24478
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Randomized , controlled , crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity . CONTEXT Hyperactivity and inattention are common symptoms in children with autistic disorder and related pervasive developmental disorders , but studies of stimulants in these conditions have been inconclusive . OBJECTIVES To determine the efficacy and safety of methylphenidate hydrochloride in children with pervasive developmental disorders and hyperactivity . DESIGN Double-blind , placebo-controlled , crossover trial followed by open-label continuation . SETTING Five academic outpatient clinics . PARTICIPANTS Seventy-two drug-free children , aged 5 to 14 years , with pervasive developmental disorders accompanied by moderate to severe hyperactivity . INTERVENTIONS Prior to randomization , subjects entered a 1-week test-dose phase in which each subject received placebo for 1 day followed by increasing doses of methylphenidate ( low , medium , and high doses ) that were each given for 2 days . The low , medium , and high doses of methylphenidate hydrochloride were based on weight , and they ranged from 7.5 mg/d to 50.0 mg/d in divided doses . Subjects who tolerated the test dose ( n = 66 ) were assigned to receive placebo for 1 week and then 3 methylphenidate doses in random order during a double-blind , crossover phase . Children responding to methylphenidate then entered 8 weeks of open-label treatment at the individually determined best dose . MAIN OUTCOME MEASURES The primary outcome measure was the teacher-rated hyperactivity subscale of the Aberrant Behavior Checklist . Response was defined as " much improved " or " very much improved " on the Clinical Global Impressions Improvement item coupled with considerable reductions in the parent-rated and/or teacher-rated Aberrant Behavior Checklist hyperactivity subscale score . RESULTS Methylphenidate was superior to placebo on the primary outcome measure , with effect sizes ranging from 0.20 to 0.54 depending on dose and rater . Thirty-five ( 49 % ) of 72 enrolled subjects were classified as methylphenidate responders . Adverse effects led to the discontinuation of study medication in 13 ( 18 % ) of 72 subjects . CONCLUSIONS Methylphenidate was often efficacious in treating hyperactivity associated with pervasive developmental disorders , but the magnitude of response was less than that seen in typically developing children with attention-deficit/hyperactivity disorder . Adverse effects were more frequent .
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Intervention_Pharmacological
methylphenidate
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Intervention_Pharmacological
methylphenidate hydrochloride
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Intervention_Control
placebo
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Intervention_Pharmacological
doses of methylphenidate
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Intervention_Pharmacological
methylphenidate hydrochloride
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Intervention_Control
placebo
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Intervention_Pharmacological
methylphenidate
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Intervention_Pharmacological
methylphenidate
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Intervention_Pharmacological
Methylphenidate
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Intervention_Control
placebo
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Intervention_Pharmacological
methylphenidate
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Intervention_Pharmacological
Methylphenidate
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Outcome_Mental
teacher-rated hyperactivity subscale of the Aberrant Behavior Checklist
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Outcome_Other
much improved
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Outcome_Other
very much improved
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Outcome_Mental
Clinical Global Impressions Improvement item
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Outcome_Mental
parent-rated and/or teacher-rated Aberrant Behavior Checklist hyperactivity subscale score
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Outcome_Other
effect sizes
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Outcome_Adverse-effects
Adverse effects
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Participant_Condition
hydrochloride in children
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Participant_Condition
13 ( 18 % ) of 72 subjects .