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Atomoxetine for hyperactivity in autism spectrum disorders : placebo-controlled crossover pilot trial . OBJECTIVE To explore placebo-controlled efficacy and safety of atomoxetine ( ATX ) for attention-deficit/hyperactivity disorder ( ADHD ) symptoms in children with autism spectrum disorders ( ASD ) . METHOD Children ages 5 to 15 with ASD and prominent ADHD symptoms were randomly assigned to order in a crossover of clinically titrated ATX and placebo , 6 weeks each , separated by 1-week washout . Slopes for each condition were compared by paired t test . RESULTS In 2004-2005 , 12 boys and 4 girls ( 7 with autistic disorder , 1 Asperger 's , 8 pervasive developmental disorder not otherwise specified ) all completed at least 3 weeks of each condition . On the primary outcome , the Hyperactivity subscale of the Aberrant Behavior Checklist , ATX was superior to placebo ( p =.043 , effect size d = 0.90 ) . It was also superior on a 0 to 3 rating of nine DSM-IV ADHD hyperactive/impulsive symptoms ( p =.005 , d = 1.27 ) , but missed significance on nine inattentive symptoms ( p =.053 , d= 0.89 ) . Nine subjects responded to ATX , four to placebo ( 25 % improvement on the Hyperactivity subscale plus Clinical Global Impressions-Improvement of 1-2 . One was rehospitalized for recurrent violence on ATX . Adverse events were otherwise tolerable , with no tendency to stereotypy . CONCLUSIONS ATX appears safe and effective for treating hyperactivity in some children with autism spectrum disorders . The effect appears as large as in a multisite methylphenidate trial in the same population , with fewer intolerable side effects . Further study in autism spectrum disorders is indicated .
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Intervention_Pharmacological
Atomoxetine
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Intervention_Pharmacological
atomoxetine ( ATX )
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Intervention_Pharmacological
ATX
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Intervention_Control
placebo
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Intervention_Pharmacological
methylphenidate
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Outcome_Mental
Hyperactivity subscale of the Aberrant Behavior Checklist , ATX
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Outcome_Physical
DSM-IV ADHD hyperactive/impulsive symptoms
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Outcome_Physical
Hyperactivity subscale plus Clinical Global Impressions-Improvement
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Outcome_Other
rehospitalized
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Outcome_Adverse-effects
Adverse events
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Participant_Condition
hyperactivity in autism spectrum disorders
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Participant_Condition
attention-deficit/hyperactivity disorder ( ADHD ) symptoms
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Participant_Condition
autism spectrum disorders ( ASD )
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Participant_Age
Children ages 5 to 15
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Participant_Sample-size
12
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Participant_Sex
boys
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Participant_Sample-size
4
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Participant_Sex
girls
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Participant_Age
children