A pooled analysis of two placebo-controlled trials of desvenlafaxine in major depressive disorder

Int Clin Psychopharmacol. 2008 Jul;23(4):188-97. doi: 10.1097/YIC.0b013e32830263de.

Abstract

The efficacy, safety, and tolerability of desvenlafaxine (administered as desvenlafaxine succinate) were evaluated in two similarly designed, phase 3, randomized, double-blind, placebo-controlled, venlafaxine-extended-release-referenced, flexible-dose studies of outpatients with a primary diagnosis of major depressive disorder. Owing to a high placebo response, the individual studies were underpowered. Therefore, a post-hoc pooled analysis was performed (desvenlafaxine and placebo data were pooled; venlafaxine extended release data were not, owing to different flexible-dose regimens in the two studies). The primary outcome measure was the change from baseline on the 17-item Hamilton Rating Scale for Depression; the Clinical Global Impressions-Improvement item score was a secondary outcome. Analysis of the pooled data (using a mixed-effect model for repeated measures) revealed that after 8 weeks of treatment, desvenlafaxine was significantly better than placebo on 17-item Hamilton Rating Scale for Depression [-14.21 vs. -11.87 for desvenlafaxine and placebo, respectively; magnitude of effect=-2.34 (P<0.001)] and Clinical Global Impressions-Improvement item scores [1.95 vs. 2.32 for desvenlafaxine and placebo, respectively; magnitude of effect=-0.37 (P<0.001)]. Adverse events were comparable to those found with other drugs sharing a similar mechanism of action. These data support the efficacy, safety, and tolerability of desvenlafaxine in the treatment of major depressive disorder.

Publication types

  • Meta-Analysis

MeSH terms

  • Adrenergic Uptake Inhibitors / adverse effects
  • Adrenergic Uptake Inhibitors / therapeutic use*
  • Antidepressive Agents / adverse effects
  • Antidepressive Agents / therapeutic use*
  • Cyclohexanols / adverse effects
  • Cyclohexanols / therapeutic use*
  • Depressive Disorder, Major / drug therapy*
  • Desvenlafaxine Succinate
  • Humans
  • Randomized Controlled Trials as Topic
  • Serotonin Uptake Inhibitors / adverse effects
  • Serotonin Uptake Inhibitors / therapeutic use*

Substances

  • Adrenergic Uptake Inhibitors
  • Antidepressive Agents
  • Cyclohexanols
  • Serotonin Uptake Inhibitors
  • Desvenlafaxine Succinate