Placebo run-in period in studies of depressive disorders

British Journal of Psychiatry - Tập 173 Số 3 - Trang 242-248 - 1998
F M Quitkin1, Patrick J. McGrath1, J W Stewart1, Katja Ocepek‐Welikson1, Bonnie P. Taylor1, Edward V. Nunes1, Deborah Delivannides1, Vito Agosti1, Steven Donovan1, Donald C. Ross1, Eva Petkova1, Donald F. Klein1
1Department of Therapeutics, Columbia University College of Physicians and Surgeons, New York State Psychiatric Institution, New York, USA

Tóm tắt

BackgroundIn 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.MethodData 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.ResultsTwenty-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.ConclusionsChange during IPR appears to be a meaningful predictor. Stratification should be considered in future antidepressant studies.

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Thông tin xuất bản

British Journal of Psychiatry

Tập 173 Số 3

242-248

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