Vortioxetine improves symptomatic and functional outcomes in major depressive disorder: a novel dual outcome measure in depressive disorders
Summary. With symptomatic remission and functional recovery as the overarching therapeutic objectives of antidepressant therapy, composite endpoint measures that conjointly consider both aspects of treatment are needed. This analysis evaluated the combined effect of vortioxetine on depressive symptom...
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| Format: | Article |
| Language: | Russian |
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Federal State Budget Scientific Institution National Medical Research Center for Psychiatry and Neurology n.a. V.M. Bekhterev Ministry of Health of the Russian Federation
2019-07-01
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| Series: | Обозрение психиатрии и медицинской психологии имени В.М. Бехтерева |
| Online Access: | https://www.bekhterevreview.com/jour/article/view/250 |
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| author | М. С. Christensen Н. Loft R. S. McIntyre |
| author_facet | М. С. Christensen Н. Loft R. S. McIntyre |
| author_sort | М. С. Christensen |
| collection | DOAJ |
| description | Summary. With symptomatic remission and functional recovery as the overarching therapeutic objectives of antidepressant therapy, composite endpoint measures that conjointly consider both aspects of treatment are needed. This analysis evaluated the combined effect of vortioxetine on depressive symptoms and functional capacity in adults with MDD.Methods: NCT01564862, a multinational, double-blind, placebo-controlled, duloxetine-referenced study, con-ducted between April 2012 and February 2014, in 602 adult outpatients (18–65 years) with moderate-tosevere MDD (Montgomery-Asberg Depression Rating Scale (MADRS) ≥ 26), a major depressive episode of ≥ 3 months’ duration, and self-reported cognitive symptoms were randomized to once-daily vortioxetine (10 or 20 mg), duloxetine (60 mg), or placebo for 8 weeks. Assessments included the University of California San Diego Performance-based Skills Assessment (UPSA) and the MADRS. Two versions of UPSA were utilized; UPSA ‒Validation of Intermediate Measures and UPSA Brief form. An aligned UPSA-B (communication and finance items) was examined for sensitivity analysis. Efficacy was analyzed versus placebo according to the dualresponse (change from baseline in UPSA ≥ 7 and ≥ 9 and reduction in MADRS total score from baseline ≥ 50%).Results: Significantly more vortioxetine-treated patients were classified as dual responders for change in MADRS total score and UPSA score of ≥ 7 (clinically important difference [CID]) (27.4% vs 14.5%; P = 0.004), and change above CID (≥ 9) (23.4% vs 13.9%; P = 0.025). Duloxetine did not differ significantly from placebo for these dual response criteria. Sensitivity analysis using the aligned UPSA-B confirmed these results for vortiox-etine. |
| format | Article |
| id | doaj-art-eb87aa34fa0043338bf0a6ebc262ee18 |
| institution | DOAJ |
| issn | 2313-7053 2713-055X |
| language | Russian |
| publishDate | 2019-07-01 |
| publisher | Federal State Budget Scientific Institution National Medical Research Center for Psychiatry and Neurology n.a. V.M. Bekhterev Ministry of Health of the Russian Federation |
| record_format | Article |
| series | Обозрение психиатрии и медицинской психологии имени В.М. Бехтерева |
| spelling | doaj-art-eb87aa34fa0043338bf0a6ebc262ee182025-08-20T03:20:22ZrusFederal State Budget Scientific Institution National Medical Research Center for Psychiatry and Neurology n.a. V.M. Bekhterev Ministry of Health of the Russian FederationОбозрение психиатрии и медицинской психологии имени В.М. Бехтерева2313-70532713-055X2019-07-01026974247Vortioxetine improves symptomatic and functional outcomes in major depressive disorder: a novel dual outcome measure in depressive disordersМ. С. ChristensenН. LoftR. S. McIntyreSummary. With symptomatic remission and functional recovery as the overarching therapeutic objectives of antidepressant therapy, composite endpoint measures that conjointly consider both aspects of treatment are needed. This analysis evaluated the combined effect of vortioxetine on depressive symptoms and functional capacity in adults with MDD.Methods: NCT01564862, a multinational, double-blind, placebo-controlled, duloxetine-referenced study, con-ducted between April 2012 and February 2014, in 602 adult outpatients (18–65 years) with moderate-tosevere MDD (Montgomery-Asberg Depression Rating Scale (MADRS) ≥ 26), a major depressive episode of ≥ 3 months’ duration, and self-reported cognitive symptoms were randomized to once-daily vortioxetine (10 or 20 mg), duloxetine (60 mg), or placebo for 8 weeks. Assessments included the University of California San Diego Performance-based Skills Assessment (UPSA) and the MADRS. Two versions of UPSA were utilized; UPSA ‒Validation of Intermediate Measures and UPSA Brief form. An aligned UPSA-B (communication and finance items) was examined for sensitivity analysis. Efficacy was analyzed versus placebo according to the dualresponse (change from baseline in UPSA ≥ 7 and ≥ 9 and reduction in MADRS total score from baseline ≥ 50%).Results: Significantly more vortioxetine-treated patients were classified as dual responders for change in MADRS total score and UPSA score of ≥ 7 (clinically important difference [CID]) (27.4% vs 14.5%; P = 0.004), and change above CID (≥ 9) (23.4% vs 13.9%; P = 0.025). Duloxetine did not differ significantly from placebo for these dual response criteria. Sensitivity analysis using the aligned UPSA-B confirmed these results for vortiox-etine.https://www.bekhterevreview.com/jour/article/view/250 |
| spellingShingle | М. С. Christensen Н. Loft R. S. McIntyre Vortioxetine improves symptomatic and functional outcomes in major depressive disorder: a novel dual outcome measure in depressive disorders Обозрение психиатрии и медицинской психологии имени В.М. Бехтерева |
| title | Vortioxetine improves symptomatic and functional outcomes in major depressive disorder: a novel dual outcome measure in depressive disorders |
| title_full | Vortioxetine improves symptomatic and functional outcomes in major depressive disorder: a novel dual outcome measure in depressive disorders |
| title_fullStr | Vortioxetine improves symptomatic and functional outcomes in major depressive disorder: a novel dual outcome measure in depressive disorders |
| title_full_unstemmed | Vortioxetine improves symptomatic and functional outcomes in major depressive disorder: a novel dual outcome measure in depressive disorders |
| title_short | Vortioxetine improves symptomatic and functional outcomes in major depressive disorder: a novel dual outcome measure in depressive disorders |
| title_sort | vortioxetine improves symptomatic and functional outcomes in major depressive disorder a novel dual outcome measure in depressive disorders |
| url | https://www.bekhterevreview.com/jour/article/view/250 |
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