TDM-VIGIL

Pharmacovigilance in psychiatric patients in childhood and adolescence

Using an internet-based patient registry, this multicenter study project systematically collected information on the prescribing behavior of psychotropic drugs in children and adolescents. The TDM-VIGIL study (TDM: short for Therapeutic Drug Monitoring, VIGIL: from Pharmacovigilance) consisted of 2 subprojects:

Subproject 1 comprised a clinical trial according to the Medicines Act on the (off-label) use of antidepressants and antipsychotics in children and adolescents aged 4 to 18 years (EudraCT number 2013-004881-33).
The aim of subproject 2, an observational study, was to investigate drug-related risks of psychostimulants in children and adolescents aged 6 to 18 years with hyperkinetic disorder.

Funding: Federal Institute for Drugs and Medical Devices (BfArM)

Contact

If you have any questions or are interested in the project, please feel free to contact us at:

E-mail address: Elena.Mueller@med.uni-tuebingen.de

frontend.sr-only_#{element.contextual_1.children.icon}: +49 7071-29-80712

Methodology

Subproject 1: The course of therapy of children and adolescents with different psychiatric disorders who were treated on-label and/or off-label with an antidepressant and/or an antipsychotic was followed by means of systematic patient and therapeutic drug monitoring, i.e. including the measurement of serum concentrations of the drugs and the assessment of positive as well as negative clinical effects. In addition to the findings on the risk-benefit ratio of psychotropic drugs in childhood and adolescence, the data generated provide information on indications of possible age- or indication-specific therapeutic concentration ranges.
Subproject 2: The course of therapy of children and adolescents treated with psychostimulants and other medications to treat ADHD was followed by means of systematic patient monitoring and positive and negative clinical effects were documented. The data generated will be used to gain insights into the risk-benefit ratio of psychostimulants in childhood and adolescence.

Project team

Prof. Dr. Tobias Renner
Dr. Gottfried Maria Barth, M.A.
Prof. Dr. Annette Conzelmann
Eva Sitz
Dr. Helen Spieles
Dr. Katherine Schweitzer
Bernd Gomeringer
Elena Müller
Maria Oberbeck (student assistant)

Collaboration Partner:

Clinical trial director:

Prof. Marcel Romanos, MD,

Scientific Project Manager Subproject 1:

Dr. med. Karin Egberts, Center for Mental Health, Clinic and Polyclinic for Child and Adolescent Psychiatry Psychosomatics and Psychotherapy, University Hospital Würzburg.

Margarete-Höppel-Platz 1, 97080 Würzburg