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document
Line-item analysis of the Aberrant Behavior Checklist : results from two studies of aripiprazole in the treatment of irritability associated with autistic disorder . OBJECTIVES The aim of this study was to evaluate the efficacy of aripiprazole in the treatment of discrete symptoms of irritability associated with autistic disorder , as well as other symptoms captured on the Aberrant Behavior Checklist ( ABC ) . METHODS This was a post hoc analysis of data from two 8-week , randomized , double-blind , multicenter trials to evaluate the efficacy of aripiprazole dosed flexibly ( 2-15 mg/day , n=47 ) or fixed ( 5 , 10 , or 15 mg/day , n = 166 ) versus placebo ( flexibly dosed , n = 51 ; fixed dose , n = 52 ) . The effects of treatment on the 58 ABC items were evaluated . RESULTS Statistically significantly greater improvement was seen with aripiprazole versus placebo ( p < 0.05 ) for all arms in both trials on the ABC-Irritability total subscale score and on the following individual ABC-Irritability items : Mood changes quickly , cries/screams inappropriately , and stamps feet/bangs objects . Several additional items measuring tantrum-like behaviors improved in the flexibly dosed trial and at least one arm of the fixed-dose trial ( p < 0.05 ) . Measures of self-injurious behavior , which had low baseline values , demonstrated numerical , but not statistically significant , improvement in both trials . Statistically significantly greater improvement in ABC Stereotypic Behavior and Hyperactivity total subscale scores was also consistent across all arms in both trials . In particular , there was a cluster of items related to hyperkinesis that were consistently sensitive to treatment . CONCLUSIONS Aripiprazole is efficacious in the treatment of irritability in children and adolescents with autistic disorder , particularly with respect to symptoms associated with tantrum behavior .
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Intervention_Pharmacological
aripiprazole
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Intervention_Pharmacological
aripiprazole
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Intervention_Pharmacological
aripiprazole dosed flexibly
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Intervention_Control
placebo
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Intervention_Pharmacological
aripiprazole
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Intervention_Control
placebo
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Intervention_Pharmacological
Aripiprazole
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Outcome_Mental
ABC-Irritability total subscale score and on the following individual ABC-Irritability items
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Outcome_Mental
Mood changes quickly
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Outcome_Mental
cries/screams inappropriately
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Outcome_Mental
stamps feet/bangs objects
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Outcome_Mental
tantrum-like behaviors
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Outcome_Mental
Measures of self-injurious behavior
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Outcome_Mental
ABC Stereotypic Behavior and Hyperactivity total subscale scores
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Outcome_Mental
hyperkinesis
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Participant_Condition
irritability
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Participant_Condition
autistic disorder
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Participant_Condition
autistic disorder