Paediatric European Risperidone Studies
Start date: May 1, 2010,
End date: Apr 30, 2015
"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."
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