Evaluation of the Efficacy and Safety of Desvenlafaxine 50 and 100 mg/d in Patients With Major Depressive Disorder: Results From 2 Placebo-Controlled Studies

  • Jim Meaney, Wyeth Research, Collegeville, Pennsylvania, United States
  • Dr Michael Liebowitz, Columbia University, New York, New York, United States
  • Dr Stuart Montgomery, Imperial College School of Medicine, London, England, United Kingdom
  • Dr Patrice Boyer, University of Ottawa, Ontario, Canada, Canada
  • Amy Manley, Wyeth Research, Collegeville, Pennsylvania, United States
  • Sudharshan Padmanabhan, Wyeth Research, Collegeville, Pennsylvania, United States
  • Dr Jean-Michel Germain, Wyeth Research, Paris, France, France
  • Dr Karen Tourian, Wyeth Research, Collegeville, Pennsylvania

    • Objective: To assess the efficacy and safety of 50- and 100-mg/d doses of the serotonin-norepinephrine reuptake inhibitor (SNRI) desvenlafaxine (administered as desvenlafaxine succinate) in the treatment of major depressive disorder (MDD).
    Methods: Two identically designed, randomized, double-blind, placebo-controlled studies were conducted. One study took place in the United States (US) and the other was international (INT; European Union and South Africa). Participants had Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition MDD, with a 17-item Hamilton Rating Scale for Depression (HAM-D17) total score ≥20 at screening and baseline. Patients were randomly assigned to treatment groups, which included desvenlafaxine 50 mg/d, desvenlafaxine 100 mg/d, or placebo. Treatment was administered for 8 weeks (including a 1-week, 50-mg/d titration period for the 100-mg/d group). The primary efficacy variable was change from baseline on the HAM-D17 at the final on-therapy evaluation.
    Results: In the US study (n=483), compared with placebo, a significant difference was observed in the adjusted mean change from baseline on the HAM-D17 in the 50-mg/d group (–11.5 vs –9.5; P<0.05), although no significant difference was observed in the 100-mg/d group. In the INT study (n=447), there was a significantly greater improvement on this same measure for both desvenlafaxine groups (50 mg: –13.2; P=0.002; 100 mg:
    –13.7; P<0.001) compared with placebo (–10.7). Each dose of desvenlafaxine was generally well tolerated and adverse events were consistent with the SNRI class.
    Conclusions: These results demonstrate the efficacy of desvenlafaxine 50 and 100 mg/d in the treatment of MDD.