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