Secretary office:

Competence network "TDM KJP e.V."
Andrea Bäuerle
Clinic for child and youth psychiatry/ psychotherapy University of Ulm<
Steinhövelstr. 5
89075 Ulm

Tel.: (+49) 0731-500-61710
Email: Contact



Pharmacovigilance in children and adolescents

"Multicentre, large simple clinical trial (phase IIIb) on the (off-label-) use of antidepressants and antipsychotics in children and adolescents"

List of Testcenters

Rational pharmacotherapy is a challenging task in child and adolescent psychiatry. Increasing prescription numbers contrast with the uncertainties of safety and efficacy issues. The lack of clinical (authorization) trials often implies a non- age-specific use of drugs. However, young patients show particular metabolic conditions and a higher vulnerability for adverse drug reactions. Thus it seems mandatory to create age-specific pharmacological data about efficacy and safety of psychotropic drug use in minors. Legislation authorities became aware of this situation and introduced European and national scientific pharmacovigilance regulations and programmes accordingly in order to continuously evaluate the benefit-risk-ratio, detect, collect, minimize, and prevent adverse effects of drugs by appropriate measures, e.g. therapeutic drug monitoring. The ‘TDM-VIGIL’study, which is funded by the German Federal Institute for Drugs and Medical Devices (BfArM), is designed to collect epidemiological prescription and safety data of psychotropic drugs in children and adolescents using an internet-based data infrastructure (patient registry).

key words: pharmacovigilance, child and adolescent psychiatry, therapeutic drug monitoring, developmental psychopharmacology, quality assurance

List of Testcenters

Egberts K, Gerlach M, Plener P, Romanos M
Pharmakovigilanz in der Kinder- und Jugendpsychiatrie – eine Studie zum Therapeutischen Drug Monitoring (TDM-VIGIL) erweitert die Datenlage bei Antidepressiva und Antipsychotika. Bulletin zur Arzneimittelsicherheit 2018, 2: 4-12

Mehr Informationen finden Sie unter: TDM VIGIL Prüferinfo

TDM VIGIL Kurzinfo

In Kooperation mit dem Partnerprojekt "Pharmakovigilanz bei Gerontopsychiatrischen Patienten"
(Antrag des Instituts für Arzneimittelsicherheit in der Psychiatrie, AMSP, und der Medizinischen Hochschule Hannover; Projektleitung: Herr Prof. Bleich).

Gefördert durch das Bundesinstitut für Arzneimittel und Medizinprodukte, Bonn



Atypical neuroleptics in anorexia nervosa: a naturalistic observational study including measurement of serum concentrations