 kg ] , 1.75 mg/day [ > 45 kg ] ) or placebo . Mean baseline ( range 27-29 ) to endpoint change in Aberrant Behavior Checklist-Irritability ( primary endpoint ) was significantly greater in the high-dose- ( -12.4 [ 6.5 ] ; p < 0.001 ) , but not low-dose ( -7.4 [ 8.1 ] ; p = 0.164 ) group , versus placebo ( -3.5 [ 10.7 ] ) . Clinical Global Impressions-Severity and Children 's Yale-Brown Obsessive Compulsive Scale scores improved significantly only in the high-dose group , consistent with ABC-I results . Somnolence , sedation and increased appetite occurred more frequently in high-versus low-dose groups . Overall , increased appetite occurred most frequently .
57608
Intervention_Pharmacological
Risperidone
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Intervention_Pharmacological
risperidone
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Intervention_Pharmacological
risperidone ( low-dose
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Intervention_Pharmacological
high-dose
57612
Outcome_Other
Efficacy
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Outcome_Other
safety