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

Claudio N. Soares, MD, PhD, FRCPC; Susan G. Kornstein, MD; Michael E. Thase, MD; Qin Jiang, MS; Christine J. Guico-Pabia, MD

J Clin Psychiatry 2009;70(10):1365-1371

Article Abstract

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 protected]).