To assess the efficacy of desvenlafaxine succinate (DVS) treatment in patients with major depressive disorder (MDD).

Seven randomized, double-blind, placebo-controlled, short-term studies were pooled to evaluate the efficacy of DVS in MDD. Adult outpatients with DSM-IV MDD were enrolled in all studies. Eligible patients were randomly assigned to DVS (n=1186) at doses of 100–400 mg/d, or placebo (n=797) for 8 weeks. The 17-item Hamilton Depression Rating Scale (HAM-D17) was the primary efficacy variable. Other efficacy variables were the Clinical Global Impressions scale (CGI), HAM-D6, Montgomery Åsberg Depression Rating Scale (MADRS), Covi Anxiety scale, Sheehan Disability Scale (SDS), WHO-5 Well-Being Index, and the Visual Analog Scale–Pain Intensity (VAS-PI). A mixed-effect model for repeated measures (MMRM) analysis was used to analyze continuous variables. Logistic regression was used to analyze response and remission rates.

An adjusted mean difference of –2.8 points on HAM-D17 total score at end point for DVS vs placebo (95% confidence limits: –2.2, –3.4; P<0.001) was demonstrated. Response and remission rates were significantly elevated for DVS-treated patients compared with placebo (P<0.001) across rating scales (HAM-D17, MADRS, and CGI). For other secondary measures at end point, including the CGI, HAM-D6, MADRS, Covi, SDS, WHO-5, and VAS-PI, significant differences from placebo were also observed. No additional benefit was observed for DVS doses above 100 mg/d in analyses of fixed-dose studies.

DVS was efficacious in treating MDD based on standard depression rating scales and measures of anxiety, global severity/improvement, functioning, well being, and pain.