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Randomized, double‐blind, placebo‐controlled study to assess the efficacy and safety of vortioxetine in Japanese patients with major depressive disorder

AIM: The burden of major depressive disorder (MDD) in Japan is high. This study aimed to evaluate the efficacy and safety of the multimodal antidepressant vortioxetine in Japanese patients with MDD. METHODS: Japanese patients aged 20–75 years with recurrent MDD and a Montgomery–Åsberg Depression Rat...

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Autores principales: Inoue, Takeshi, Sasai, Kiyofumi, Kitagawa, Tadayuki, Nishimura, Akira, Inada, Isao
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons Australia, Ltd 2019
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7027855/
https://www.ncbi.nlm.nih.gov/pubmed/31725942
http://dx.doi.org/10.1111/pcn.12956
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author Inoue, Takeshi
Sasai, Kiyofumi
Kitagawa, Tadayuki
Nishimura, Akira
Inada, Isao
author_facet Inoue, Takeshi
Sasai, Kiyofumi
Kitagawa, Tadayuki
Nishimura, Akira
Inada, Isao
author_sort Inoue, Takeshi
collection PubMed
description AIM: The burden of major depressive disorder (MDD) in Japan is high. This study aimed to evaluate the efficacy and safety of the multimodal antidepressant vortioxetine in Japanese patients with MDD. METHODS: Japanese patients aged 20–75 years with recurrent MDD and a Montgomery–Åsberg Depression Rating Scale (MADRS) score ≥ 26 were randomized to vortioxetine 10 or 20 mg or placebo in a phase‐3, double‐blind, 8‐week study. The primary end‐point was change in MADRS total score from baseline. Secondary end‐points included MADRS response and remission rates, change in Hamilton Rating Scale for Depression‐17 item (HAM‐D17) score, and other measures of depressive symptoms, including Clinical Global Impression of Severity (CGI‐S), Clinical Global Impression of Improvement (CGI‐I), and Sheehan Disability Scale (SDS). Cognitive function was assessed using Digit Symbol Substitution Test (DSST) score and Perceived Deficits Questionnaire‐5 item (PDQ‐5) score. RESULTS: Vortioxetine 10 mg (n = 165) and 20 mg (n = 163) reduced MADRS total score by 2.66 and 3.07 points versus placebo (n = 161) after 8 weeks (P < 0.01 for each dose), respectively. MADRS response and remission rates were also significantly greater with vortioxetine than with placebo (P < 0.05 for both doses). Vortioxetine 10 and 20 mg significantly improved HAM‐D17 score, CGI‐I score, and SDS total score after 8 weeks. PDQ‐5 score was significantly improved in subjects administered vortioxetine, while DSST scores showed no significant difference. Vortioxetine was generally well tolerated. CONCLUSION: Vortioxetine at both the 10‐ and 20‐mg/day doses demonstrated robust antidepressant efficacy in Japanese patients with MDD, and was well tolerated over the 8‐week treatment period.
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spelling pubmed-70278552020-02-24 Randomized, double‐blind, placebo‐controlled study to assess the efficacy and safety of vortioxetine in Japanese patients with major depressive disorder Inoue, Takeshi Sasai, Kiyofumi Kitagawa, Tadayuki Nishimura, Akira Inada, Isao Psychiatry Clin Neurosci Regular Articles AIM: The burden of major depressive disorder (MDD) in Japan is high. This study aimed to evaluate the efficacy and safety of the multimodal antidepressant vortioxetine in Japanese patients with MDD. METHODS: Japanese patients aged 20–75 years with recurrent MDD and a Montgomery–Åsberg Depression Rating Scale (MADRS) score ≥ 26 were randomized to vortioxetine 10 or 20 mg or placebo in a phase‐3, double‐blind, 8‐week study. The primary end‐point was change in MADRS total score from baseline. Secondary end‐points included MADRS response and remission rates, change in Hamilton Rating Scale for Depression‐17 item (HAM‐D17) score, and other measures of depressive symptoms, including Clinical Global Impression of Severity (CGI‐S), Clinical Global Impression of Improvement (CGI‐I), and Sheehan Disability Scale (SDS). Cognitive function was assessed using Digit Symbol Substitution Test (DSST) score and Perceived Deficits Questionnaire‐5 item (PDQ‐5) score. RESULTS: Vortioxetine 10 mg (n = 165) and 20 mg (n = 163) reduced MADRS total score by 2.66 and 3.07 points versus placebo (n = 161) after 8 weeks (P < 0.01 for each dose), respectively. MADRS response and remission rates were also significantly greater with vortioxetine than with placebo (P < 0.05 for both doses). Vortioxetine 10 and 20 mg significantly improved HAM‐D17 score, CGI‐I score, and SDS total score after 8 weeks. PDQ‐5 score was significantly improved in subjects administered vortioxetine, while DSST scores showed no significant difference. Vortioxetine was generally well tolerated. CONCLUSION: Vortioxetine at both the 10‐ and 20‐mg/day doses demonstrated robust antidepressant efficacy in Japanese patients with MDD, and was well tolerated over the 8‐week treatment period. John Wiley & Sons Australia, Ltd 2019-12-18 2020-02 /pmc/articles/PMC7027855/ /pubmed/31725942 http://dx.doi.org/10.1111/pcn.12956 Text en © 2019 The Authors. Psychiatry and Clinical Neurosciences published by John Wiley & Sons Australia, Ltd on behalf of Japanese Society of Psychiatry and Neurology This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Regular Articles
Inoue, Takeshi
Sasai, Kiyofumi
Kitagawa, Tadayuki
Nishimura, Akira
Inada, Isao
Randomized, double‐blind, placebo‐controlled study to assess the efficacy and safety of vortioxetine in Japanese patients with major depressive disorder
title Randomized, double‐blind, placebo‐controlled study to assess the efficacy and safety of vortioxetine in Japanese patients with major depressive disorder
title_full Randomized, double‐blind, placebo‐controlled study to assess the efficacy and safety of vortioxetine in Japanese patients with major depressive disorder
title_fullStr Randomized, double‐blind, placebo‐controlled study to assess the efficacy and safety of vortioxetine in Japanese patients with major depressive disorder
title_full_unstemmed Randomized, double‐blind, placebo‐controlled study to assess the efficacy and safety of vortioxetine in Japanese patients with major depressive disorder
title_short Randomized, double‐blind, placebo‐controlled study to assess the efficacy and safety of vortioxetine in Japanese patients with major depressive disorder
title_sort randomized, double‐blind, placebo‐controlled study to assess the efficacy and safety of vortioxetine in japanese patients with major depressive disorder
topic Regular Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7027855/
https://www.ncbi.nlm.nih.gov/pubmed/31725942
http://dx.doi.org/10.1111/pcn.12956
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