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

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          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 material

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

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          Most cited references57

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          Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data.

          To describe the psychometric properties of the Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime version (K-SADS-PL) interview, which surveys additional disorders not assessed in prior K-SADS, contains improved probes and anchor points, includes diagnosis-specific impairment ratings, generates DSM-III-R and DSM-IV diagnoses, and divides symptoms surveyed into a screening interview and five diagnostic supplements. Subjects were 55 psychiatric outpatients and 11 normal controls (aged 7 through 17 years). Both parents and children were used as informants. Concurrent validity of the screen criteria and the K-SADS-PL diagnoses was assessed against standard self-report scales. Interrater (n = 15) and test-retest (n = 20) reliability data were also collected (mean retest interval: 18 days; range: 2 to 36 days). Rating scale data support the concurrent validity of screens and K-SADS-PL diagnoses. Interrater agreement in scoring screens and diagnoses was high (range: 93% to 100%). Test-retest reliability kappa coefficients were in the excellent range for present and/or lifetime diagnoses of major depression, any bipolar, generalized anxiety, conduct, and oppositional defiant disorder (.77 to 1.00) and in the good range for present diagnoses of posttraumatic stress disorder and attention-deficit hyperactivity disorder (.63 to .67). Results suggest the K-SADS-PL generates reliable and valid child psychiatric diagnoses.
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            The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults.

            Research on suicide prevention and interventions requires a standard method for assessing both suicidal ideation and behavior to identify those at risk and to track treatment response. The Columbia-Suicide Severity Rating Scale (C-SSRS) was designed to quantify the severity of suicidal ideation and behavior. The authors examined the psychometric properties of the scale. The C-SSRS's validity relative to other measures of suicidal ideation and behavior and the internal consistency of its intensity of ideation subscale were analyzed in three multisite studies: a treatment study of adolescent suicide attempters (N=124); a medication efficacy trial with depressed adolescents (N=312); and a study of adults presenting to an emergency department for psychiatric reasons (N=237). The C-SSRS demonstrated good convergent and divergent validity with other multi-informant suicidal ideation and behavior scales and had high sensitivity and specificity for suicidal behavior classifications compared with another behavior scale and an independent suicide evaluation board. Both the ideation and behavior subscales were sensitive to change over time. The intensity of ideation subscale demonstrated moderate to strong internal consistency. In the adolescent suicide attempters study, worst-point lifetime suicidal ideation on the C-SSRS predicted suicide attempts during the study, whereas the Scale for Suicide Ideation did not. Participants with the two highest levels of ideation severity (intent or intent with plan) at baseline had higher odds for attempting suicide during the study. These findings suggest that the C-SSRS is suitable for assessment of suicidal ideation and behavior in clinical and research settings.
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              A children's global assessment scale (CGAS).

              We evaluated the Children's Global Assessment Scale (CGAS), an adaptation of the Global Assessment Scale for adults. Our findings indicate that the CGAS can be a useful measure of overall severity of disturbance. It was found to be reliable between raters and across time. Moreover, it demonstrated both discriminant and concurrent validity. Given these favorable psychometric properties and its relative simplicity, the CGAS is recommended to both clinicians and researchers as a complement to syndrome-specific scales.
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                Author and article information

                Contributors
                J.Glennon@donders.ru.nl
                +33-4-67336009 , +33-4-67337245 , d-purper_ouakil@chu-montpellier.fr
                m.bakker@cns.umcn.nl
                azuddas@unica.it
                p.hoekstra@accare.nl
                Ulrike.Schulze@uniklinik-ulm.de
                JCASTRO@clinic.ub.es
                paramala.1.santosh@kcl.ac.uk
                carango@hggm.es
                michael.koelch@uniklinik-ulm.de
                david.coghill@btinternet.com
                IFLAMARI@clinic.ub.es
                mjpenzol@iisgm.com
                Mandy.Wan@gstt.nhs.uk
                macey.murray@ucl.ac.uk
                wongick@hku.hk
                marina.danckaerts@uzleuven.be
                olivier.bonnot@psl.aphp.fr
                bruno.falissard@gmail.com
                gabriele.masi@inpe.unipi.it
                Joerg.Fegert@uniklinik-ulm.de
                stefano.vicari@opbg.net
                sara.carucci@gmail.com
                ralf.dittmann@zi-mannheim.de
                J.Buitelaar@psy.umcn.nl
                Journal
                Eur Child Adolesc Psychiatry
                Eur Child Adolesc Psychiatry
                European Child & Adolescent Psychiatry
                Springer Berlin Heidelberg (Berlin/Heidelberg )
                1018-8827
                1435-165X
                15 December 2013
                15 December 2013
                2014
                : 23
                : 12
                : 1149-1160
                Affiliations
                [ ]Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behavior, RUNMC Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands
                [ ]Médecine Psychologique de l’Enfant et de l’Adolescent, CHRU Montpellier-Hôpital Saint Eloi, 80 Avenue Augustin Fliche, 34295 Montpellier Cedex 5, France
                [ ]INSERM Team 1, INSERM U894-Team 1, Center of Psychiatry and Neurosciences, Paris, France
                [ ]Department of Biomedical Sciences, Cagliari University Hospital, University of Cagliari, Cagliari, Italy
                [ ]Department of Psychiatry, University Medical Center Groningen, Groningen, The Netherlands
                [ ]Centre for Interventional Paediatric Psychopharmacology, South London and Maudsley NHS Foundation Trust, London, UK
                [ ]Department of Child Psychiatry, King’s College London, London, UK
                [ ]Child and Adolescent Psychiatry Department, Facultad de Medicina, Hospital General Universitario Gregorio Marañón, IiSGM, Universidad Complutense, CIBERSAM, Madrid, Spain
                [ ]Division of Neuroscience, Ninewells Hospital and Medical School, Medical Research Institute, University of Dundee, Dundee, Scotland
                [ ]Department of Child and Adolescent Psychiatry/Psychotherapy, University of Ulm, Ulm, Germany
                [ ]FCRB, Department of Child and Adolescent Psychiatry and Psychology, Neurosciences Institute, Hospital Clínic of Barcelona, SGR1119, IDIBAPS, University of Barcelona, CIBERSAM, Barcelona, Spain
                [ ]School of Pharmacy, University College London, University of London, London, UK
                [ ]Department of Practice and Policy, Centre for Paediatric Pharmacy Research, UCL School of Pharmacy, London, UK
                [ ]Department of Pharmacology and Pharmacy, Centre for Safe Medication Practice and Research, University of Hong Kong, Pokfulam, Hong Kong
                [ ]Department of Neurosciences, UPC Katholieke Universiteit Leuven, Leuven, Belgium
                [ ]Unité Universitaire de Psychiatrie de l’Enfant et de l’Adolescent, Nantes, France
                [ ]INSERM U669, Maison de Solenn, Paris, France
                [ ]IRCCS Fondazione Stella Maris, Pisa, Italy
                [ ]IRCCS Children Hospital Bambino Gesu, Rome, Italy
                [ ]CIMH, Central Institute of Mental Health, Mannheim, Germany
                [ ]Department of Psychiatry, University of Groningen, Groningen, The Netherlands
                Article
                498
                10.1007/s00787-013-0498-3
                4246122
                24337449
                7908c356-dff9-4de9-b0d6-71c2c468026b
                © The Author(s) 2013

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution License which permits any use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.

                History
                : 28 April 2013
                : 13 November 2013
                Categories
                Original Contribution
                Custom metadata
                © Springer-Verlag Berlin Heidelberg 2014

                Clinical Psychology & Psychiatry
                conduct disorder,randomised clinical trials,risperidone,pharmacovigilance,psychopharmacology

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