PERS Observational
Research type
Research Study
Full title
Paediatric European Risperidone Studies: Observational pharmacovigilance study
IRAS ID
159151
Contact name
David Coghill
Contact email
Sponsor organisation
University of Dundee
Eudract number
2011-000567-26
Research summary
Risperidone is frequently used off label to treat conduct disorder in children and adolescents. PERS Observational is a multicentre, observational pharmacovigalance study designed to investigate the long-term safety (up to one year) of risperidone or aripiprazole treatment for any condition in 520 paediatric subjects, aged between 5 and 17 years. In routine child and adolescent psychiatric practice typical indications will include but are not limited to conduct disorder, schizophrenia, and autism spectrum disorders. All treatment decisions will be made by the direct care team, any possible co-medication will be allowed. Clinicians are free to decide to change or discontinue treatment with risperidone or aripiprazole at any time. Primary outcome measure will be the course of Body Mass Index (BMI) standardized score. Secondary outcomes include the frequency, nature, and course of subjectively reported symptoms, the course of weight and height, waist circumference; and blood laboratory parameters (i.e., glycosy-lated haemoglobin A1, liver enzymes, fasting lipids [triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol], fasting blood glucose, fasting insulin, prolactin). For those new to medication measures will be taken prior to treatment and after 1, 2, 3, 6, and 12 months of treatment. For those already on treatment we measures will be collected at inclusion into the study and after 6 and 12 months. All measures reflect standard clinical practice as recommended by current guidelines. The study will be conducted at 14 sites across Europe (Netherlands, Germany, UK, France, Spain, Italy, Belgium).
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
14/YH/1104
Date of REC Opinion
29 Jul 2014
REC opinion
Favourable Opinion