Pharmacovigilance and therapeutic drug monitoring

Research projects of the ‘AG TDM’ aim to optimize the safety and effectiveness of drug therapies in children and adolescents with psychiatric disorders. Except for stimulants, most psychotropic drugs are not approved for children and adolescents and are administered off-label. However, kids are not “small adults”, which is why for example dosages or therapeutic concentration ranges cannot simply be derived from data from adults. Systematic research on the use of these drugs must also carried out for this age group.

Research in the TDM Lab

In the joint special laboratory for Therapeutic Drug Monitoring (TDM) of the Center for Mental Health at the UKW, we examine the relationships between dose, drug concentration, therapeutic effect and adverse drug reactions (ADRs) for various psychotropic drugs in use for different indications and patient groups. We also test the suitability of child-friendly, alternative matrices for measuring concentrations (for example saliva, tear fluid). Our working group has already been able to suggest age- and indication-specific therapeutic serum levels for children and adolescents for various frequently used substances.

Study TDM-VIGIL

In order to expand upon drug safety data for child and adolescent psychiatry using a prospective, systematic approach, the multicenter pharmacovigilance study 'TDM-VIGIL' (subproject 1 as a phase IIIb clinical trial, subproject 2 as an observational study) was carried out under the direction of our clinic. This project is funded by the Institute for Drugs and Medical Devices (BfArM). Epidemiological data from 1.200 children and adolescents treated with various psychotropic drugs were collected using standardized psychometric instruments.

Competence Network TDM

Our working group cooperates in a leading role with the “Competence Network TDM in Child and Adolescent Psychiatry”, an international research group of 42 child and adolescent psychiatric hospitals from five European countries and which operates an internet-based database (TDM patient registry). From the naturalistic data generated independently of the product-developing industry, treatment recommendations for optimized patient care should be derived as an essential supplement to the results of randomized controlled clinical trials.

Network Project KIDsafe

A drug information system is being introduced in various regions in Germany as part of the Network Projekt KIDsafe. This project aims to reduce inpatient stays in pediatric clinics due to side effects. The Clinic and Polyclinic for Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy (CAPPP) Würzburg is the only child and adolescent psychiatric consortium partner and is investigating the applicability of the information system to the psychopharmacological treatment of children and adolescents in a subproject. KIDsafe is supported by the Innovation Fund of the Federals Joint Committee (G-BA).