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PERS for "laymen”

Rationale
Aims and objectives
Participants
Work packages

Rationale

The Pediatric European Risperidone Studies address the topic of the FP7-Health-4.2-1 work program ‘Adapting off-patent medicines to the specific needs of paediatric populations”. Risperidone, is a second-generation antipsychotic, widely prescribed to children and adolescents in a variety of conditions such as psychotic disorders, externalizing symptoms associated with autism or mental retardation, aggressive behavior in disruptive behavior disorders. Prescription levels of second-generation antipsychotics in children and adolescents increase in both US and Europe and risperidone is most often prescribed in this class of molecules. Efficacy and safety of risperidone have been documented in children and adolescents with disruptive behavior and mild mental retardation in acute and maintenance trials but there is insufficient data available in patients with conduct disorder and an average IQ (85 and above). Long-term safety of risperidone regardless of prescription indications is also a matter of concern since children and adolescents seem particularly vulnerable to side effects such as weight gain and heightened levels of glucose and lipids. To improve our understanding of treatment effects, factors that potentially influence clinical response and tolerability to risperidone have to be studied along with efficacy and tolerability issues.

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Aims and objectives

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. Main aims and objectives of PERS are the following:

  • To examine the short-term efficacy and safety of risperidone in children and adolescents with CD and normal IQ by performing a 12 week trial comparing risperidone to placebo.
  • To examine maintenance of clinical response to risperidone in children and adolescents with CD and normal IQ by performing a discontinuation study in patients who had previously had a stable open-label response of at least 12 weeks duration. Maintenance of improvement is compared between a group continuing on risperidone and another switched to placebo.
  • To study long-term safety of risperidone in a 1 year longitudinal naturalistic prospective pharmacovigilance study. This study will include children and adolescents treated with risperidone for any indication.
  • To study moderating factors of risperidone treatment effect (baseline characteristics influencing therapeutic response) and to analyze 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.

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Participants

The PERS project arises from the collaboration of a group of experts in paediatric psychopharmacology within the framework of the European Child and Adolescent Network (ECAPN). ECAPN is supported by the European College of Neuropsychopharmacology (ECNP) (www.ecnp.eu).

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Work packages

WP1: Project management

Main tasks: Overall coordination of contractual, financial, legal, administrative and scientific issues.

WP2: Short-term  efficacy trial on risperidone in conduct disorder

Primary objective: to test the hypothesis that risperidone given orally in a dose of 0,02-0,06 mg/kg/d for 12 weeks is superior to placebo in reducing disruptive behavioral symptoms associated with DSM-IV defined conduct disorder in children and adolescents with normal IQ.

WP3: Relapse prevention in children and adolescents with conduct disorder and a maintained response: a double-blind discontinuation trial

Primary objective: to test the hypothesis that, after seven month of daily administration, risperidone is superior to placebo in preventing relapse of symptoms of conduct disorder, as assessed through a 12-week, double-blind discontinuation trial.

WP4: Observational open-label pharmacovigilance study

Primary objective: to investigate the long-term safety of risperidone in a 1-year longitudinal naturalistic prospective pharmacovigilance study. The study will include children and adolescents treated with risperidone for any indication, including CD, schizophrenia, and autism spectrum disorders.

WP5: E-technology and data capture

Main task: adapt an on-line multi-media suite of questionnaires to the use of the risperidone pharmacovigilance study.

WP6: Ethics

Main Task: developing the ethical aspects PERS in accordance with EU and national legislations.

WP7: Training

Provide Good Clinical Practice training and certification for personnel involved in data collection.

WP08: Regulatory issues

The aim of this WP is to provide information necessary to fulfil and comply with the regulatory requirements of the entire project.

WP9: Dissemination

Main task: disseminate PERS progress and results.

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