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Eur Neuropsychopharmacol. 2015 Oct;25(10):1513-31. doi: 10.1016/j.euroneuro.2015.06.009. Epub 2015 Jun 20.

Unmet needs in paediatric psychopharmacology: Present scenario and future perspectives.

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Child & Adolescent NeuroPsychiatry Unit, University Campus Bio-Medico, Rome, Italy; Mafalda Luce Center for Pervasive Developmental Disorders, Milan, Italy. Electronic address:
Child and Adolescent Psychiatry Department, Hospital General Universitario Gregorio Marañón, School of Medicine Universidad Complutense, IiSGM, CIBERSAM, Madrid, Spain.
Department of Cognitive Neuroscience, Donders Institute for Brain, Cognition and Behaviour, Radboud University Medical Centre, and Karakter Child and Adolescent Psychiatry University Centre, Nijmegen, The Netherlands.
Psychiatry Research, The Zucker Hillside Hospital, North Shore-Long Island Jewish Health System, Glen Oaks, NY, USA.
Department of Psychiatry, University of Groningen, University Medical Center, Groningen, The Netherlands.
National Institute of Mental Health, Bethesda, MD, USA.
Department of Psychiatry, Brain Center Rudolf Magnus, University Medical Center Utrecht, Utrecht, The Netherlands.
Dept. Biomedical Sciences, Child & Adolescent NeuroPsychiatry Unit, University of Cagliari, Cagliari, Italy.


Paediatric psychopharmacology holds great promise in two equally important areas of enormous biomedical and social impact, namely the treatment of behavioural abnormalities in children and adolescents, and the prevention of psychiatric disorders with adolescent- or adult-onset. Yet, in striking contrast, pharmacological treatment options presently available in child and adolescent psychiatry are dramatically limited. The most important currently unmet needs in paediatric psychopharmacology are: the frequent off-label prescription of medications to children and adolescents based exclusively on data from randomized controlled studies involving adult patients; the frequent lack of age-specific dose, long-term efficacy and tolerability/safety data; the lack of effective medications for many paediatric psychiatric disorders, most critically autism spectrum disorder; the scarcity and limitations of randomized placebo-controlled trials in paediatric psychopharmacology; the unexplored potential for the prevention of psychiatric disorders with adolescent- and adult-onset; the current lack of biomarkers to predict treatment response and severe adverse effects; the need for better preclinical data to foster the successful development of novel drug therapies; and the effective dissemination of evidence-based treatments to the general public, to better inform patients and families of the benefits and risks of pharmacological interventions during development. Priorities and strategies are proposed to overcome some of these limitations, including the European Child and Adolescent Clinical Psychopharmacology Network, as an overarching Pan-European infrastructure aimed at reliably carrying out much needed psychopharmacological trials in children and adolescents, in order to fill the identified gaps and improve overall outcomes.


Autism spectrum disorder; Biomarkers; Intellectual disability; Off-label use; Pharmaceutical policies; Psychopharmacology

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