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document
A randomized double-blind study of atomoxetine versus placebo for attention-deficit/hyperactivity disorder symptoms in children with autism spectrum disorder . OBJECTIVE The efficacy of atomoxetine as treatment of symptoms of attention-deficit/hyperactivity disorder ( ADHD ) in patients with autism spectrum disorder ( ASD ) has not been established . METHOD In this study , 97 patients aged 6 to 17 years with ADHD and ASD were randomly assigned to double-blind treatment with 1.2 mg/kg/day atomoxetine or placebo for 8 weeks . The primary endpoint was the ADHD Rating Scale ( ADHD-RS ) score ; secondary endpoints were the Clinical Global Impression of ADHD-Improvement ( CGI-I ) and the Conners Teacher Rating Scale-Revised : Short Form ( CTRS-R : S ) score . RESULTS Baseline mean ADHD-RS scores for atomoxetine versus placebo were 40.7 and 38.6 ; after 8 weeks , mixed-effect model repeated-measure means were 31.6 ( 95 % confidence interval 29.2-33.9 ) and 38.3 ( 36.0-40.6 ) , respectively , with a difference in least square means of -6.7 ( -10.0 to -3.4 ; p < .001 ) . The CTRS-R : S Hyperactivity subscore also improved significantly for atomoxetine compared with placebo , but not the other CTRS-R : S subscores . However , there were not significantly more patients on atomoxetine ( 20.9 % ) who improved much , or very much according to the CGI-I , than on placebo ( 8.7 % ; p = 0.14 ) . Adverse events ( mostly nausea , decrease in appetite , fatigue , and early morning awakening ) were reported in 81.3 % of atomoxetine patients and 65.3 % of placebo patients ( p > .1 ) . There were no serious adverse events . CONCLUSIONS Atomoxetine moderately improved ADHD symptoms in patients with ASD and was generally well tolerated . Adverse events in this study were similar to those in other studies with ADHD patients without ASD . Clinical trial registration information-A Randomized Double-Blind Study of Atomoxetine Versus Placebo for ADHD Symptoms in Children with ASD ; www.clinicaltrials.gov ; NCT00380692 .
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Intervention_Pharmacological
atomoxetine
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Intervention_Control
placebo
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Intervention_Pharmacological
atomoxetine
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Intervention_Pharmacological
atomoxetine
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Intervention_Control
placebo
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Intervention_Pharmacological
atomoxetine
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Intervention_Control
placebo
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Intervention_Pharmacological
atomoxetine
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Intervention_Control
placebo
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Intervention_Pharmacological
atomoxetine
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Intervention_Control
placebo
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Intervention_Pharmacological
atomoxetine
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Intervention_Pharmacological
Atomoxetine
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Intervention_Pharmacological
Atomoxetine
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Outcome_Mental
ADHD Rating Scale ( ADHD-RS ) score
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Outcome_Mental
Clinical Global Impression of ADHD-Improvement ( CGI-I )
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Outcome_Mental
Conners Teacher Rating Scale-Revised : Short Form ( CTRS-R : S ) score
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Outcome_Mental
ADHD-RS
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Outcome_Mental
CTRS-R : S
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Outcome_Mental
CTRS-R : S
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Outcome_Adverse-effects
nausea
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Outcome_Adverse-effects
appetite , fatigue , and early morning awakening
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Outcome_Adverse-effects
adverse events