Ethical Problems and Design of Controlled Clinical Trials

  • H. Helmchen
Part of the Psychopharmacology Series book series (PSYCHOPHARM, volume 8)


Psychiatry is rather far away from the therapeutic ideal (Ehrlich’s therapia magna sterilisans): to achieve immediate and complete success in all patients with the disease for which the therapy is indicated (specific efficacy) with no undesired side effects (safety). Currently available psychiatric therapies achieve at best only moderate specific efficacy and safety, so therapy research in psychiatry is badly needed. The main tool for this is the controlled clinical trial. However, the vast number of trial types and designs indicates that there is no ideal for all questions, but only designs which are more or less appropriate for a specific question. Furthermore, a controlled clinical trial goes beyond the individual’s therapeutic help insofar as it is an experimental procedure for gaining new knowledge and a more rational basis for improvement of therapy. According to the Helsinki/ Tokyo Declaration this means a greater need for getting valid informed consent than in routine therapy. However, it is precisely from patients with psychiatric disorders that informed consent may be a particular problem. Although some psychiatric disorders may destroy the capacity of a patient to understand a given piece of information and to give valid consent, all psychiatrists know that this is, in contrast to common public opinion, by no means true of all psychiatric patients. Rather, in a considerable number of psychiatric patients the competency for full informed consent is reduced only transiently and/or partially, and in other patients full competency is maintained (Fletcher et al. 1985; Helmchen 1986a,b; Helmchen and Winau 1986).


Control Clinical Trial Ethical Problem Therapeutic Principle Efficacious Therapy Ethical Point 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.


Unable to display preview. Download preview PDF.

Unable to display preview. Download preview PDF.


  1. Angst J, Hippius H, Woggon B et al. (1989) Consensus conference on the methodology of clinical trials in antidepressants. Pharmacopsychiatry 22: 3–7CrossRefGoogle Scholar
  2. BMJFFG (Der Bundesminister für Jugend, Familie, Frauen und Gesundheit) (1987) Bekanntmachung von Grundsätzen für die ordnungsgemäße Durchführung der Klinischen Prüfung von Arzneimitteln. Bundesanzeiger no 243, p 16617, 30 Dez 1987Google Scholar
  3. Fletcher JC, Dommel FW Jr, Cowell DD (1985) Consent to research with impaired human subjects. IRB: A Review of Human Subjects Research 7 (6): 1–6Google Scholar
  4. Helmchen H (1986a) Aufklärung, Einwilligung. In: Müller C (ed) Lexikon der Psychiatrie, 2nd edn. Springer, Berlin Heidelberg New York, pp 79-80, 221 - 222Google Scholar
  5. Helmchen H (1986b) Ethische Fragen in der Psychiatrie. In: Kisker KP, Lauter H, Meyer J-E, Müller C, Strömgren E (eds) Psychiatrie der Gegenwart, vol 2: Krisenintervention, Suizid, Konsiliarpsychiatrie. Springer, Berlin Heidelberg New York, pp 310–368Google Scholar
  6. Helmchen H, Winau R (eds) (1986) Versuche mit Menschen. De Gruyter, Berlin, p 391Google Scholar
  7. Helmchen H, Kanowski S, Koch HG (1989) Forschung mit dementen Kranken: Forschungsbedarf und das Problem der Einwilligung. Eth Med 1: 83–98Google Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 1990

Authors and Affiliations

  • H. Helmchen
    • 1
  1. 1.Psychiatrische Klinik und PoliklinikFreie Universität BerlinBerlin 19Germany

Personalised recommendations