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Title: Impact of geographical and cultural factors on clinical trials in acute mania: lessons from a ziprasidone and haloperidol placebo-controlled study
Author: Vieta i Pascual, Eduard, 1963-
Pappadopulos, E.
Mandel, F.S.
Lombardo, I.
Keywords: Trastorn bipolar
Assaigs clínics
Manic-depressive illness
Antipsychotic drugs
Clinical trials
Issue Date: 14-Mar-2011
Publisher: Cambridge University Press
Abstract: Clinical trials today are conducted in multiple countries to enhance patient recruitment and improve efficiency of trials. However, the demographic and cultural diversity may contribute to variations in study outcomes. Here we conducted post-hoc analyses for a placebo-controlled study with ziprasidone and haloperidol for the treatment of acute mania to address the demographic, dosing, and outcome disparities in India, Russia and the USA. We compared the baseline characteristics, outcomes and discontinuations in patients and explored the relationship between the outcome measures across these countries. We found substantial differences in baseline characteristics of subjects, administered dosage and disease severity in India compared to the USA and Russia. Conversely, US subjects had a higher placebo response compared to subjects in Russia and India. These results are probably due to demographic differences in patient populations and psychiatric clinical practice across countries. While we offer initial ideas to address the disparities identified in this analysis, it is clear that further research to improve our understanding of geographical differences is essential to ensure globally applicable results for clinical trials in psychiatry.
Note: Reproducció del document publicat a:
It is part of: International Journal of Neuropsychopharmacology, 2011, vol. 14, num. 8, p. 1017-1027
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ISSN: 1461-1457
Appears in Collections:Articles publicats en revistes (Psicologia Clínica i Psicobiologia)

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