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document
Long-term treatment with atomoxetine for attention-deficit/hyperactivity disorder symptoms in children and adolescents with autism spectrum disorder : an open-label extension study . OBJECTIVE The efficacy and tolerability of long-term treatment with atomoxetine for symptoms of attention-deficit/hyperactivity disorder ( ADHD ) in children with autism spectrum disorder ( ASD ) has not been established . METHODS In this study , 88 patients 6-17 years of age , with ADHD and ASD , were treated with 1.2 mg/kg/day atomoxetine for 20 weeks as follow-up of an 8 week double-blind placebo-controlled period . Primary endpoint was the ADHD Rating Scale ( ADHD-RS ) . RESULTS After 8 weeks of initial treatment , the mean total , inattention , and hyperactivity-impulsivity ADHD-RS further decreased significantly from 34.9 to 27.0 for the total ADHD-RS , from 18.3 to 14.5 for the ADHD-RS inattention subscale , and from 16.5 to 12.6 for the hyperactivity-impulsivity subscale . Adverse events were mild and tended to diminish over time during continued treatment , especially regarding nausea and fatigue . There were no serious adverse events . CONCLUSIONS The results of the present analysis suggest that continued treatment with atomoxetine up to 28 weeks further improve ADHD symptoms in children and adolescents with ASD , while adverse events tend to subside . Future studies investigating the long-term efficacy of atomoxetine in children and adolescents with ASD should be randomized and placebo controlled . This study has been registered in ClinicalTrials.gov ( www.clinicaltrials.gov ) under registration number NCT00380692 .
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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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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
atomoxetine
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Intervention_Pharmacological
atomoxetine
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Outcome_Mental
attention-deficit/hyperactivity disorder symptoms
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Outcome_Other
efficacy and tolerability
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Outcome_Mental
symptoms of attention-deficit/hyperactivity disorder ( ADHD )
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Outcome_Mental
ADHD Rating Scale ( ADHD-RS )
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Outcome_Mental
mean total , inattention
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Outcome_Mental
hyperactivity-impulsivity ADHD-RS
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Outcome_Mental
ADHD-RS inattention subscale
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Outcome_Mental
hyperactivity-impulsivity subscale
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Outcome_Adverse-effects
Adverse events
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Outcome_Adverse-effects
nausea and fatigue .
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Outcome_Adverse-effects
serious adverse events
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Outcome_Mental
improve ADHD symptoms
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Outcome_Adverse-effects
adverse events
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Participant_Condition
attention-deficit/hyperactivity disorder symptoms
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Participant_Age
children
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Participant_Age
adolescents
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Participant_Condition
autism spectrum disorder
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Participant_Age
children
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Participant_Condition
autism spectrum disorder ( ASD )
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Participant_Sample-size
88 patients
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Participant_Age
6-17 years of age
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Participant_Condition
ADHD
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Participant_Condition
ASD
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Participant_Age
children
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Participant_Age
adolescents
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Participant_Condition
ASD
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Participant_Age
children
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Participant_Age
adolescents
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Participant_Condition
ASD