Pharmacopsychiatry 2005; 38 - A161
DOI: 10.1055/s-2005-918783

Placebo-controlled studies on antidepressants

HJ Möller 1
  • 1Ludwig-Maximilians-Universität LMU München, Klinik und Poliklinik für Psychiatrie und Psychotherapie, München

Placebo-controlled studies in the area of clinical psychopharmacology in Germany do not have reached sufficient acceptance until to date, despite the fact that this acceptance has been claimed by the Food and Drug Administration–FDA and the European Admission Agency EMEA for antidepressants, anxiolytic agents, antipsychcotics and antidementiva. This problem will be described from different view-points exemplary for antidepressants. The need of placebo-controlled studies and their ethical apology and aspects of safety will be presented in particular with respect on medical and scientific terms. It will be discussed which possible negative impact the German resistance toward the realisation of placebo-controlled studies will have on the scientific site in the field of clinical psychopharmacology in Germany in the long run. The aim of the symposium is to support a better understanding in the necessity of placebo-controlled trials and the attempt to decrease the existing concerns against medical risks or ethical objections in Germany.