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

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 MasiJörg M Fegert, Stefano Vicari, Sara Carucci, Ralf W Dittmann, Jan K Buitelaar, The PERS Consortium

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    14 Citations (Scopus)

    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.
    Original languageEnglish
    JournalEuropean Child & Adolescent Psychiatry
    DOIs
    Publication statusPublished - 2013

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    Risperidone
    Conduct Disorder
    Pediatrics
    Intelligence
    Pharmacovigilance
    Standard of Care
    Antipsychotic Agents
    Maintenance
    Drug Therapy
    Pharmaceutical Preparations

    Cite this

    Glennon, Jeffrey ; Purper-Ouakil, Diane ; Bakker, Mireille ; Zuddas, Alessandro ; Hoekstra, Pieter ; Schulze, Ulrike ; Castro-Fornieles, Josefina ; Santosh, Paramala J ; Arango, Celso ; Kölch, Michael ; Coghill, David ; Flamarique, Itziar ; Penzol, Maria J ; Wan, Mandy ; Murray, Macey ; Wong, Ian C K ; Danckaerts, Marina ; Bonnot, Olivier ; Falissard, Bruno ; Masi, Gabriele ; Fegert, Jörg M ; Vicari, Stefano ; Carucci, Sara ; Dittmann, Ralf W ; Buitelaar, Jan K ; The PERS Consortium. / Paediatric European Risperidone Studies (PERS) : context, rationale, objectives, strategy, and challenges. In: European Child & Adolescent Psychiatry. 2013.
    @article{e4f65fcbb52f49eb84b2593d1cf17e33,
    title = "Paediatric European Risperidone Studies (PERS): context, rationale, objectives, strategy, and challenges",
    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.",
    author = "Jeffrey Glennon and Diane Purper-Ouakil and Mireille Bakker and Alessandro Zuddas and Pieter Hoekstra and Ulrike Schulze and Josefina Castro-Fornieles and Santosh, {Paramala J} and Celso Arango and Michael K{\"o}lch and David Coghill and Itziar Flamarique and Penzol, {Maria J} and Mandy Wan and Macey Murray and Wong, {Ian C K} and Marina Danckaerts and Olivier Bonnot and Bruno Falissard and Gabriele Masi and Fegert, {J{\"o}rg M} and Stefano Vicari and Sara Carucci and Dittmann, {Ralf W} and Buitelaar, {Jan K} and {The PERS Consortium}",
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    doi = "10.1007/s00787-013-0498-3",
    language = "English",
    journal = "European Child & Adolescent Psychiatry",
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    publisher = "Springer Verlag",

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    Glennon, J, Purper-Ouakil, D, Bakker, M, Zuddas, A, Hoekstra, P, Schulze, U, Castro-Fornieles, J, Santosh, PJ, Arango, C, Kölch, M, Coghill, D, Flamarique, I, Penzol, MJ, Wan, M, Murray, M, Wong, ICK, Danckaerts, M, Bonnot, O, Falissard, B, Masi, G, Fegert, JM, Vicari, S, Carucci, S, Dittmann, RW, Buitelaar, JK & The PERS Consortium 2013, 'Paediatric European Risperidone Studies (PERS): context, rationale, objectives, strategy, and challenges', European Child & Adolescent Psychiatry. https://doi.org/10.1007/s00787-013-0498-3

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

    In: European Child & Adolescent Psychiatry, 2013.

    Research output: Contribution to journalArticle

    TY - JOUR

    T1 - Paediatric European Risperidone Studies (PERS)

    T2 - context, rationale, objectives, strategy, and challenges

    AU - Glennon, Jeffrey

    AU - Purper-Ouakil, Diane

    AU - Bakker, Mireille

    AU - Zuddas, Alessandro

    AU - Hoekstra, Pieter

    AU - Schulze, Ulrike

    AU - Castro-Fornieles, Josefina

    AU - Santosh, Paramala J

    AU - Arango, Celso

    AU - Kölch, Michael

    AU - Coghill, David

    AU - Flamarique, Itziar

    AU - Penzol, Maria J

    AU - Wan, Mandy

    AU - Murray, Macey

    AU - Wong, Ian C K

    AU - Danckaerts, Marina

    AU - Bonnot, Olivier

    AU - Falissard, Bruno

    AU - Masi, Gabriele

    AU - Fegert, Jörg M

    AU - Vicari, Stefano

    AU - Carucci, Sara

    AU - Dittmann, Ralf W

    AU - Buitelaar, Jan K

    AU - The PERS Consortium

    PY - 2013

    Y1 - 2013

    N2 - 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.

    AB - 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.

    U2 - 10.1007/s00787-013-0498-3

    DO - 10.1007/s00787-013-0498-3

    M3 - Article

    C2 - 24337449

    JO - European Child & Adolescent Psychiatry

    JF - European Child & Adolescent Psychiatry

    SN - 1018-8827

    ER -