654. THE WPA/CINP STUDY ON TOOL DEVELOPMENT FOR PSYCHOSIS (WPA/CINP TOP STUDY): RATIONAL AND DESIGN

Abstract Background The reporting of adverse events in clinical trials of psychotropic medication is not standardized and as a consequence each group of authors reports them in an idiosyncratic way, with labels and definitions often conflicting or partially overlapping. This makes difficult the assessment of adverse events across studies and, of course, their meta-analysis. Additionally, there is no research on the relationship between the self reporting and the observer rating of adverse events. Aims & Objectives The primary aim of the study is to develop a novel scale for the assessment of pharmaceutical adverse events. This scale will be comprehensive and detailed, it will include all known adverse events caused by psychopharmacological agents and it will also include a self-report and a rater’s version. To our knowledge there is no self-report adverse events scale and it is unknown whether such a scale can be developed, what its reliability and validity would be and whether some adverse events can be self-reported while others cannot. Secondary aims are: Method Patients should be stabilized and receiving the same medication treatment for at least one month. Results at the stage of data gathering Discussion & Conclusions The data which will be gathered, will be used to validate a number of translations of the WPA/CINP adverse events scales, the PsycHe, the GloDiS, the RASS and the Neurocognitive battery. Secondary analyses will be determined in due course and will utilize the data to calculate a number of variables e.g. the accumulated burden in terms of chronicity of symptoms or duration of untreated psychosis etc. and investigate how these indices could relate to the long term outcome as it is reflected in the present state of the patients.