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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

Référencés

American Psychiatric Association (1980) DSM III. Diagnostic and Statistical Manual of Mental Disorders. Washington DC (traduction française: Pichot, P, Guelfi, JD et at, 1983) 535 p, Masson, ParisGoogle Scholar
American, Psychiatric Association (1987) Diagnostic and Statistical Manual of Mental Disorders. Third Edition, Revised, Washington DC, APA (traduction française Guelfi, JD et al, 1989), 567 p, Masson, ParisGoogle Scholar
Angst, J, Bech, P, Boyer, P, Bruinyels, J, Engel, R, Helmchen, H, Hippins, H, Lingjaerde, O, Racagni, G, Saletu, B, Vedvall, G, Silverstone, JT, Stephancs, CN, Stoll, K, Wogger, B (1989) Consensus Conference on the Methodology of Clinical Trials of Antidepressants, Zurich, March 1988. Report of the Consensus Committee. Pharmacopsychiatry 22, 3 -7CrossRefGoogle Scholar
Asberg, M, Thoren, P, Traskman, L, Bertilsson, L, Ringberger, V (1976) Serotonine depression. A Biochemical subgroup within the affective disorders Science 191, 478-480Google Scholar
Asberg, M, Montgomery, SA, Perris, C, Schalling, D, Sedvall, G (1978) A Comprehensive Psychopathological Rating Scale. Acta Psychiatr Scand (suppl) 271,5–27CrossRefGoogle Scholar
Ban, TC (1987) Prolegomenon to the clinical prerequisite: Psychopharmacology and the classification of mental disorders. Prog Neuro-Psycliopharmacol & Biol Psychiatry 11, 527-580CrossRefGoogle ScholarPubMed
Beck, AT, Ward, CH, Mendelson, M, Mock, J, Erbauch, J (1961) An inventory for measuring depression. Arch Gen Psychiatry 4, 561-571CrossRefGoogle ScholarPubMed
Bloom, PM, Bradh, JP (1968) An ipsative validation of the Multiple Affect Adjective Check-list. J Clin Psychol 24, 45-463.0.CO;2-0>CrossRefGoogle ScholarPubMed
Bobon, D (1981) Le système AMDP, 2e ed, Mardaga, Bruxelles, 152 pGoogle Scholar
Bobon, D, Baumann, U, Angst, J, Helmchen, H, Hippius, H (1983) The AMDP-system in pharmacopsychiatry. In: Modem Probtems in Pharmaco-Psychiatry, Vol 20, Karger, BaselGoogle Scholar
Burdock, EI, Hakerem, G, Hardesty, AS, Zubin, J (1960) A word behaviour scale for mental hospital patients. J Clin Psychol 16, 246-2473.0.CO;2-Y>CrossRefGoogle Scholar
Clyde, DJ (1963) Manual for the Clyde Mood Scale. Biometrie Laboratory, Miami, FloridaGoogle Scholar
Derogatis, LR, Lipman, RS, Rickels, K, Uhlenhuth, EH, Covi, L (1974) The Hopkins Symptom Check List (HSCL). A measure of Primary Symptom Dimensions. In : Psychological Measurements in Psychopharmacology. Modern Problems in Pharmacopsychiatry, (Pichot, P, ed) vol 7, Karger, Basel, 79–110Google Scholar
Derogatis, LR (1977) SCL 90-R : Administration Scoring and Procedure Manual, Johns Hopkins, Baltimore MDGoogle Scholar
Direction de la Pharmacie et du Médicament (1987) Bonnes Pratiques Cliniques. Direction des Journaux officiels, ParisGoogle Scholar
Dreyfus, JF, Cremniter, D, Guelfi, JD (1989) Reflections on FDA and WHO Recommendations concerning Clinical Trials. Psychiatr & Psychobiol 4, 117-122Google Scholar
Endicott, J , Spitzer, RL (1978) A diagnostic interview : The schedule for affective disorders and schizophrenia. Arch Gen Psychiatry 35, 837-844CrossRefGoogle Scholar
Farmer, AE, Katz, R, Mc, Guffin P, Bebbington, P (1987) A comparison between the present State examination and the composite international diagnostic interview. Arch Gen Psychiatry 44, 1064-1068CrossRefGoogle ScholarPubMed
FDA (1977) Guidelines for the clinical evaluation of antidepressant drugs, US Dept of Health, Education and WelfareGoogle Scholar
Fawcett, J, Clark, DC, Scheftner, WA, Gibbons, RD (1983) Assessing anhedonia in psychiatrie patients. Arch Gen Psychiatry 40, 79-84CrossRefGoogle Scholar
Feighner, JP, Robins, E, Guze, SB, Woodruff, RA, Winokur, G, Munoz, R (1972) Diagnostic criteria for use in psychiatrie research. Arch Gen Psychiatry 26, 57-63CrossRefGoogle Scholar
Guelfi, JD, Dreyfus, JF, Pull, CB (1978) Les essais thérapeutiques en psychiatrie: méthodologie, éthique et législation, Masson, ParisGoogle Scholar
Guelfi, JD, Pull, CB, Guelfi, C, Ruschel, S, Dreyfus, JF (1983) La CHESS. Utilisation dans la pathologie anxieuse et dépressive. Structure factorielle. Ann Méd Psychol 141, 257-278Google Scholar
Guelfi, JD, Boyer, P, Dreyfus, JF (1983) Placebo use in clinical trials on psychotropic drugs in France. Neuropsychobiology 9, 20-25CrossRefGoogle ScholarPubMed
Guelfi, JD, Barthelet, G, Lancrenon, S, Fermanian, J (1984) Structure factorielle de la HSCL sur un échantillon de patients anxio-dépressifs français. Ann Méd Psychol 142, 889-898Google Scholar
Guelfi, JD, Waintraub, L, Fermanian, J, Payan, C, Lemperière, T et al (1987) La version française de la CPRS. Analyse factorielle sur un échantillon de 208 patients. Psychiatr & Psychobiol 2, 395-444Google Scholar
Guelfi, JD (1988) Standardized clinical evaluation of depressive and anxious symptoinatology. Clin Neuropharmacol 11, (suppl) 2, S59-S68Google Scholar
Hamilton, M (1967) Development of a rating scale for primary depressive illness. Br J Soc Clin Psychol 6, 278-296CrossRefGoogle ScholarPubMed
Hardy, P, Jouvent, R, Lancrenon, S, Routnengous, V, Feline, A (1986) L’échelle de plaisir-déplaisir. Utilisation dans l’évaluation de la maladie dépressive. L'encéphale 12, 149-154Google Scholar
Hasin, D, Skodol, AE (1989) Standardized diagnostic interviews for psychiatrie research. In: The Instruments of Psychiatric Research. (Thompson, C, ed) John Wiley and Sons, ChichesterGoogle Scholar
Honigfeld, G (1974) Nosie-30. History and current status of its use in pharmacopsychiatric research. In: Psychological measurements in Psychopharmacology. Mod Probl Pharmacopsychiatry (Pichot P, ed) Karger, Basel 7, 238-263 Karger, BaselGoogle Scholar
Jouvent, R, Lecrubier, Y, Steru, L, Lancrenon, S, Widlocher, D (1981) Analyse multifactorielle de l’échelle de ralentissement psycho-moteur utilisée chez des déprimés ambulatoires. Psychol Méd 13, 97-107Google Scholar
Jouvent, R, Hardy, P, Bouvard, M, Braconnier, V, Roumengous, V, Grasset, F, Widlocher, D (1987) L’hétérogénéité de l’humeur dépressive. Construction d’une échelle polydimensionnelle. L ‘encépliale 13, 233-237Google Scholar
Lepine, JP, Godchau, M, Brun, P, Lemperière, Th (1985) Évaluation de l’anxiété et de la dépression chez des patients hospitalisés en service de médecine interne. Ann Méd Psychologiques 143, 175-189Google Scholar
Lingjaerde, O (1987) The UKU side effect rating scale. Acta Psychiatr Scand 76, (suppl) 334CrossRefGoogle Scholar
Lecrubier, Y, Steru, L, Lancrenon, S, Lavoisy, J (1983) Les déprimés ambulatoires en pratique de ville : une enquête épidémiologique. Actual Psychiatriques 2A, 19–26Google Scholar
Lorr, M, O’Connor, JP, Stafford, JW (1960) The Psychotic Reaction Profile. J Clin Psychol 16, 241-2453.0.CO;2-F>CrossRefGoogle ScholarPubMed
Montgomery, SA, Asberg, M (1979) A new depression scale designed to be sensitive to change. Br J Psychiatry 134, 382-389CrossRefGoogle ScholarPubMed
Overall, JE, Gorhant, DR (1962) The brief psychiatrie rating scale. Psychol Rep 10, 799-812CrossRefGoogle Scholar
Pariente, Ph, Lepine, JP, Boulenger, J-Ph, Zarifian, E, Lemperière, Th, Lellouch, J (1989) The symptom checklist 90 R (SCL 90-R) in a French general psychiatric 708 outpatient sample: is there a factorial structure? Psychiatr & Psychobiol 4, 151-157Google Scholar
Pellet, J, Bobon, D, Mormont, I, Lang, F, Massardier, A (1980) Étude princeps de validation française de la MADS, sous-échelle dépression de la CPRS. In: Comptes-rendus du congrès de psychiatrie et de neurologie de langue française, Masson, Paris, 297–301Google Scholar
Pellet, J, Decrat, M, Lang, F, Chazot, L, Tatu, P, Blanchon, Y, Berlier, JM (1987) Description d’un échantillon de 300 échelles MADRS portant sur des sujets déprimés. Ann Méd Psychologiques 145, 170-175Google Scholar
Pichot, P, Overall, JE, Samuel-Lajeunesse, B, Dreyfus, JF (1969) Structure factorielle de l’échelle abrégée d’appréciation psychiatrique (BPRS). Revue de Psychologie Appliquée 19, 218-232Google Scholar
Pichot, P, Brun, JP (1984) Questionnaire bref d’autoévaluation des dimensions dépressive, asthénique et anxieuse. Ann Méd Psychologiques 142, 862-865Google Scholar
Rafaelsen, OJ, Andersen, J, Bech, P (1983) Multi-axial classification of depression Multi-Clad-2: case record System. Acta Psychiatr Scand (suppl 310) 48, 85-102CrossRefGoogle Scholar
Roth, M, Gurney, C, Montjoy, CG (1983) The Newcastle Rating Scales. Acta Psychiatr Scand (suppl) 310, 42-54CrossRefGoogle ScholarPubMed
Spitzer, RL, Endicott, J, Robins, E (1978) Research diagnostic criteria: rationale and reliability. Arch Gen Psychiatry 35, 773-782CrossRefGoogle ScholarPubMed
Taylor, MA, Abrams, R (1978) The prevalence of schizophrenia: a reassessment using modern diagnostic criteria. Am J Psychiatry 135, 8, 945-948Google Scholar
Troisfontaines, B, Bobon, D (1987) Les échelles, analyses factorielles et sous-échelles de l’AMDP francophone. Acta Psychiatry Belg 87, 23-60Google Scholar
Van, Riezen H, Segal, M (1988) Comparative evaluation of rating scales for clinical psychopharmacology, Elsevier, AmsterdamGoogle Scholar
Von, Frenckell R, Bobon, D, Mormont, C, Pellet, J (1987) Le système AMDP. Description et Applications. Monographie Acta Psychiatr Belg vol 1, 2, 254 pGoogle Scholar
Weissman, MM (1977) Assessment of social Adjustment: measures suitable for antidepressant trials. In: Testing Drugs in Anxiety and Depression, US, FDA, RockvilleGoogle Scholar
Weissman, MM, Sholomskas, D, John, K (1981) The assessment of social adjustment: an update. Arch Gen Psychiatry 38, 1250-1258CrossRefGoogle ScholarPubMed
WHO (1977) Manual of the International Statistical Classification of Diseases, Injuries, and Causes of Death, 9th revision, vol 1, Geneva, WHOGoogle Scholar
WHO (1984) Guidelines for the Clinical In vestigation of Antidepressant Drugs, CopenhagenGoogle Scholar
WHO (1988) The Clinical Investigation of Antidepressant Drugs, Regional Office for Europe, CopenhagenGoogle Scholar
Widlocher, D (1981) L’échelle de ralentissement dépressif: fondements théoriques et premières applications. Psychol Méd 13B, 53–60Google Scholar
Wing, JK, Cooper, JE, Sartorius, N (1974) The Measurement and Classification of Psychiatric Symptoms: an Instruction Manual for the PSE and Catego System. Cambridge University Press, London. Traduction française par Timsit-Berthier M, Bragard-Ledent A, Mardaga, Bruxelles, 1980Google Scholar
Wittenborn, JR (1977) Guidelines for Clinical Trials of Psychotropie Drugs. Pharmakopsychiatry NeuroPsychopharmakol, 10, 205-231Google Scholar
World Psychiatric Association (1983) Diagnostic Criteria for Schizophrnic and Affective Psychoses 157-163Google Scholar
Zigmond, AS, Snaith, RP (1983) The hospital anxiety and depression scale. Acta Psychiatr Scand 67, 361-370CrossRefGoogle ScholarPubMed
Zung, WWK (1972) Depression status inventory: an adjunct to the self-rating depression scale. J Clin Psychol 28, 539-5433.0.CO;2-S>CrossRefGoogle ScholarPubMed
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