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document
Double-blind , placebo-controlled study of amantadine hydrochloride in the treatment of children with autistic disorder . OBJECTIVE To test the hypothesis that amantadine hydrochloride is a safe and effective treatment for behavioral disturbances -- for example , hyperactivity and irritability -- in children with autism . METHOD Thirty-nine subjects ( intent to treat ; 5-19 years old ; IQ > 35 ) had autism diagnosed according to DSM-IV and ICD-10 criteria using the Autism Diagnostic Interview-Revised and the Autism Diagnostic Observation Schedule-Generic . The Aberrant Behavior Checklist-Community Version ( ABC-CV ) and Clinical Global Impressions ( CGI ) scale were used as outcome variables . After a 1-week , single-blind placebo run-in , patients received a single daily dose of amantadine ( 2.5 mg/kg per day ) or placebo for the next week , and then bid dosing ( 5.0 mg/kg per day ) for the subsequent 3 weeks . RESULTS When assessed on the basis of parent-rated ABC-CV ratings of irritability and hyperactivity , the mean placebo response rate was 37 % versus amantadine at 47 % ( not significant ) . However , in the amantadine-treated group there were statistically significant improvements in absolute changes in clinician-rated ABC-CVs for hyperactivity ( amantadine -6.4 versus placebo -2.1 ; p = .046 ) and inappropriate speech ( -1.9 versus 0.4 ; p = .008 ) . CGI scale ratings were higher in the amantadine group : 53 % improved versus 25 % ( p = .076 ) . Amantadine was well tolerated . CONCLUSIONS Parents did not report statistically significant behavioral change with amantadine . However , clinician-rated improvements in behavioral ratings following treatment with amantadine suggest that further studies with this or other drugs acting on the glutamatergic system are warranted . The design of these and similar drug trials in children with autistic disorder must take into account the possibility of a large placebo response .
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
amantadine hydrochloride
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Intervention_Pharmacological
amantadine
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Intervention_Pharmacological
amantadine
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Intervention_Control
placebo
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Intervention_Pharmacological
amantadine-treated
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Intervention_Pharmacological
Amantadine
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Intervention_Pharmacological
amantadine
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Outcome_Mental
behavioral disturbances
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Outcome_Mental
hyperactivity and irritability
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Outcome_Mental
Aberrant Behavior Checklist-Community Version ( ABC-CV ) and Clinical Global Impressions ( CGI )
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Outcome_Mental
irritability
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Outcome_Mental
hyperactivity
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Outcome_Mental
hyperactivity
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Outcome_Mental
inappropriate speech
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Outcome_Mental
CGI scale ratings
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Outcome_Mental
behavioral change
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Outcome_Mental
behavioral ratings
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Participant_Condition
autistic disorder
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Participant_Condition
autism
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Participant_Sample-size
Thirty-nine subjects
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Participant_Condition
autism diagnosed according to DSM-IV and ICD-10 criteria using the Autism Diagnostic Interview-Revised and the Autism Diagnostic Observation Schedule-Generic
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Participant_Condition
autistic disorder