The Effect of Vortioxetine on Overall Patient Functioning in Patients with Major Depressive Disorder
Document Type
Article
Publication Date
2017
Keywords
functional impairment, major depressive disorder, quality of life Sheehan Disability Scale, vortioxetine
Digital Object Identifier (DOI)
https://doi.org/10.1002/brb3.622
Abstract
Background: The objectives of this meta-analysis of data from randomized, placebo-controlled studies were to assess the effect of vortioxetine on overall functioning (primary) and functional remission (secondary) using the Sheehan Disability Scale (SDS) in adults with major depressive disorder (MDD).
Methods: Data from nine short-term (6/8 weeks) pivotal studies that included patient functioning assessments were included in this random-effects meta-analysis, which used aggregated study-level data for all therapeutic vortioxetine doses and a mixed-effect model for repeated measures using the full analysis set.
Results: A total of 4,216 patients received ≥1 dose of study treatment (1,522 placebo, 2,694 vortioxetine 5–20 mg/day). At study end, the meta-analysis showed improvement for vortioxetine versus placebo (n = 911) in SDS total score (vortioxetine 5 mg, n = 564, change from baseline versus placebo [Δ] −0.24, p = NS; 10 mg, n = 445, Δ −1.68, p ≤ .001; 15 mg, n = 204, Δ −0.91, p = NS; 20 mg, n = 340, Δ −1.94, p ≤ .01). Functional remission (SDS total score ≤6) was observed with vortioxetine 10 mg (n = 170/573; odds ratio [OR] relative to placebo 1.7, p < .001) and 20 mg (n = 144/447; OR 1.6, p < .05), but not 5 mg (n = 207/757; OR 1.1, p = NS) or 15 mg (n = 92/295; OR 1.3, p = NS).
Conclusion: Vortioxetine 5–20 mg for 6/8 weeks improved overall patient functioning in patients with MDD. Relative to placebo, vortioxetine 10 and 20 mg demonstrated significant improvement in SDS total score and functional remission.
Rights Information
This work is licensed under a Creative Commons Attribution 4.0 License.
Was this content written or created while at USF?
Yes
Citation / Publisher Attribution
Brain and Behavior, v. 7, issue 3, art. e00622
Scholar Commons Citation
Florea, Ioana; Loft, Henrik; Danchenko, Natalya; Rive, Benoît; Brignone, Melanie; Merikle, Elizabeth; Jacobsen, Paula L.; and Sheehan, David V., "The Effect of Vortioxetine on Overall Patient Functioning in Patients with Major Depressive Disorder" (2017). Internal Medicine Faculty Publications. 157.
https://digitalcommons.usf.edu/intmed_facpub/157
