Evidence map›Paper›PMID 31725942›Full record

Trial reportPsychiatry and clinical neurosciences2020

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

Takeshi Inoue, Kiyofumi Sasai, Tadayuki Kitagawa, Akira Nishimura, Isao Inada

Abstract readClinical Trial, Phase IIIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Psychiatry and clinical neurosciences, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 25 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 6 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 6 syntheses or guidelines pooled it.

  1. Use of vortioxetine in different neurological fields: a systematic review and future perspectives.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2025
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors.

Takeshi InoueDepartment of Psychiatry, Tokyo Medical University, Tokyo, Japan.ORCID https://orcid.org/0000-0001-5248-1289
Kiyofumi SasaiTakeda Pharmaceutical Company Ltd, Osaka, Japan.
Tadayuki KitagawaTakeda Pharmaceutical Company Ltd, Osaka, Japan.
Akira NishimuraTakeda Pharmaceutical Company Ltd, Osaka, Japan.ORCID https://orcid.org/0000-0001-6085-6829
Isao InadaTakeda Pharmaceutical Company Ltd, Osaka, Japan.

Funding

Takeda
6 · The paper itself

Abstract

aimThe 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.

methodsJapanese 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.

resultsVortioxetine 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.

conclusionVortioxetine 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.

Indexed as

AdultAgedAntidepressive AgentsDouble-Blind MethodFemaleHumansJapanMajor Depressive DisorderMaleMiddle AgedOutcome Assessment, Health CareRemission InductionSeverity of Illness IndexVortioxetineYoung AdultAntidepressive AgentsVortioxetineantidepressive agentscognitionJapanesemajor depressive disordervortioxetine

Identifiers

PMID31725942
PMCPMC7027855

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.