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What are the reciprocal influences of randomized clinical trials and the patient–psychiatrist relationship?

Published online by Cambridge University Press:  16 April 2020

J. Catteau
Affiliation:
REPP (Réseau d'Expérimentation en Psycho-Pharmacologie), Service de Pharmacologie, CHRU de Lille, 2 avenue Oscar-Lambret, 59045Lille cedex, France
C. Cyran
Affiliation:
REPP (Réseau d'Expérimentation en Psycho-Pharmacologie), Service de Pharmacologie, CHRU de Lille, 2 avenue Oscar-Lambret, 59045Lille cedex, France
R. Bordet
Affiliation:
REPP (Réseau d'Expérimentation en Psycho-Pharmacologie), Service de Pharmacologie, CHRU de Lille, 2 avenue Oscar-Lambret, 59045Lille cedex, France
C.E. Thomas
Affiliation:
REPP (Réseau d'Expérimentation en Psycho-Pharmacologie), Service de Pharmacologie, CHRU de Lille, 2 avenue Oscar-Lambret, 59045Lille cedex, France
B.A. Dupuis
Affiliation:
REPP (Réseau d'Expérimentation en Psycho-Pharmacologie), Service de Pharmacologie, CHRU de Lille, 2 avenue Oscar-Lambret, 59045Lille cedex, France
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Summary

The goal of this prospective investigation was to study the course and the quality of patient-psychiatrist relationships during phase II / phase III clinical trials of antidepressant medication prescribed for depressive disorders. All patients who participated in the clinical trials (and subsequently in this survey) signed written informed consent statements and were subject to random double blind treatment assignment. Retrospective analysis of 118 investigations was carried out, and the patients involved were questioned concerning their experiences and impressions during and after the study. Data show that the outcome of clinical trials of antidepressant drugs are not a function of pre-existing good patient-psychiatrist relationships. On the other hand, no effects on the patient-psychiatrist relationship were found as a result of the experimental procedure, and it can be concluded that no detrimental effects on future patient-psychiatrist relationships were incurred.

Type
Original articles
Copyright
Copyright © Elsevier, Paris 1999

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References

Appelbaum, P. Competency to consent to research: a psychiatric overview. Arch Gen Psychiatry 1982 ; 39 : 951951.CrossRefGoogle ScholarPubMed
Appelbaum, P. Rethinking the conduct of psychiatric research. Arch Gen Psychiatry 1997 ; 54 : 117120.10.1001/archpsyc.1997.01830140025004CrossRefGoogle ScholarPubMed
Bordet, RThomas, PDupuis, B. Effet of pindolol on onset of action of paroxetine in the treatment of major depression: intermediate analysis of a double-blind, placebo-controlled trial. Am J Psychiatry 1998 ; 155 : 13461351.CrossRefGoogle Scholar
Dawes, PDavison, P. Informed consent: what do patients want to know? J R Soc Med 1994 ; 87 : 149152.Google ScholarPubMed
Kerrigan, DThevasagayam, RSWoods, TOMcWelch, IThomas, WEShorthouse, AJet alWho's afraid of informed consent? Br Med J 1993 ; 306 : 298300.CrossRefGoogle ScholarPubMed
Lachaux, BMalauzat, D. Entre consentement aux soins et assentiment aux expérimentations. Psychol Méd 26, spécial 7 : 638 1994 646.Google Scholar
Lachaux, B. Nouveaux enjeux légaux et réglementaires de l'expérimentation clinique. Synapse 1995 ; 120 : 3543.Google Scholar
Lavelle-Jones, CByrne, DJRice, PCuschieri, A. Factors affecting quality of informed consent. Br Med J 1993 ; 306 : 885890.CrossRefGoogle ScholarPubMed
Lynöe, NSandlund, MDahlquist, GJacobson, L. Informed consent: study of quality of information given to participants in a clinical trial. Br Med J 1991 ; 303 : 610613.CrossRefGoogle ScholarPubMed
Saw, CWood, AMurphy, KParry, JHartfall, G. Informed consent: an evaluation of patients'understanding and opinion J R Soc Med 1994 ; 87 : 143144.Google Scholar
Silverman, W. The myth of informed consent: in daily practice and in clinical trials. J Med Ethics 1989 ; 15 : 611.CrossRefGoogle ScholarPubMed
Wager, ETooley, PJEmanuel, MBWood, SF. Get patients' consent to enter clinical trials. Br Med J 1995 ; 311 : 734737.CrossRefGoogle ScholarPubMed
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