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The PERS study Aims of the PERS study

Aims of the PERS study

Therefore, the overarching goal of this application is to perform a series of clinical studies that will lead to a Paediatric Use Marketing Authorisation (PUMA) for risperidone in children and adolescents with CD.

Objectives

The key objectives of this project are to:

  1. Perform a series of clinical studies that will provide sufficient information for a Paediatric Use Marketing Authorisation (PUMA) to be obtained for the use of risperidone in CD in children and adolescents. The request for the PUMA will be submitted by Wockhardt which is an international pharma company included in this consortium as a partner.
  2. Address scientific questions about the moderating and/or mediating factors of the short-term efficacy and maintainance of clinical response, and the short-term and long-term safety of risperidone in children and adolescents with CD, and the long-term safety of risperidone in children and adolescents with psychiatric disorders. Moderators identify in whom and under which circumstances treatment have different effects (e.g. initial conditions). Mediators identify why and how treatments have effect or side-effects do occur (mechanisms of treatment and of tolerability).
  3. Disseminate the extension of 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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