The antidepressant efficacy and safety of desvenlafaxine succinate (desvenlafaxine) were evaluated in a phase III, double-blind, placebo-controlled study. Outpatients with a primary diagnosis of major depressive disorder were treated with fixed once-daily doses of desvenlafaxine 200 or 400 mg for 8 weeks. The primary efficacy measure was change from baseline on the 17-item Hamilton Rating Scale for Depression. At the final on-therapy evaluation, adjusted mean change from baseline in 17-item Hamilton Rating Scale for Depression total score was greater for desvenlafaxine 200 and 400 mg/day vs. placebo. Both desvenlafaxine doses showed greater efficacy than placebo on the secondary efficacy measures, including the Clinical Global Impressions-Improvement scale scores, Montgomery-Asberg Depression Rating Scale scores, CGI-Severity, and 17-item Hamilton Rating Scale for Depression response rate. Desvenlafaxine 200 mg/day was also significantly better than placebo on remission, Visual Analog Scale-Pain Intensity overall scores, and some Visual Analog Scale-Pain Intensity subscale scores. Desvenlafaxine 400 mg/day was significantly better than placebo on selected Visual Analog Scale-Pain Intensity subscale scores. Most adverse events were mild or moderate in severity, and safety assessments revealed few clinically significant changes in vital signs, laboratory tests, and electrocardiogram results. These data provide support for the efficacy and safety of desvenlafaxine in the treatment of major depressive disorder.
Objective:To evaluate functioning, well being, and pain outcomes with desvenlafaxine succinate (DVS) treatment in depressed men and women of different age groups.Methods:Data from the Sheehan Disability Scale (SDS), 5-item World Health Organization Well-Being Index (WHO-5), and Visual Analog Scale–Pain Intensity (VAS-PI) were pooled from 6 double-blind, placebo-controlled, 8-week DVS trials conducted in outpatients with major depressive disorder (MDD). Patients were divided into 3 age groups. The 18-39 and >55 years of age groups were chosen as proxies for pre- and postmenopausal status; the age group of 40-55 years, which was likely to include perimenopausal women, was also evaluated. Male patients were similarly grouped to differentiate effects of menopausal status from age on treatment response.Results:Patients were randomized to receive DVS 100-400mg (N=1048; 18-39 years [n=451]; 40-55 years [n=457]; >55 [n=140]) or placebo (N=718; 18-39 years [n=306]; 40-55 years [n=310]; >55 [n=102]). The final SDS, WHO-5, and VAS-PI overall pain change from baseline for the total population were significantly greater in the DVS vs the placebo group (P<0.001). Mean differences (adjusted ANCOVA) from placebo in women were: SDS: 18-39: –2.1, 40-55: –2.1, >55: –3.2; WHO-5: 18-39: +1.1, 40-55: +1.8, >55: +3.3; VAS-PI 18-39: –1.4, 40-55: –5.2, >55: –9.1. In men, results were consistent across age groups studied (SDS: 18-39: –2.9, 40-55: –3.4, >55: +2.6; WHO-5: 18-39: +1.5, 40-55: +2.4, >55: –0.3; VAS-PI 18-39: –3.0, 40-55: –7.7, >55: +2.0).Conclusions:DVS improves functional outcomes and pain symptoms in depressed men and women across the age groups studied.
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