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Open Access 01-12-2014 | Original Contribution

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

Authors: Jeffrey Glennon, Diane Purper-Ouakil, Mireille Bakker, Alessandro Zuddas, Pieter Hoekstra, Ulrike Schulze, Josefina Castro-Fornieles, Paramala J. Santosh, Celso Arango, Michael Kölch, David Coghill, Itziar Flamarique, Maria J. Penzol, Mandy Wan, Macey Murray, Ian C. K. Wong, Marina Danckaerts, Olivier Bonnot, Bruno Falissard, Gabriele Masi, Jörg M. Fegert, Stefano Vicari, Sara Carucci, Ralf W. Dittmann, Jan K. Buitelaar, The PERS Consortium

Published in: European Child & Adolescent Psychiatry | Issue 12/2014

Abstract

In children and adolescents with conduct disorder (CD), pharmacotherapy is considered when non-pharmacological interventions do not improve symptoms and functional impairment. Risperidone, a second-generation antipsychotic is increasingly prescribed off-label in this indication, but its efficacy and tolerability is poorly studied in CD, especially in young people with normal intelligence. The Paediatric European Risperidone Studies (PERS) include a series of trials to assess short-term efficacy, tolerability and maintenance effects of risperidone in children and adolescents with CD and normal intelligence as well as long-term tolerability in a 2-year pharmacovigilance. In addition to its core studies, secondary PERS analyses will examine moderators of drug effects. As PERS is a large-scale academic project involving a collaborative network of expert centres from different countries, it is expected that results will lead to strengthen the evidence base for the use of risperidone in CD and improve standards of care. Challenging issues faced by the PERS consortium are described to facilitate future developments in paediatric neuropsychopharmacology.

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Title: Paediatric European Risperidone Studies (PERS): context, rationale, objectives, strategy, and challenges
Authors: Jeffrey Glennon
Diane Purper-Ouakil
Mireille Bakker
Alessandro Zuddas
Pieter Hoekstra
Ulrike Schulze
Josefina Castro-Fornieles
Paramala J. Santosh
Celso Arango
Michael Kölch
David Coghill
Itziar Flamarique
Maria J. Penzol
Mandy Wan
Macey Murray
Ian C. K. Wong
Marina Danckaerts
Olivier Bonnot
Bruno Falissard
Gabriele Masi
Jörg M. Fegert
Stefano Vicari
Sara Carucci
Ralf W. Dittmann
Jan K. Buitelaar
The PERS Consortium
Publication date: 01-12-2014
Publisher: Springer Berlin Heidelberg
Published in: European Child & Adolescent Psychiatry / Issue 12/2014
Print ISSN: 1018-8827
Electronic ISSN: 1435-165X
DOI: https://doi.org/10.1007/s00787-013-0498-3

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

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