Efficacy and safety of desvenlafaxine 50 mg/d in a randomized, placebo-controlled
study of perimenopausal and postmenopausal women with major depressive disorder.
Author(s): Clayton AH(1), Kornstein SG, Dunlop BW, Focht K, Musgnung J, Ramey T, Bao W,
Ninan PT.
Affiliation(s): Author information:
(1)Psychiatry and Neurobehavioral Sciences, University of Virginia, 2955 Ivy Rd,
Northridge Ste 210, Charlottesville, VA 22903 ahc8v@virginia.edu.
Publication date & source: 2013, J Clin Psychiatry. , 74(10):1010-7
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.
METHOD: 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.
TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT01121484.
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