Abstract
Over the past few decades, a number of clinician-rated and patient-rated instruments have been developed as primary efficacy measures in depression clinical trials. All those scales have relative strengths and weaknesses and some of them have been more successful than others, and have become the gold standards for depression clinical research. With all these measures available and with the evidence of their variable performance in clinical trials, it is becoming increasingly important to select primary efficacy measures that are reliable, valid, and that fit well within the aims of depression clinical trials. This article will review the main considerations that investigators need to make when choosing a primary efficacy measure for major depressive disorder (MDD). There is a clear need for a thorough discussion of the methodological issues concerning the use of these scales, as suggested also by Demyttenaere and De Fruyt in a recent review [1], because clinical trials researchers in depression continue to struggle with the ability to detect signals of the efficacy of antidepressant agents.
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Acknowledgments
This work has been funded in whole or in part with Federal funds from the National Institute of Mental Health, National Institutes of Health, under Contract N01MH90003 (STAR*D) and GMO N01MH90003 (NIMH Depression Trials Network). The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. Government.
The authors thank Dr Janet B.W. Williams, Dr Kenneth Kobak, and Dr John Rush for their contributions to this chapter.
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Cusin, C., Yang, H., Yeung, A., Fava, M. (2009). Rating Scales for Depression. In: Baer, L., Blais, M.A. (eds) Handbook of Clinical Rating Scales and Assessment in Psychiatry and Mental Health. Current Clinical Psychiatry. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-59745-387-5_2
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