Assessing the Efficacy of Desvenlafaxine for Improving Functioning and Well-Being Outcome Measures in Patients With Major Depressive Disorder: A Pooled Analysis of 9 Double-Blind, Placebo-Controlled, 8-Week Clinical Trials
J Clin Psychiatry 2009;70(10):1365-1371
© Copyright 2014 Physicians Postgraduate Press, Inc.
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Objective: To evaluate the effects of desvenlafaxine therapy on functioning and well-being in major depressive disorder (MDD).
Method: Total and individual item Sheehan Disability Scale (SDS) and 5-item World Health Organization Well-Being Index (WHO-5) scores from 8 double-blind, placebo-controlled, 8-week desvenlafaxine clinical trials were pooled. Scores on the 17-item Hamilton Depression Rating Scale (HDRS17) work/activities and Montgomery-Asberg Depression Rating Scale (MADRS) lassitude items were pooled from 9 studies. Outpatients with DSM-IV MDD were randomly assigned to fixed(5 studies; 50, 100, 200, or 400 mg/d; n = 1,342)or flexible (4 studies, 100–400 mg/d; n = 463) doses of desvenlafaxine or placebo (n = 1,108). Data from each patient’s final evaluation were analyzed for the total population and for individual dose groups from the fixed-dose studies and were compared between groups using analysis of covariance.
Results: Compared with placebo, desvenlafaxine therapy resulted in significantly greater improvements in SDS total score (–2.0) and individual items regarding work (–0.6), social life/leisure activities (–0.8), and family life/home responsibilities (–0.7; P < .001 for all comparisons), as well as WHO-5 total score (1.7) and individual items (good spirits [0.4], calm/relaxed [0.4],
active/vigorous [0.3], fresh/rested [0.3], and
interest [0.3]; P < .001 for all comparisons).
Desvenlafaxine treatment resulted in significant improvements on the HDRS17 work/activities
(–0.2; P < .001) and MADRS lassitude (–0.3; P < .001) items compared with placebo. Significant differences were observed for the individual fixed-dose groups on all outcomes (P < .05); there was
no evidence of a dose-response relationship.
Conclusions: Desvenlafaxine therapy resulted in significant improvements in the functioning and well-being among MDD patients.
Submitted: February 13, 2009; accepted July 10, 2009.
Corresponding author: Claudio N. Soares, MD, Department of Psychiatry and Behavioural Neurosciences, Mood Disorders Division, McMaster University, 301 James St South, FB 638, Hamilton, Ontario, L8P 3B6, Canada (email@example.com).