¹Aristotle University of Thessaloniki, 3rd Department of Psychiatry, Thessaloniki, Greece

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:

• The validation of a structured interview and a precise method for the registration of previous psychiatric history of patients (anamnestic),
• The validation of a scale for the assessment of global disability
• The validation of a scale for the assessment of suicidal risk
• The development of a new battery for the assessment of neurocognitive function with focus on mental disorders

Method: 

1. Study sample

1. Diagnosis: schizophrenia, schizoaffective or bipolar disorder according to DSM-5.

Patients should be stabilized and receiving the same medication treatment for at least one month.

1. Exclusion criteria: any somatic disorder
2. Number of patients which will be recruited per center: at least 100

1. Method
   

• The WPA/CINP adverse events scales are two scales one in the form of a self-report scale and the other in the form of rater’s scoring. Both facets include all known adverse events which can be caused by psychopharmacological agents. The study will test these scales for the first time and will validate their translation in a number of languagesEach center will contribute with at least 100 patients, preferably with a balanced frequency of diagnosis
• For these patients, at least a 25% will be re-tested within a week with the self-report scales and with another rater for the rater-scored tools under validation.

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.