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document
Risperidone treatment of autistic disorder : longer-term benefits and blinded discontinuation after 6 months . OBJECTIVE Risperidone is effective for short-term treatment of aggression , temper outbursts , and self-injurious behavior in children with autism . Because these behaviors may be chronic , there is a need to establish the efficacy and safety of longer-term treatment with this agent . METHOD The authors conducted a multisite , two-part study of risperidone in children ages 5 to 17 years with autism accompanied by severe tantrums , aggression , and/or self-injurious behavior who showed a positive response in an earlier 8-week trial . Part I consisted of 4-month open-label treatment with risperidone , starting at the established optimal dose ; part II was an 8-week randomized , double-blind , placebo-substitution study of risperidone withdrawal . Primary outcome measures were the Aberrant Behavior Checklist irritability subscale and the Clinical Global Impression improvement scale . RESULTS Part I included 63 children . The mean risperidone dose was 1.96 mg/day at entry and remained stable over 16 weeks of open treatment . The change on the Aberrant Behavior Checklist irritability subscale was small and clinically insignificant . Reasons for discontinuation of part I included loss of efficacy ( N=5 ) and adverse effects ( N=1 ) . The subjects gained an average of 5.1 kg . Part II included 32 patients . The relapse rates were 62.5 % for gradual placebo substitution and 12.5 % for continued risperidone ; this difference was statistically significant . CONCLUSIONS Risperidone showed persistent efficacy and good tolerability for intermediate-length treatment of children with autism characterized by tantrums , aggression , and/or self-injurious behavior . Discontinuation after 6 months was associated with a rapid return of disruptive and aggressive behavior in most subjects .
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Intervention_Pharmacological
Risperidone
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Intervention_Pharmacological
Risperidone
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Intervention_Pharmacological
risperidone
22631
Intervention_Pharmacological
risperidone
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Intervention_Control
placebo-substitution
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Intervention_Pharmacological
risperidone
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Intervention_Pharmacological
risperidone
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Intervention_Pharmacological
risperidone ;
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Intervention_Pharmacological
Risperidone
22637
Outcome_Mental
Aberrant Behavior Checklist irritability subscale
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Outcome_Mental
Clinical Global Impression improvement scale
22639
Outcome_Mental
Aberrant Behavior Checklist irritability subscale
22640
Outcome_Other
loss of efficacy
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Outcome_Adverse-effects
adverse effects
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Outcome_Physical
relapse rates
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Outcome_Other
efficacy
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Outcome_Other
tolerability
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Participant_Age
children
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Participant_Condition
autism
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Participant_Age
children
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Participant_Age
5 to 17 years
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Participant_Condition
autism
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Participant_Sample-size
63
22651
Participant_Sample-size
32