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The PERS study Work packages WP04

WP04: Observational open label pharmacovigilance study of 1-year

Leader: UMCG / P Hoekstra

Primary Objective

To compare the 1-year course of Body Mass Index standardized score of patients newly prescribed risperidone and healthy comparison subjects.

Secondary Objectives

  1. To explore the frequency, nature, and course of subjectively reported symptoms possibly associated with the use of risperidone in patients newly prescribed risperidone in relation to medication variables (dosage, duration of treatment, discontinuation vs. continued use) and patients characteristics (type of mental disorder, age, socioeconomic status, genetic polymorphisms, IQ, clinical efficacy, and comedication).
  2. To explore the 1-year course of weight and height, bone density, electrocardiographic parameters, neuropsychological parameters, and blood laboratory parameters (i.e., sodium, potassium, chloride, bicarbonate, urea nitrogen, creatinine, full blood count, hematocrit, hemoglobin, Glycosylated Hemoglobin, liver function tests, fasting lipids [triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol], fasting blood glucose, fasting insuline, prolactin, and cortisol), of patients newly prescribed risperidone in relation to medication variables (dosage, duration of treatment, discontinuation vs. continued use) and patients characteristics (type of mental disorder, age, socioeconomic status, IQ, clinical efficacy, and comedication).
  3. To build up a cohort for future PUMA holder to conduct a long term post-marketing surveillance study (up to 25 years of age) of side effects, weight, and height of patients who have been treated with risperidone.
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