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Paediatric European Risperidone Studies (PERS): context, rationale, objectives, strategy, and challenges.

Jeffrey Glennon1, Diane Purper-Ouakil, Mireille Bakker

  • 1Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behavior, RUNMC Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands, J.Glennon@donders.ru.nl.

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Risperidone, an antipsychotic, is being studied for treating conduct disorder (CD) in children and adolescents. The Paediatric European Risperidone Studies (PERS) aim to improve evidence for its use and care standards.

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Area of Science:

  • Child and Adolescent Psychiatry
  • Neuropsychopharmacology
  • Pediatric Clinical Trials

Background:

  • Pharmacotherapy is considered for conduct disorder (CD) in youth when non-pharmacological methods fail.
  • Risperidone, a second-generation antipsychotic, is increasingly used off-label for CD, but its efficacy and tolerability in this population, especially in those with normal intelligence, are not well-established.

Purpose of the Study:

  • To assess the short-term efficacy, tolerability, and maintenance effects of risperidone in children and adolescents with CD and normal intelligence.
  • To evaluate the long-term tolerability of risperidone through a 2-year pharmacovigilance study.
  • To examine moderators of drug effects through secondary analyses within the PERS project.

Main Methods:

  • The Paediatric European Risperidone Studies (PERS) is a large-scale academic project involving a network of expert centers across multiple countries.
  • The project includes a series of trials to evaluate risperidone's effects.
  • Secondary analyses will investigate factors influencing treatment outcomes.

Main Results:

  • (Results are pending publication as PERS is ongoing) The study aims to provide robust data on risperidone's effectiveness and safety.
  • Anticipated outcomes include strengthening the evidence base for risperidone in pediatric CD.
  • The project seeks to improve clinical practice standards for managing CD in young people.

Conclusions:

  • The PERS project is expected to significantly contribute to understanding risperidone's role in treating pediatric conduct disorder.
  • Findings will inform clinical decision-making and enhance the standard of care for affected children and adolescents.
  • The consortium's experience aims to guide future research in pediatric neuropsychopharmacology.