Article

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

Department of Psychiatry and Behavioural Neurosciences, Mood Disorders Division, McMaster University, Hamilton, Ontario, L8P 3B6, Canada.
The Journal of Clinical Psychiatry (Impact Factor: 5.14). 10/2009; 70(10):1365-71. DOI: 10.4088/JCP.09m05133blu
Source: PubMed

ABSTRACT To evaluate the effects of desvenlafaxine therapy on functioning and well-being in major depressive disorder (MDD).
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 (HDRS(17)) 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.
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 HDRS(17) 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.
Desvenlafaxine therapy resulted in significant improvements in the functioning and well-being among MDD patients.

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    • "Despite recent focus on assessing functional impairment as an important ‘real-world’ outcome of antidepressant treatment (Zimmerman et al., 2006; Sheehan and Sheehan, 2008; Soares et al., 2009; Langlieb and Guico-Pabia, 2010; Sheehan et al., 2011; Mancini et al., 2012), there have been relatively few studies examining whether there are baseline characteristics that predict the likelihood of improved functional impairment during treatment. One recent post-hoc analysis of a large pool of data from studies on the SNRI duloxetine versus placebo reported that female sex, a shorter time since the first depressive episode, absence of previous antidepressant use, and mild versus more severe pain were all prognostic factors for improved functioning following antidepressant treatment (Mancini et al., 2012). "
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