Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation
Other

If ‘other’, further details on the scope of the study

Pharmacovigilance
Non-interventional study

Non-interventional study design

Cohort
Other

Non-interventional study design, other

Intensive monitoring schemes, pharmacokinetic study, pharmacodynamic study, drug interaction study
Population studied

Age groups

Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

4000
Study design details

Main study objective

The purpose of this observational multicenter-study is to investigate safety of psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. We also aim to validate a rating-scale for adverse events in geriatric psychiatric patients(GAERS) and analyse special risk factor combinations in eldery patients to develop risk managment plans.

Outcomes

Assessment of frequency and severity of adverse events in geriatric psychiatry inpatients under psychopharmacological treatment, - demographic data- laboratory results, ECG, physical examination- Assessment of cognitive functioning- Quality of life - Adverse drug reactions- serum levels of substances- drug combination analysis

Data analysis plan

With bivariate analysis procedures (for example univariat logistic regression) impact of different drug combinations on frequency of possbile adverse drug reaction will be analysed. To develop risk-scores (demographic data, previous disorders, etc.) multivariate logistic regression modelling respectively Cox- regression and backward selection (using Akaike information criterion (AIC) and Bayesian information criterion), alternatively Classification and Regression Tree Analysis (CART) will be used.For validation of risk modells cross-validation technique and bootstrapping will be used.