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Paediatric European Risperidone Studies

Objective

Second-generation antipsychotics are increasingly being prescribed to children and adolescents. Their use, however, is mostly off-label, and adequate and sufficient data about efficacy and particular safety are lacking. This proposal focuses on two indications, the use of risperidone in children and adolescents with conduct disorder who are not mentally retarded, and the use of risperidone in adolescents with schizophrenia. The objectives are to 1) perform a series of clinical studies that will provide sufficient information for a Paediatric Use Marketing Authorisation to be obtained for these indications; 2) address scientific questions about the moderating and/or mediating factors of the efficacy and safety of risperidone in children and adolescents, and 3) disseminate the knowledge acquired by the proposed studies to medical and mental health professionals, to patients and their families and society in general.

Call for proposal

FP7-HEALTH-2009-single-stage
See other projects for this call

Funding Scheme

CP-FP - Small or medium-scale focused research project

Coordinator

STICHTING KATHOLIEKE UNIVERSITEIT
Address
Houtlaan 4
6525 XZ Nijmegen
Netherlands
Activity type
Higher or Secondary Education Establishments
EU contribution
€ 811 360
Administrative Contact
Maarten Van Langen (Mr.)

Participants (20)

ACADEMISCH ZIEKENHUIS GRONINGEN
Netherlands
EU contribution
€ 418 800
Address
Hanzeplein 1
9713 GZ Groningen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Pieter J Hoekstra (Dr.)
ZENTRALINSTITUT FUER SEELISCHE GESUNDHEIT
Germany
EU contribution
€ 455 400
Address
Square J 5
68159 Mannheim
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ralf Dittmann (Prof.)
University College London
United Kingdom
EU contribution
€ 284 600
Address
Gower Street
WC1E 6BT London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Greta Borg-Carbott (Ms.)
UNIVERSITY OF DUNDEE
United Kingdom
EU contribution
€ 182 640
Address
Nethergate
DD1 4HN Dundee
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Neil Stewart (Mr.)
THE SCHOOL OF PHARMACY, UNIVERSITY OF LONDON
United Kingdom
EU contribution
€ 164 080
Address
Brunswick Square 29-39
WC1N 1AX London
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Ian Ck Wong (Prof.)
ASSISTANCE PUBLIQUE HOPITAUX DE PARIS
France
EU contribution
€ 201 720
Address
3 Avenue Victoria
75000 Paris
Activity type
Research Organisations
Administrative Contact
Christophe Misse (Mr.)
SERVICIO MADRILENO DE SALUD
Spain
EU contribution
€ 153 640
Address
Plaza Carlos Trias Bertran 7
28020 Madrid
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Administrative Contact
Albino Navarro Izquierdo (Dr.)
FUNDACIO CLINIC PER A LA RECERCA BIOMEDICA
Spain
EU contribution
€ 181 500
Address
Carrer Rossello 149
08036 Barcelona
Activity type
Research Organisations
Administrative Contact
Emili Bargallo (Mr.)
UNIVERSITA DEGLI STUDI DI CAGLIARI
Italy
EU contribution
€ 372 460
Address
Via Universita 40
09124 Cagliari
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Giuseppina Tore (Ms.)
KATHOLIEKE UNIVERSITEIT LEUVEN
Belgium
EU contribution
€ 51 600
Address
Oude Markt 13
3000 Leuven
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Maria Vereeken (Ms.)
Fondazione Stella Maris
Italy
EU contribution
€ 135 660
Address
Viale Del Tirreno 331
56118 Pisa
Activity type
Research Organisations
Administrative Contact
Roberto Cutajar (Dr.)
OSPEDALE PEDIATRICO BAMBINO GESU
Italy
EU contribution
€ 154 080
Address
Piazza Sant Onofrio 4
00165 Roma
Activity type
Other
Administrative Contact
Stefano Vicari (Prof.)
INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE
France
EU contribution
€ 56 400
Address
Rue De Tolbiac 101
75654 Paris
Activity type
Research Organisations
Administrative Contact
Annick Bertault (Ms.)
UNIVERSITAET ULM
Germany
EU contribution
€ 368 960
Address
Helmholtzstrasse 16
89081 Ulm
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Frank Gleixner (Mr.)
WOCKHARDT UK LTD
United Kingdom
Address
Ash Road North, Wrexham Industrial Estate
LL139UF Wrexham
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ashish Kakabalia (Mr.)
SERMES PLANIFICACION
Spain
EU contribution
€ 352 305
Address
Calle Rufino Gonzalez 14
28037 Madrid
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Antonio Berlanga (Mr.)
Medicomp Gesellschaft fuer Versuchsplanung und Datenanlyse mbH
Germany
EU contribution
€ 269 505
Address
Ordenslandstrasse 11
82140 Olching
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Michael Gierend (Dr.)
MediServ BV
Netherlands
EU contribution
€ 411 830
Address
De Stadspoort 32
5611 GZ Eindhoven
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Odette Jochems (Dr.)
CAMPBELL CHARLES ASSOCIATES (2000)LIMITED
United Kingdom
EU contribution
€ 242 370
Address
Station Road 48
KT11 3BN Stoke D Abernon
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Ignazio Di Giovanna (Dr.)
Dimensione Ricerca S.r.l.
Italy
EU contribution
€ 331 090
Address
Viale Dei Parioli 12
00197 Rome
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Administrative Contact
Andrea Sgrignani (Mr.)