Efficacy and safety of desvenlafaxine 50 mg/d in a randomized, placebo-controlled study of perimenopausal and postmenopausal women with major depressive disorder.
OBJECTIVE
Evaluate the 8-week efficacy and safety of desvenlafaxine at the recommended dose of 50 mg/d in perimenopausal and postmenopausal women with major depressive disorder (MDD) based on the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision.


METHODS
This phase 4, multicenter, parallel-group, randomized, double-blind, placebo-controlled study was conducted from June 30, 2010, to June 8, 2011. Patients received placebo or desvenlafaxine 50 mg/d (1:1 ratio; n = 217 in each group). The primary outcome measure was the change at week 8 in the 17-item Hamilton Depression Rating Scale (HDRS17) total score. Secondary outcome measures included change in the Sheehan Disability Scale (SDS), the Clinical Global Impressions-Improvement scale (CGI-I), the Montgomery-Asberg Depression Rating Scale (MADRS), and the Visual Analog Scale-Pain Intensity (VAS-PI).


RESULTS
At end point, compared to placebo, desvenlafaxine was associated with a significantly greater decrease in HDRS17 total scores (last-observation-carried-forward analysis; adjusted mean change from baseline -9.9 vs -8.1, respectively; P = .004) and significant improvements on the CGI-I (P < .001), MADRS (P = .002), SDS (P = .038), and VAS-PI (P < .001). Improvements on the SDS and VAS-PI reached significance by week 2. Desvenlafaxine was generally safe and well tolerated.


CONCLUSIONS
Short-term treatment with desvenlafaxine 50 mg/d was effective for the treatment of MDD in perimenopausal and postmenopausal women, with significant benefits on pain and functional outcomes evident as early as week 2. The safety and tolerability of desvenlafaxine were consistent with data in other populations.


BACKGROUND
ClinicalTrials.gov identifier: NCT01121484.
Psychiatry and Neurobehavioral Sciences, University of Virginia, 2955 Ivy Rd, Northridge Ste 210, Charlottesville, VA 22903 ahc8v@virginia.edu.
Anita H
AH
Clayton
Susan G
SG
Kornstein
Boadie W
BW
Dunlop
Kristen
K
Focht
Jeff
J
Musgnung
Tanya
T
Ramey
Weihang
W
Bao
Philip T
PT
Ninan
D000328:Adult; D000368:Aged; D000928:Antidepressive Agents / Q000008:administration & dosage / Q000009:adverse effects; D003511:Cyclohexanols / Q000008:administration & dosage / Q000009:adverse effects; D003865:Major Depressive Disorder / Q000175:diagnosis / Q000188:drug therapy / Q000209:etiology; D000069468:Desvenlafaxine Succinate; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D008593:Menopause / Q000523:psychology*; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D016896:Treatment Outcome
D000928:Antidepressive Agents; D003511:Cyclohexanols; D000069468:Desvenlafaxine Succinate