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PERS aims to increase the safety of off-label antipsychotics prescription to minors

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The Pediatric European Risperidone Studies (PERS) address the topic of the FP7-Health-4.2-1 work program “Adapting off-patent medicines to the specific needs of paediatric populations”. Risperidone, a second-generation antipsychotic, is 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.

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 on efficacy and tolerability for the use of risperidone in children and adolescents with conduct disorder and long term safety of risperidone in children and adolescents receiving risperidone for a variety of conditions.

disorder

What is conduct
disorder?

Some basic facts and figures

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News

July 11, 2013
The British regulatory agency MHRA put a recall on
our medicine for CONCA and DISCONCA (WP2, WP3)! Both short-term studies are on hold (no patients enrolled)!

November 2013
First
PERS publication accepted in European Child and Adolescent Psychiatry: Paediatric European Risperidone Studies (PERS): context, rationale, objectives, strategy, and challenges.

March 2014
Potential study sponsor (Janssen-Cilag) dropped off; no reproduction of the tablets for WP2 and WP3 possible.
Consortium strongly supports successfully ongoing observational naturalistic study. Recruitment is ongoing across a series of sites in Spain, Italy and France.

Summer 2014
German sites received ethics approvals and can start the observational study at both sites.
November 2014
The consortium cordially welcomes KCL, London, as new PERS WP4 recruitment site!
December 2014
Nearly 300 pediatric patients take part in our prospective observational trial. Recruitment is ongoing in The Netherlands, Germany, UK, Spain, France, and Italy!

Events

Conference calls

Past (2014)

  • January 6, 2014
  • February 10, 2014
  • March 10, 2014
  • April 8, 2014
  • May 5, 2014
  • June 2, 2104
  • July 7, 2014
  • (no TC in August)
  • September 1, 2014
  • October 6, 2014
  • November 3, 2014
  • December 1, 2014
  • January 12, 2015 (2nd Monday!)
  • February 2, 2015

Upcoming

  • March x 2015: RESCHEDULED!
New TC date not set; please check for update!