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Aripiprazole treatment of irritability associated with autistic disorder and the relationship between prior antipsychotic exposure , adverse events , and weight change . OBJECTIVE The purpose of this study was to evaluate the impact of prior antipsychotic exposure ( PAE ) on safety and tolerability outcomes in pediatric subjects receiving aripiprazole treatment . METHODS This study was a post-hoc analysis of pooled data from two 8-week , double-blind , randomized , placebo-controlled studies evaluating aripiprazole for the treatment of irritability in pediatric subjects with autistic disorder , aged 6-17 years . Subjects were stratified by PAE ; adverse events ( AEs ) , and changes in weight , and metabolic measures were evaluated . For subjects receiving aripiprazole , regardless of PAE , baseline weight , age , gender , and symptom severity were evaluated in a regression model predicting body weight change . RESULTS Of 316 randomized subjects , 259 ( 82.0 % ) were antipsychotic naïve ( AN ) and 57 ( 18.0 % ) had a PAE . Aripiprazole-treated AN subjects were more likely than PAE subjects to report somnolence ( 11.9 % vs. 2.8 % ) , sedation ( 22.7 % vs. 11.1 % ) , or fatigue ( 17.0 % vs. 13.9 % ) . Rates of extrapyramidal disorder and drooling , but not akathisia or tremor , were marginally higher in AN subjects . Overall , 10.8 % of aripiprazole-treated AN subjects had at least one AE leading to discontinuation compared with 8.3 % of aripiprazole-treated PAE subjects . AN subjects receiving aripiprazole had a larger change in weight from baseline to endpoint compared with those receiving placebo ( 1.9 vs. 0.7 kg ; treatment difference 1.2 kg , 95 % CI : 0.5 , 1.9 ) than PAE subjects receiving aripiprazole compared with subjects receiving placebo ( 0.4 vs. -0.4 kg ; treatment difference 0.9 kg , 95 % CI : -0.6 , 2.4 ) . Regression analysis identified that younger subjects with higher baseline weight z-score were at highest risk for weight gain . There were no significant changes in metabolic measures compared with placebo in either group . CONCLUSIONS Weight gain was more pronounced in AN subjects and more likely to occur in younger subjects with a higher baseline weight z-score . AN subjects were more likely to experience AEs related to somnolence . However , based on discontinuations rates from AEs , overall tolerability was good for both AN and PAE groups . CLINICAL TRIAL REGISTRATION Study of aripiprazole in the treatment of children and adolescents with autistic disorder . Registry : www.clinicaltrials.gov . Identifiers : NCT00332241 and NCT00337571 .
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Intervention_Pharmacological
Aripiprazole
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
aripiprazole
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Outcome_Other
safety and tolerability outcomes
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Participant_Condition
autistic disorder
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Participant_Condition
pediatric subjects receiving aripiprazole treatment
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Participant_Condition
autistic disorder
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Participant_Age
aged 6-17 years .
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Participant_Sample-size
316 randomized subjects
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Participant_Sample-size
259 ( 82.0 %
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Participant_Sample-size
57 ( 18.0 % )
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Participant_Age
that younger subjects
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Participant_Age
younger subjects
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Participant_Age
children and adolescents
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Participant_Condition
autistic disorder