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document
A double-blind , placebo-controlled study of the efficacy of transdermal clonidine in autism . BACKGROUND Autistic individuals often exhibit hyperarousal behaviors ( e.g. , stereotyped body movements , self-stimulation , hypervigilance , and hyperactivity ) . Clonidine , an alpha 2-adrenergic receptor agonist , has been shown to be effective in reducing impulsivity , inattention , and hyperactivity associated with attention deficit disorder with hyperactivity . This study investigated the efficacy and safety of transdermal clonidine in reducing hyperarousal behaviors associated with autism . METHOD A double-blind , placebo-crossover study with transdermal clonidine was performed in nine autistic males ( aged 5 to 33 years ) . Subjects received either clonidine ( approximately 0.005 mg/kg/day ) or placebo by a weekly transdermal patch . Each trial lasted 4 weeks with a 2-week washout period between treatment phases . Subjects were evaluated every 2 weeks by clinician raters and weekly by parents . RESULTS The clonidine treatment showed a significant difference from placebo treatment on three subscales of the Ritvo-Freeman Real Life Rating Scale ( i.e. , social relationship to people , affectual responses , and sensory responses ) . The Clinical Global Impressions scale indicated that clonidine produced a significant improvement on severity of illness , global improvement , and efficacy index for therapeutic effect of the drug . A patient global rating scale showed clonidine treatment resulted in significant improvement in comparison with placebo . Adverse effects included sedation and fatigue during the first 2 weeks of clonidine treatment . CONCLUSION Results from this preliminary study show that clonidine was effective in reducing several hyperarousal behaviors and improved social relationships in some autistic subjects . Further studies are needed in a larger autistic population to determine the dose-response relationship of clonidine .
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
transdermal clonidine
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Intervention_Pharmacological
Clonidine
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Intervention_Pharmacological
clonidine
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Intervention_Control
placebo-crossover
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Intervention_Pharmacological
clonidine
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Intervention_Pharmacological
clonidine
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Intervention_Control
placebo
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Intervention_Pharmacological
clonidine
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Intervention_Control
placebo
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Intervention_Pharmacological
clonidine
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Intervention_Pharmacological
clonidine
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Intervention_Control
placebo .
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Intervention_Pharmacological
clonidine
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Intervention_Pharmacological
clonidine
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Intervention_Pharmacological
clonidine .
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Outcome_Physical
efficacy and safety
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Outcome_Physical
Ritvo-Freeman Real Life Rating Scale ( i.e.
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Outcome_Mental
social relationship to people
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Outcome_Mental
affectual responses
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Outcome_Physical
Clinical Global Impressions scale
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Outcome_Physical
severity of illness
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Outcome_Other
global improvement
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Outcome_Other
efficacy index
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Outcome_Other
patient global rating scale
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Outcome_Adverse-effects
Adverse effects included sedation and fatigue
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Outcome_Mental
several hyperarousal behaviors
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Outcome_Mental
social relationships
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Participant_Condition
autism
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Participant_Condition
Autistic
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Participant_Condition
hyperarousal behaviors
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Participant_Condition
hyperarousal
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Participant_Condition
autism
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Participant_Sample-size
nine
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Participant_Condition
autistic
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Participant_Condition
autistic
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Participant_Condition
autistic