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document
Methodological issues in designing a multisite trial of risperidone in children and adolescents with autism . OBJECTIVE To describe the methodological challenges and decisions made in developing a multisite , controlled study of risperidone in children and adolescents with autism . METHODS Review the design considerations for clinical trials in children with autistic disorder accompanied by severe tantrums , aggressive and/or self-injurious behaviors . These design considerations include the definition of inclusion criteria that are relevant to clinical practice and matching study design to the goal of evaluating short- and long-term effects . Additional ethical and scientific issues concern the length of trial and sample size . RESULTS We undertook a short-term , placebo-controlled study to evaluate the efficacy and safety of risperidone in children and adolescents with autistic disorder . This trial design was followed by an extended open-label maintenance on risperidone to confirm durability of treatment effects and to monitor safety . Finally , a placebo-controlled discontinuation study tested the need for continuous treatment . CONCLUSIONS In the absence of standard pharmacological treatment for children with autistic disorder , a placebo-controlled study remains the most appropriate method of testing efficacy and safety . The clinical relevance of this study is enhanced by the addition of an extended maintenance phase followed by a placebo discontinuation .
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Intervention_Pharmacological
risperidone
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Intervention_Pharmacological
risperidone
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Intervention_Control
placebo-controlled
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Intervention_Pharmacological
risperidone
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Intervention_Pharmacological
risperidone
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Intervention_Control
placebo
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Outcome_Other
efficacy
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Outcome_Other
safety
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Outcome_Other
durability
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Outcome_Other
safety
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Participant_Condition
children and adolescents with autism .