PMID- 19169187
OWN - NLM
STAT- MEDLINE
DCOM- 20090319
LR  - 20190923
IS  - 1092-8529 (Print)
IS  - 1092-8529 (Linking)
VI  - 14
IP  - 1
DP  - 2009 Jan
TI  - A placebo-controlled study evaluating the efficacy and safety of flexible-dose 
      desvenlafaxine treatment in outpatients with major depressive disorder.
PG  - 41-50
AB  - INTRODUCTION: This research compares the efficacy and safety of desvenlafaxine 
      (administered as desvenlafaxine succinate) versus placebo in treating major 
      depressive disorder. METHODS: In this randomized, double-blind study, outpatients 
      with major depressive disorder > or =18 years of age received desvenlafaxine 
      200-400 mg/day or placebo for 8 weeks. Efficacy endpoints included (primary) 
      change in 17-item Hamilton Rating Scale for Depression score at the final 
      evaluation (last observation carried forward, analysis of covariance) and 
      (secondary) Clinical Global Impressions-Improvement and -Severity of Illness 
      scales. RESULTS: The difference between desvenlafaxine (n==) and placebo (n==) on 
      the primary endpoint was not significant (-9.1 vs -7.5, P=.078). Week 8 observed 
      cases (desvenlafaxine, n=80; placebo, n=94) results were significant (-10.7 vs 
      -7.9, P=.008). Differences at the final evaluation (last observation carried 
      forward) were significant for Clinical Global Impressions-Improvement (2.9 vs 
      2.5, P=.037) and Clinical Global Impressions-Severity of Illness (-1.9 vs -1.2, 
      P=.041). Discontinuation rates due to adverse events (AEs) were 12% and 3% for 
      desvenlafaxine and placebo, respectively (P=.008). The most frequently reported 
      AE associated with desvenlafaxine was nausea (36% vs 9% [placebo]). CONCLUSION: 
      In this study, the primary analysis did not show significant differences between 
      desvenlafaxine and placebo; discontinuations due to AEs associated with the 
      desvenlafaxine dose range may have contributed to the lack of statistical 
      separation.
FAU - Feiger, Alan D
AU  - Feiger AD
AD  - Depression Center, University of Colorado, Aurora, CO, USA.
FAU - Tourian, Karen A
AU  - Tourian KA
FAU - Rosas, Gregory R
AU  - Rosas GR
FAU - Padmanabhan, S Krishna
AU  - Padmanabhan SK
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - CNS Spectr
JT  - CNS spectrums
JID - 9702877
RN  - 0 (Antidepressive Agents)
RN  - 0 (Cyclohexanols)
RN  - 0 (Placebos)
RN  - ZB22ENF0XR (Desvenlafaxine Succinate)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antidepressive Agents/adverse effects/therapeutic use
MH  - Cyclohexanols/adverse effects/*therapeutic use
MH  - Depressive Disorder, Major/*drug therapy
MH  - Desvenlafaxine Succinate
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Administration Schedule
MH  - Female
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Nausea/chemically induced
MH  - *Outpatients
MH  - Placebos
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2009/01/27 09:00
MHDA- 2009/03/20 09:00
CRDT- 2009/01/27 09:00
PHST- 2009/01/27 09:00 [entrez]
PHST- 2009/01/27 09:00 [pubmed]
PHST- 2009/03/20 09:00 [medline]
AID - 10.1017/s1092852900020046 [doi]
PST - ppublish
SO  - CNS Spectr. 2009 Jan;14(1):41-50. doi: 10.1017/s1092852900020046.