Document Type
Journal Article
Study Type
Randomized Controlled Trial
Publication Date
7-2008
Journal
International clinical psychopharmacology
Volume
23
Issue
4
Inclusive Pages
188-97
DOI
10.1097/YIC.0b013e32830263de
Keywords
Adrenergic Uptake Inhibitors; Antidepressive Agents; Cyclohexanols; Depressive Disorder, Major; Desvenlafaxine Succinate; Humans; Randomized Controlled Trials as Topic; Serotonin Uptake Inhibitors
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
APA Citation
Lieberman, D., Montgomery, S., Tourian, K., Brisard, C., Rosas, G., Padmanabhan, K., Germain, J., & Pitrosky, B. (2008). A pooled analysis of two placebo-controlled trials of desvenlafaxine in major depressive disorder.. International clinical psychopharmacology, 23 (4). http://dx.doi.org/10.1097/YIC.0b013e32830263de
Peer Reviewed
1
