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About PERS Project Summary

Project Summary

Background

Risperidone (a 2nd generation atypical antipsychotic drug (APD)) is increasingly prescribed off-label to children and adolescents both for psychotic and non-psychotic disorders (e.g. Conduct disorder, autism, etc.).

Children and adolescents are more at risk for the metabolic and endocrinologic side effects of APDs.

However detailed short- and long-term safety and efficacy data of APDs including Risperidone is lacking in children and adolescents.

The PERS consortium aims to address this.

Objectives

To examine the short-term efficacy and safety of risperidone in children and adolescents with CD and normal IQ by performing a 12 week randomized placebo-controlled double-blind clinical trial.

To examine maintenance of clinical response to risperidone in children and adolescents with CD and normal IQ by performing a placebo-controlled discontinuation study in patients who had previously had a stable open-label response of a t least 12 weeks duration.

To study long-term safety of risperidone in a 1 year longitudinal naturalistic prospective pharmacov igilance study. This study will include children and adolescents treated with risperidone for any indication, including CD and schizophrenia.

To study moderating factors of risperidone treatment effect (baseline characteristics influencing therapeutic response) and to analyse to what extent clinical improvement is mediated by change in cognitive profiles.

To study tolerability of risperidone and individual, medication and life-style factors associated with side effects.

To gain evidence for developing new and updating existing clinical guidelines and practice parameters for the treatment of CD in children adolescents.

Summary of the PERS project

The PERS project addresses major gaps in the evidence-base of the use of risperidone for the treatment of conduct disorder in children and adolescents. PERS proposes 3 clinical studies that will provide information in order to obtain a Paediatric Use Marketing Authorization (PUMA), for the use of risperidone in children and adolescents with conduct disorder.

The project consists of 9 Workpackages (WPs).

PERS in addition to having three primary clinical workpackages (WP2, WP3 and WP4) is supported by both a general assembly (which is the final decision making authority), an executive board, scientific, medical and ethical advisory boards and a project management team. Additional workpackages (WPs) are led by experts in the fields of electronic technology and data capture (WP5), ethics (WP6), training (WP7), regulatory affairs (WP8) and dissemination (WP9).

  • WP-1 Project Management
  • WP-2 Short term efficacy trial on RIS in CD
  • WP-3 Long term efficacy study in children and adolescents with CD
  • WP-4 Observational openlabel pharmacovigilance study
  • WP-5 Electronic technology and data capture
  • WP-6 Ethics
  • WP-7 Training
  • WP-8 Regulatory activities
  • WP-9 Dissemination
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