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document
Aripiprazole in the treatment of irritability in children and adolescents with autistic disorder . OBJECTIVE The objective of this study was to evaluate short-term efficacy and safety of aripiprazole in the treatment of irritability in children and adolescents with autistic disorder who were manifesting behaviors such as tantrums , aggression , self-injurious behavior , or a combination of these . METHODS This 8-week , double-blind , randomized , placebo-controlled , parallel-group study was conducted of children and adolescents ( aged 6-17 years ) with autistic disorder . Patients were randomly assigned ( 1:1 ) to flexibly dosed aripiprazole ( target dosage : 5 , 10 , or 15 mg/day ) or placebo . Efficacy outcome measures included the Aberrant Behavior Checklist irritability subscale and the Clinical Global Impression-Improvement score ( CGI-I ) . Safety and tolerability were also assessed . RESULTS Ninety-eight patients were randomly assigned to receive placebo ( n = 51 ) or aripiprazole ( n = 47 ) . Mean improvement in Aberrant Behavior Checklist irritability subscale score was significantly greater with aripiprazole than with placebo from week 1 through week 8 . Aripiprazole demonstrated significantly greater global improvements than placebo , as assessed by the mean CGI-I score from week 1 through week 8 ; however , clinically significant residual symptoms may still persist for some patients . Discontinuation rates as a result of adverse events ( AEs ) were 10.6 % for aripiprazole and 5.9 % for placebo . Extrapyramidal symptom-related AE rates were 14.9 % for aripiprazole and 8.0 % for placebo . No serious AEs were reported . Mean weight gain was 2.0 kg on aripiprazole and 0.8 kg on placebo at week 8 . CONCLUSIONS Aripiprazole was efficacious in children and adolescents with irritability associated with autistic disorder and was generally safe and well tolerated .
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Intervention_Pharmacological
Aripiprazole
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Intervention_Pharmacological
aripiprazole
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Intervention_Pharmacological
flexibly dosed aripiprazole
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Intervention_Control
placebo
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Intervention_Control
placebo
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Intervention_Pharmacological
aripiprazole
43013
Intervention_Control
placebo
43014
Intervention_Pharmacological
aripiprazole
43015
Intervention_Control
placebo
43016
Intervention_Pharmacological
aripiprazole
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Intervention_Control
placebo
43018
Intervention_Pharmacological
Aripiprazole
43019
Outcome_Mental
irritability
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Outcome_Other
short-term efficacy and safety
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Outcome_Mental
irritability
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Outcome_Mental
Aberrant Behavior Checklist irritability subscale and the Clinical Global Impression-Improvement score ( CGI-I ) .
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Outcome_Other
Safety and tolerability
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Outcome_Mental
Aberrant Behavior Checklist irritability subscale score
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Outcome_Mental
CGI-I score
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Outcome_Physical
residual symptoms
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Outcome_Adverse-effects
Extrapyramidal symptom-related AE rates
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Outcome_Physical
weight gain
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Participant_Age
children and adolescents
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Participant_Condition
autistic disorder
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Participant_Age
children and adolescents
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Participant_Condition
autistic disorder
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Participant_Condition
tantrums , aggression , self-injurious behavior , or a combination of these
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Participant_Age
children
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Participant_Age
adolescents ( aged 6-17 years )
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Participant_Sample-size
Ninety-eight patients
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Participant_Age
children
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Participant_Age
adolescents