Abstract

Real-world data suggest very low treatment response rates in clinical routine. The search for treatment personalization tools and potential moderators of clinical outcomes is ongoing. Therapeutic Drug Monitoring (TDM), i.e. the quantification of drug concentrations in plasma or serum to titrate the individual dose, is currently the only established personalized medicine tool. Analyzing large TDM datasets acquired as part of clinical practice can help addressing common clinical questions deriving from common clinical scenarios. This type of questions frequently refer to the treatment of particularly vulnerable patient subgroups, where different patterns of drug disposition are expected. For example, the mental healthcare of women in pregnancy or lactation can comprise a challenge for professionals involved including prescription of pharmacological agents. We use different types of data to understand the risk of mental distress in women during pregnancy and at postpartum, while we also focus on exposure of fetuses/newborns to pharmacotherapy prescribed to the mothers during pregnancy and lactation. Moreover, we are interested in understanding moderators of effectiveness and safety outcomes for well-established psychiatric therapies, including electroconvulsive therapy and psychotherapies.