Hostname: page-component-78c5997874-dh8gc Total loading time: 0 Render date: 2024-11-05T08:11:40.788Z Has data issue: false hasContentIssue false
  • English
  • Français

Clinical evaluation of antidepressant drugs; Guidelines from authorities

Published online by Cambridge University Press:  18 September 2015

J.M. Keppel Hesselink
Get access Rights & Permissions [Opens in a new window]

Summary

Food and Drug Administration, World Health Organisation and Committee on Proprietary Medicinal Products have published guidelines with recommendations how to conduct clinical trials. The guidelines for the clinical evaluation of antidepressant drugs contain a great variety of recommendations how to design phase I, phase II and phase III trials. Especially the pharmaceutical industry will follow these guidelines as much as possible to make the chances to register a new chemical entity as optimal as possible. While FDA and CPMP guidelines are primarily meant to be read by representatives from the pharmaceutical industries, the WHO guidelines give mainly information for clinicians. For the psychiatrist with interest in clinical research on antidepressants it is mandatory to know about the existence of these different guidelines. Fundamental differences between the guidelines do not exist; the methodological and ethical problems concerning placebo-use and relapse-recurrence problems are especially emphasized in the CPMP-guidelines.

Keywords

antidepressantsregulationsguidelinesclinical researchantidepressivarichtlijnenklinisch geneesmiddelenonderzoek
Type
Research Article
Information
Acta Neuropsychiatrica , Volume 4 , Issue 3 , September 1992 , pp. 57 - 62
Copyright
Copyright © Scandinavian College of Neuropsychopharmacology 1992

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Literatuur

1.Pocock, SJ.Clinical trials. Chichester: Wiley & Sons 1983.Google Scholar
2.FDA. Guidelines for the clinical evaluation of antidepressant drugs. Rockville: Food and Drug administration 1977.Google Scholar
3.WHO. LCD.-10; draft of chapter V, mental and behavioural disorders. Geneve, WHO, division of mental health 1989.Google Scholar
4.Commission of the European Communities. The rules governing Medicinal Products in the European Community 1989;III:209–18.Google Scholar
5.Miura, S.Guideline for clinical evaluation of antianxiety drugs. Study group for preparation of guidelines. Japan 1988.Google Scholar
6.College ter Beoordeling van Geneesmiddelen. Antidepressiva. Aanbevelingen voor het opstellen van een deel IB van het registra-tiedossier. Leidschendam 1989.Google Scholar
7.Angst, J, Beck, P, et al.Consensus Conference on te methodology of clinical trials of antidepressants. Pharmacopsychiat 1989;22:3–7.CrossRefGoogle Scholar
8.Amaducci, L, Angst, J, et al.Consensus Conference on the methodology of clinical trials of ‘Nootropics’. Pharmacopsychiat 1990;23:171–5.CrossRefGoogle ScholarPubMed
9.Praag van, HM.Psychofarmaca. Assen: van Gorcum 1977.Google Scholar
10.Riesen van, H, Segal, M.Comparative evaluation of rating scales for clinical psychopharmacology. Amsterdam: Elsevier 1988.Google Scholar
11.Collegium Internationale Psychiatrae Scalarum (CIPS). Internationale Skalen für Psychiatrie. Weinheim: Beltz test 1986.Google Scholar
12.Diagnostic and Statistical manual of mental disorders. Third revised edition. Washington: APA 1987.Google Scholar
13.Ministry of Health of the U.S.S.R. (Department for the Introduction of New Drugs and Medical Techniques, Pharmacological Committee). Methodological Guidelines for the Clinical Investigation of New Psychotropic Drugs. Moskou 1976.Google Scholar
14.Dreyfus, JF, Cremniter, D, Guelfi, JD.Reflections on FDA and WHO recommendations concerning clinical trials. Psychiat Psychobiol 1989;4:117–22.CrossRefGoogle Scholar
15.Montgomery, SA.Prophylaxis in recurrent unipolar depression: a new indication for treatment studies. J Psychopharm 1989;3:47–53.CrossRefGoogle ScholarPubMed
16.Doogan, P.De residual symptoms predict relapse in longterm treatment?British Association for Psychopharmacology, Annual meeting 21-24 07, 1991:142.Google Scholar
17.Department of health and human services Public Health Service, FDA. NDA-191839 sertraline: safety and efficacy. Pychopharmacological drug advisory committee, 11 19, 1990. Rockville, Maryland.Google Scholar
18.Montgomery, SA, Dufour, H, Brion, S, Gailledreau, J, e.a. The prophylactic efficacy of fluoxetine in unipolar depression. Br J Psychiat 1988;3:69–76.CrossRefGoogle Scholar
19.Stanley, B, Traskman-Bendz, L, Stanley, M.The suicide assessment scale: a scale evaluating change in suicidal behavior. Psychopharm Bull 1988; 22:200–5Google Scholar
20.Kreitman, N, Forster, J.The construction and selection of predictive scales, with special reference to parasuicide. Br J Psychiat 1991; 159:185–92CrossRefGoogle ScholarPubMed
21.Beck, AT, Kovacs, M, Weissman, A.Assessment of suicidal intention: the scale for suicide ideation. J consult clin Psychol 1979; 47:343–52CrossRefGoogle ScholarPubMed
22.Montgomery, SA.The methodology necessary to establish the long-term efficacy of antidepressants. In Hindmarch, I, Stonier, PD (red) Human Psychopharmacology. Chicester:Wiley, 1990; III:73–88.Google Scholar
23.Yohn, I, red. Getting your drug approved: FDA's own guidelines. Arlington: Washington Business Information 1990.Google Scholar