[Principles and regulations for clinical pilot studies on psycholeptic drugs (author's transl)].
Some difficulties concerning the patient selection for psychopharmacological trials are described. Problems, decisive factors and methodological principles are discussed, especially the duration of clinical trials and the placebo problem.
D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D004341:Drug Evaluation / Q000592:standards*; D006801:Humans; D010865:Pilot Projects / Q000592:standards; D010919:Placebos; D011619:Psychotropic Drugs / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D012107:Research Design
D010919:Placebos; D011619:Psychotropic Drugs
Grundlagen und Richtlinien für erste klinische Psychopharmaka-Prüfungen (Phase I, II) aus der Sicht des klinischen Prüfers.