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document
A pilot double-blind placebo-controlled trial of pioglitazone as adjunctive treatment to risperidone : Effects on aberrant behavior in children with autism . To assess the safety and efficacy of pioglitazone added to risperidone in the treatment of irritability in autistic disorder ( AD ) , we conducted this study . In a 10-week , randomized , double-blind , parallel-group , placebo-controlled clinical trial , 44 outpatients of both genders aged 4-12 years with a diagnosis of AD and a score of ≥12 on the Aberrant Behavior Checklist-Community ( ABC-C ) irritability subscale were included . Mean change of ABC-C irritability subscale score as primary outcome , change in other ABC-C subscale scores and partial and complete responses were compared between two groups . Twenty patients completed the trial in each group . Level of reduction and effect of time×treatment interaction in the treatment group were significant for irritability ( P=0.03 ) , lethargy/social withdrawal ( P=0.04 ) and hyperactivity/non-compliance ( P=0.03 ) but not for stereotypic behavior and inappropriate speech subscales compared with the placebo group . Vomiting and headache were the most frequent reported side-effects . Results of this preliminary study indicate positive effects of pioglitazone compared with placebo in improving the behavioral symptoms of AD .
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
pioglitazone
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Intervention_Pharmacological
pioglitazone added to risperidone
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Intervention_Control
placebo-controlled
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Outcome_Other
safety and efficacy
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Outcome_Other
Mean change of ABC-C irritability subscale score
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Outcome_Other
for irritability ( P=0.03 ) , lethargy/social withdrawal
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Outcome_Other
and hyperactivity/non-compliance
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Outcome_Adverse-effects
Vomiting and headache
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Outcome_Mental
the behavioral symptoms of
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Participant_Age
children
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Participant_Condition
autism
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Participant_Condition
autistic disorder ( AD )
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Participant_Sample-size
44
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Participant_Sex
both genders
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Participant_Age
4-12 years
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Participant_Condition
AD
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Participant_Sample-size
Twenty patients