The objective of this study was to explore the relationship between assessments of functional impairment, emotional well-being, and depression symptoms. Data were pooled from 3530 outpatients with major depressive disorder enrolled in 10 desvenlafaxine clinical trials. The primary outcome measures included (a) the 17-item Hamilton Rating Scale for Depression (HAM-D17) as a measure of depressive symptom severity and (b) the Sheehan Disability Scale (SDS) and five-item World Health Organization Well-Being Index (WHO-5) as measures of functional impairment and well-being. A linear regression model was used to identify the SDS and WHO-5 values that equate to the predetermined clinically relevant three-point difference between active treatment and placebo on the HAM-D17. A receiver operating characteristic analysis was conducted to determine the SDS score that equates to a remission of depression symptoms (i.e. HAM-D17 ≤7). An approximate three-point difference between active treatment and placebo on the SDS (2.8) and WHO-5 (2.5) was determined to be clinically relevant in relation to improvements in depressive symptoms. An SDS of less than or equal to 7 was equivalent to a remission of depression symptoms, providing a definition of functional remission. A better understanding of the relationship between depressive symptoms and functional impairment and well-being may provide clinicians with a more comprehensive means of assessing treatment effects in major depressive disorder.
aPfizer Inc., Collegeville, Pennsylvania, USA
bMcMaster University, Ontario, Canada
Previous Presentation: data in this manuscript were presented at the International Society for Affective Disorders 5th Biennial Congress, April 16–19, 2010, Vancouver, Canada; the Royal Australian and New Zealand College of Psychiatrists Annual Meeting, May 2–6, 2010, Auckland, New Zealand; and the American Academy of Nurse Practitioners Annual Meeting, June 23–27, 2010, Phoenix, Arizona, USA.
All supplementary data are available directly from the authors.
Correspondence to Christine J. Guico-Pabia, MD, MPH, MBA, Senior Director, Medical Affairs – Primary Care Business Unit, Pfizer Inc., 500 Arcola Road, Collegeville, PA 19426, USA Tel: +484 865 6520; fax: +484 865 4278; e-mail: email@example.com
Received January 28, 2011
Accepted August 19, 2011