title: [Ethical implications of placebo-controlled clinical trials for psychotropic drugs].
abstract: The "note of clarification" of the World Medical Association to Article 29 of the Fifth Revision of the Declaration of Helsinki (Edinburgh 2000) intensified the controversial discussion of how methodologically compelling and ethically acceptable pure placebo controls are in clinical trials of new drugs if an effective standard therapy ("active control") is available. Pros and cons from this discussion are exposed and examined with regard to "minor" psychic disorders, depressions, and schizophrenia. Criteria are developed to facilitate the evaluation of each trial application. These criteria also seem to be necessary because normative authorities, which are responsible for licensing drugs such as FDA and EMEA, and legally relevant regulations such as the additional protocol for biomedical research of the European Council do not agree with regard to placebo controls. It is concluded that pure placebo-controlled clinical trials of new psychotropic drugs may be acceptable in minor psychic disorders, but in general -- at least in a pure form -- not in major disorders such as schizophrenia and major depression.
authors.affiliation: Klinik für Psychiatrie und Psychotherapie, Charité -- Universitätsmedizin Berlin, Freie Universität Berlin.
authors.forename: H
authors.initials: H
authors.lastname: Helmchen
mesh_terms: D018849:Controlled Clinical Trials as Topic / Q000941:ethics*; D017277:Drug Approval; D028744:Ethics Committees, Research; D006381:Helsinki Declaration; D006801:Humans; D038622:Internationality; D001523:Mental Disorders / Q000188:drug therapy*; D015990:Placebo Effect; D010919:Placebos; D011619:Psychotropic Drugs / Q000627:therapeutic use*
chemical_list: D010919:Placebos; D011619:Psychotropic Drugs