Please use this identifier to cite or link to this item:
10.1097/YIC.0000000000000326
Title: | Intravenous vortioxetine to accelerate onset of effect in major depressive disorder: a 7-day randomized, double-blind, placebo-controlled exploratory study |
Authors: | Rancans, Elmars Zambori, Janos Dalsgaard, Mads Baayen, Corine Areberg, Johan Ettrup, Anders Florea, Ioana Department of Psychiatry and Narcology |
Keywords: | antidepressant;fast onset of action;intravenous administration;major depressive disorder;3.2 Clinical medicine;1.1. Scientific article indexed in Web of Science and/or Scopus database;Psychiatry and Mental health;Pharmacology (medical);SDG 3 - Good Health and Well-being |
Issue Date: | Nov-2020 |
Citation: | Rancans , E , Zambori , J , Dalsgaard , M , Baayen , C , Areberg , J , Ettrup , A & Florea , I 2020 , ' Intravenous vortioxetine to accelerate onset of effect in major depressive disorder: a 7-day randomized, double-blind, placebo-controlled exploratory study ' , International Clinical Psychopharmacology , vol. 35 , no. 6 , pp. 305-312 . https://doi.org/10.1097/YIC.0000000000000326 |
Abstract: | This 7-day randomized, double-blind, placebo-controlled fixed-dose study (NCT03766867) explored the potential for accelerating the onset of antidepressant efficacy of single-dose intravenous (IV) vortioxetine at oral vortioxetine treatment initiation. Patients (ages 18-65 years) hospitalized per standard-of-care with major depressive disorder, who were currently treated with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor for a major depressive episode [Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 30], received one dose of single-blind IV placebo (1-day placebo lead-in period) before being randomly switched to either single-dose IV vortioxetine 25 mg plus daily oral vortioxetine 10 mg (n = 39), or IV placebo plus daily oral placebo (n = 41). In the placebo lead-in period, patients improved slightly by 0.6 MADRS-6 point; however, at day 1 after randomization, both treatment groups had improved by approximately 3 MADRS-6 points (mean difference =-0.8; P = 0.263), the study thus not meeting its primary endpoint. Similar results were seen for other outcomes except a numerically larger improvement in anxiety symptoms with vortioxetine vs placebo. Pharmacokinetic data confirmed that IV vortioxetine facilitated reaching steady-state plasma concentration within 24 h. IV plus oral vortioxetine was well tolerated, with low levels of nausea as the most common adverse event. |
Description: | Publisher Copyright: © 2020 Lippincott Williams and Wilkins. All rights reserved. Copyright: Copyright 2020 Elsevier B.V., All rights reserved. |
DOI: | 10.1097/YIC.0000000000000326 |
ISSN: | 0268-1315 |
Appears in Collections: | Research outputs from Pure / Zinātniskās darbības rezultāti no ZDIS Pure |
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Intravenous_vortioxetine_to_accelerate_onset_of.3.pdf | 390.17 kB | Adobe PDF | View/Open |
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