title: Pediatric psychopharmacological research in the post EU regulation 1901/2006 era.
abstract: Although the use of psychotropic medications in child and adolescent psychiatry in Germany is on the increase, most compounds are in fact prescribed "off-label" because of a lack of regulatory approval in these age groups. In 2007, the European Parliament introduced Regulation 1901/2006 concerning medicinal products in pediatric populations, with a subsequent amendment in the form of Regulation 1902/2006. The main aim of this legislation was to encourage research and clinical trials in children and adolescents, and thus promote the availability of medications with marketing authorization for these age groups. Furthermore, initiatives such as the European 7th Framework Program of the European Union now offer substantial funding for pediatric pharmacological research. At a recent Congress of the German Society for Child and Adolescent Psychiatry and Psychotherapy (DGKJP), experts from the field and the pharmaceutical industry held a symposium with lay representatives in order to discuss attitudes toward, and experience with, pediatric psychopharmacology research in Germany since 2007. Several areas of concern were identified. The present paper derives from that symposium and provides an overview of these opinions, which remain crucial to the field. A wider discussion of how to facilitate psychopharmacological research in Germany in order to optimize the treatment and welfare of children and adolescents with psychiatric disorders is now warranted.
authors.affiliation: Research Group for Pediatric Psychopharmacology, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg.
authors.forename: Christine
authors.initials: C
authors.lastname: Schmäl
authors.affiliation: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Faculty of Human Medicine, Philipps-University of Marburg.
authors.forename: Katja
authors.initials: K
authors.lastname: Becker
authors.affiliation: Research Group for Pediatric Psychopharmacology, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg.
authors.forename: Ruth
authors.initials: R
authors.lastname: Berg
authors.affiliation: Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, Pfalz Institute, <location>Klingenmünster</location>
authors.forename: Michael
authors.initials: M
authors.lastname: Brünger
authors.affiliation: Department of Child and Adolescent Psychiatry, University Hospital Cologne.
authors.forename: Gerd
authors.initials: G
authors.lastname: Lehmkuhl
authors.affiliation: Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy Practice, <location>Würzburg</location>
authors.forename: Klaus-Ulrich
authors.initials: KU
authors.lastname: Oehler
authors.affiliation: German Association of Research-Based Pharmaceutical Companies (vfa), <location>Berlin</location>
authors.forename: Thorsten
authors.initials: T
authors.lastname: Ruppert
authors.affiliation: Research Group for Pediatric Psychopharmacology, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg Ludwigshafen Association for Attention Deficit Hyperactivity Disorder, <location>Ludwigshafen</location>
authors.forename: Claus
authors.initials: C
authors.lastname: Staudter
authors.affiliation: Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy Practice, <location>Aschaffenburg</location>
authors.forename: Götz-Erik
authors.initials: GE
authors.lastname: Trott
authors.affiliation: Research Group for Pediatric Psychopharmacology, Department of Child and Adolescent Psychiatry and Psychotherapy, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg.
authors.forename: Ralf W
authors.initials: RW
authors.lastname: Dittmann
mesh_terms: D000293:Adolescent; D000296:Adolescent Psychiatry / Q000331:legislation & jurisprudence; D002648:Child; D002665:Child Psychiatry / Q000331:legislation & jurisprudence; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D003299:Cooperative Behavior; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D004345:Drug Industry / Q000331:legislation & jurisprudence; D005062:European Union; D005858:Germany; D006801:Humans; D033183:Interdisciplinary Communication; D001523:Mental Disorders / Q000188:drug therapy*; D056687:Off-Label Use / Q000331:legislation & jurisprudence; D011619:Psychotropic Drugs / Q000009:adverse effects* / Q000627:therapeutic use*
chemical_list: D011619:Psychotropic Drugs
keywords: Arzneimittelzulassung; Psychopharmakologische Forschung/Klinische Studien; marketing authorization; pediatric investigation plan; psychopharmacological research/clinical studies; pädiatrische Population; pädiatrischer Prüfplan; vulnerable/pediatric populations