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document
Risperidone versus haloperidol in children and adolescents with AD : a randomized , controlled , double-blind trial . OBJECTIVE The aim of the study was to compare safety , efficacy and tolerability of risperidone with haloperidol in the treatment of Autistic Disorder ( AD ) . METHOD This study was designed as a double-blind , prospective , for a 12-week period . A total of 30 subjects , between the ages of 8 and 18 with AD based on DSM IV criteria , were included in the study . Behavioral Rating Scales were performed by the investigators and the parents . Safety assessment included vital signs , electrocardiogram , electroencephalogram , adverse events , laboratory tests , extrapyramidal symptoms and the side effects . Both treatments were applied in a once daily dosage regimen of 0.01-0.08 mg/kg/day . RESULTS The reduction from baseline in Ritvo-Freeman Real Life Rating Scale ( RF-RLRS ) , sensory motor ( subscale I ) and language ( subscale V ) scores were significant in risperidone group ( P < 0.05 ) . Compared to haloperidol , risperidone led to a significantly greater reduction in the Aberrant Behavior Checklist ( ABC ) and Turgay DSM-IV Pervasive Developmental Disorder ( PDD ) scale scores ( P < 0.05 and P < 0.01 ) . There was a greater increase of prolactin in the risperidone group , while alanine amino transferase ( ALT ) had further increased in the haloperidol group . Sensory motor behaviors ( subscale I ) and language at the end of the 12th week , RF-RLRS sensory motor and language subscale scores decreased in the risperidone group further than the other group ( P < 0.05 ) . CONCLUSIONS Risperidone was found to be more effective than haloperidol in the treatment of behavioral symptoms , impulsivity , language skills , and impaired social relations in children with AD . These results demonstrated that both drugs were safe and well tolerated in the treatment of AD .
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Intervention_Pharmacological
Risperidone
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Intervention_Pharmacological
haloperidol
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Intervention_Pharmacological
risperidone
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Intervention_Pharmacological
haloperidol
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Intervention_Physical
electrocardiogram
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Intervention_Physical
electroencephalogram
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Outcome_Other
safety , efficacy and tolerability
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Outcome_Mental
Behavioral Rating Scales
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Outcome_Mental
Safety assessment
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Outcome_Adverse-effects
vital signs , electrocardiogram , electroencephalogram , adverse events , laboratory tests , extrapyramidal symptoms and the side effects
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Outcome_Mental
Ritvo-Freeman Real Life Rating Scale ( RF-RLRS )
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Outcome_Mental
sensory motor ( subscale I ) and language ( subscale V ) scores
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Outcome_Mental
Aberrant Behavior Checklist ( ABC ) and Turgay DSM-IV Pervasive Developmental Disorder ( PDD ) scale scores
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Outcome_Physical
prolactin
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Outcome_Other
alanine amino transferase ( ALT
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Outcome_Physical
)
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Outcome_Mental
Sensory motor behaviors ( subscale I )
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Outcome_Mental
language
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Outcome_Mental
RF-RLRS sensory motor and language subscale scores
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Outcome_Mental
behavioral symptoms , impulsivity , language skills
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Outcome_Mental
impaired social relations