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Placebo run-in period in studies of depressive disorders

Clinical, heuristic and research implications

Published online by Cambridge University Press:  03 January 2018

Frederic M. Quitkin ,
Patrick J. McGrath ,
Jonathan W. Stewart ,
Katja Ocepek-Welikson ,
Bonnie P. Taylor ,
Edward Nunes ,
Deborah Delivannides ,
Vito Agosti ,
Steven J. Donovan  and
Donald Ross
...Show all authors
Frederic M. Quitkin
Affiliation:
Department of Therapeutics, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institution, New York, USA
Patrick J. McGrath
Affiliation:
Department of Therapeutics, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institution, New York, USA
Jonathan W. Stewart
Affiliation:
Department of Therapeutics, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institution, New York, USA
Katja Ocepek-Welikson
Affiliation:
Department of Therapeutics, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institution, New York, USA
Bonnie P. Taylor
Affiliation:
Department of Therapeutics, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institution, New York, USA
Edward Nunes
Affiliation:
Department of Therapeutics, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institution, New York, USA
Deborah Delivannides
Affiliation:
Department of Therapeutics, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institution, New York, USA
Vito Agosti
Affiliation:
Department of Therapeutics, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institution, New York, USA
Steven J. Donovan
Affiliation:
Department of Therapeutics, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institution, New York, USA
Donald Ross
Affiliation:
Department of Therapeutics, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institution, New York, USA
Eva Petkova
Affiliation:
Department of Therapeutics, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institution, New York, USA
Donald F. Klein
Affiliation:
Department of Therapeutics, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institution, New York, USA
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Abstract

Background

In spite of the virtually ubiquitous nature of the initial 10-day placebo run-in period (IPR) in drug trials, there is little empirical data establishing its relevance.

Method

Data from 593 subjects were examined retrospectively to determine whether or not the prognosis of subjects minimally improved during the IPR was different to those who were unimproved. The IPR period was single-blind and was followed by a six-week double-blind phase in all studies.

Results

Twenty-six per cent of the subjects were minimally improved and 74% were unimproved. Approximately 10% of the subjects who were much improved were not followed systematically. Across a range of diagnosis, severity and chronicity subjects minimally improved (versus unimproved) after IPR had a more favourable prognosis whether assigned to drug or placebo.

Conclusions

Change during IPR appears to be a meaningful predictor. Stratification should be considered in future antidepressant studies.

Type
Papers
Information
The British Journal of Psychiatry , Volume 173 , Issue 3 , September 1998 , pp. 242 - 248
Copyright
Copyright © 1998 The Royal College of Psychiatrists 

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