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Clinical research in psychopharmacology: new standards for drug development. An application to antidepressants

Published online by Cambridge University Press:  28 April 2020

JD Guelfi
JD Guelfi*
Affiliation:
Clinique des maladies mentales et de l’encéphale (Pr B Samuel-Lajeunesse), hôpital Sainte-Anne, 100, rue de la Santé, 75014Paris, France
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Summary

This paper compares the report of the consensus conference on the methodology of clinical trials of antidepressants held in Zurich in 1988 with the second edition of the WHO Clinical Consensus Document. For the pilot trials, the dose-finding studies, the main therapeutic trials and the long-term trials, the following problems are discussed: inclusion and exclusion criteria, assessments of the severity of depression and of side-effects, measurement of change, recommended length of trials and criteria for the degree of response. It is important to obtain evidence to establish that antidepressants are sufficiently effective and well-tolerated over a long period of time to justify their continued use. At least 100 patients treated for a period of one year should be available. During these trials, self-rating scales for quality of life are useful as are reports of any severe drug reactions, forwarded to the National Adverse Drug Reaction Monitoring System.

Résumé

Résumé

L’article conforte les données de la conférence-consensus sur la méthodologie des essais cliniques des antidépresseurs de Zurich (1988) à la deuxième édition du document de consensus de l'organisation mondiale de la santé. Les problèmes suivants sont discutés au sujet des essais pilotes, des études de doses, des principaux essais d’efficacité et des études de maintenance: les critères d’inclusion et d’exclusion, les évaluations de la gravité de la dépression et les effets secondaires, l’évaluation du changement, la durée optimale des essais et les critères de la réponse thérapeutique. Il est important d'établir que les molécules antidépressives sont efficaces et ont une tolérance suffisante pour justifier leur emploi de façon prolongée. Un minimum de 100 patients traités pendant une année est nécessaire avant la mise sur le marché d’un nouvel antidépresseur. Au cours de ces études, des questionnaires d’autoévaluation destinés à apprécier la qualité de vie s'avèrent utiles, de même que le relevé de tout effet secondaire important, notifié du système national de pharmacovigilance.

Keywords

clinical researchantidepressantsclinical trialsrecherche cliniqueantidépresseursessais cliniques
Type
Review
Information
Psychiatry and Psychobiology , Volume 5 , Issue 5 , 1990 , pp. 289 - 294
Copyright
Copyright © European Psychiatric Association 1990

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References

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