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Content archived on 2024-06-18

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
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Coordinator

STICHTING RADBOUD UNIVERSITEIT
EU contribution
€ 811 360,00
Address
HOUTLAAN 4
6525 XZ Nijmegen
Netherlands

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Region
Oost-Nederland Gelderland Arnhem/Nijmegen
Activity type
Higher or Secondary Education Establishments
Administrative Contact
Maarten Van Langen (Mr.)
Links
Total cost
No data

Participants (20)