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document
Comparison of long-term efficacy and safety of risperidone and haloperidol in children and adolescents with autistic disorder . An open label maintenance study . BACKGROUND The aim of the study was to investigate safety , efficacy and tolerability of risperidone in comparison with haloperidol in the long-term treatment of autistic disorder . METHODS This was an open-label continuation study of the randomized , double-blind , controlled trial of risperidone and haloperidol study for 12 week in autistic children and adolescents . A total of 28 subjects between 8 and 18 ages with autistic disorder were enrolled to the open label phase of the study . Behavioral rating scales ( Clinical Global Impression Scale [ CGI-I ] , Ritvo-Freeman Real Life Rating Scale [ RF-RLRS ] ) , Aberrant Behavior Checklist [ ABC ] , Turgay DSM-IV Pervasive Developmental Disorder Rating Scale [ TPDDRS ] ) and safety assessment scales ( Extrapyramidal Symptoms Rating Scale [ ESRS ] , UKU-Side Effect Rating Scale ) were performed at 12 , 16 , 20 and 24 weeks , following the 12 week double-blind phase . Risperidone and haloperidol treatments were applied with a once daily dosage regimen as 0.01-0.08 mg/kg/day . RESULTS Risperidone led to a significant greater reduction on CGI scale . There was significant improvement on RF-RLRS sensory motor and language subscale and ABC scores in risperidone group . Weight gain was observed more frequently in the haloperidol group at week 24 . CONCLUSIONS These results demonstrate that risperidone is more efficacious and well tolerated than haloperidol in the long-term maintenance treatment of autistic disorder .
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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_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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Outcome_Other
long-term efficacy and safety
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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
Clinical Global Impression Scale [ CGI-I ]
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Outcome_Mental
Ritvo-Freeman Real Life Rating Scale [ RF-RLRS ]
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Outcome_Mental
Aberrant Behavior Checklist [ ABC ]
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Outcome_Mental
Turgay DSM-IV Pervasive Developmental Disorder Rating Scale
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Outcome_Other
reduction
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Outcome_Mental
CGI scale
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Outcome_Mental
RF-RLRS sensory motor and language subscale
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Outcome_Mental
ABC scores
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Outcome_Physical
Weight gain
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Participant_Age
children
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Participant_Age
adolescents
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Participant_Condition
autistic disorder
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Participant_Condition
autistic disorder
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Participant_Condition
autistic
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Participant_Age
children
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Participant_Age
adolescents
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Participant_Sample-size
28 subjects
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Participant_Age
8 and 18 ages
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Participant_Condition
autistic disorder