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

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

doi:10.1007/s00787-013-0498-3

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.Electronic supplementary materialThe online version of this article (doi:10.1007/s00787-013-0498-3) contains supplementary material, which is available to authorized users.

Highlights

The prescription of psychotropic medication is becoming an increasingly important component of comprehensive treatment programmes of child and adolescent psychiatric disorders
conduct disorder (CD) is a matter of significant public health and societal concern because of strong associations with adverse scholastic and work performance, disrupted peer and family relationships, excessive risk-taking behaviours which often result in personal injury, loss of property, alcohol, nicotine and substance abuse, accident proneness and development of later antisocial personality disorder [14, 15]
The pharmacovigilance study within Paediatric European Risperidone Studies (PERS) is aimed at filling in the safety knowledge gap, through conducting an observational open-label study in which 600 children and adolescents aged between 5 and 16 years who have been prescribed risperidone will be followed over a treatment period of up to 2 years and comparing them to 250 controls

Summary

Introduction

The prescription of psychotropic medication is becoming an increasingly important component of comprehensive treatment programmes of child and adolescent psychiatric disorders. This increased prevalence was mainly attributable to both increased use of SGAs and a longer duration of use, which clearly increases the exposure of this young population to incompletely understood risks [8, 9] These increased prescription rates of risperidone and other SGAs for children and adolescents, for non-psychotic conditions, the off-license status of many of these prescriptions, their metabolic side effects and the inadequacy of long-term surveillance have raised concern about uncritical prescriptions [2, 10, 11]. We describe the rationale of the PERS studies, which include non-commercial clinical trials and

Flamarique e-mail

Aims and objectives of PERS

Ethical considerations

Findings

Discussion