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Patient sampling in anxiety studies: factors influencing response rate

Published online by Cambridge University Press:  16 April 2020

W Rein  and
PL Morselli
W Rein
Affiliation:
Synthelabo Recherche, 31, avenue Paul Vaillant-Couturier, BP 110, F92225Bagneux, France
PL Morselli
Affiliation:
Synthelabo Recherche, 31, avenue Paul Vaillant-Couturier, BP 110, F92225Bagneux, France
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Extract

Today it appears that a general consensus exists concerning the methodological principles to be used in establishing the efficacy profile of a new drug in anxiety disorders, ie a double-blind, parallel group design testing different doses of the new drug versus placebo (Angst et al, 1993; Rickels, 1990), however there is also growing concern about increasingly high placebo response rates and important differences between countries in these trials. This seems to be true despite the fact that in recent years, selection criteria for diagnosis and severity of the disorders have become more clearly defined and more restrictive than in the past.

This situation increases the risk of false negative results in otherwise well designed clinical trials with new anxiolytic drugs and can incite pharmaceutical companies to abandon the further development of efficacious compounds even if they have potential advantages in terms of safety over the available products.

Type
Research Article
Information
European Psychiatry , Volume 9 , Issue 3: European Committee for Standardisation of Clinical Trials with Psychotropics, ECST Strasbourg Forum III. 10-11 June 1993, Strasbourg, France , 1994 , pp. 137 - 139
Copyright
Copyright © Elsevier, Paris 1994

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References

Angst, JAnsseau, MBech, Ρet al.Report on the fourth consensus conference on the methodology of clinical trials with anxiolytic drugs. Pharmacopsychiatry 1993:26:1–5CrossRefGoogle ScholarPubMed
Heimann, HRein, WRater Training for the Use of Psychiatric Rating scales. In: Bobon, Det al, eds, AMDP-System in Pharmacopsychiatry. Mod probl Pharmacopsychiatry Vol 20. Basel: Karger, 1983;119–24Google Scholar
Rickels, KEvaluating Antidepressants and Anxiolytics. In: Benkert, OMaier, Wand Rickels, K eds. Methodology of the Evaluation of Psychotropic Drugs. Berlin: Springer, 1990;3–25CrossRefGoogle Scholar
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