{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,4]],"date-time":"2026-06-04T05:33:30Z","timestamp":1780551210296,"version":"3.54.1"},"reference-count":37,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2019,12,18]],"date-time":"2019-12-18T00:00:00Z","timestamp":1576627200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Psychiatry Clin Neurosci"],"published-print":{"date-parts":[[2020,2]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>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.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Japanese patients aged 20\u201375\u2009years with recurrent MDD and a Montgomery\u2013\u00c5sberg Depression Rating Scale (MADRS) score\u2009\u2265\u200926 were randomized to vortioxetine 10 or 20\u2009mg or placebo in a phase\u20103, double\u2010blind, 8\u2010week study. The primary end\u2010point was change in MADRS total score from baseline. Secondary end\u2010points included MADRS response and remission rates, change in Hamilton Rating Scale for Depression\u201017 item (HAM\u2010D17) score, and other measures of depressive symptoms, including Clinical Global Impression of Severity (CGI\u2010S), Clinical Global Impression of Improvement (CGI\u2010I), and Sheehan Disability Scale (SDS). Cognitive function was assessed using Digit Symbol Substitution Test (DSST) score and Perceived Deficits Questionnaire\u20105 item (PDQ\u20105) score.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Vortioxetine 10\u2009mg (<jats:italic>n<\/jats:italic> = 165) and 20\u2009mg (<jats:italic>n<\/jats:italic> = 163) reduced MADRS total score by 2.66 and 3.07 points versus placebo (<jats:italic>n<\/jats:italic> = 161) after 8\u2009weeks (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.01 for each dose), respectively. MADRS response and remission rates were also significantly greater with vortioxetine than with placebo (<jats:italic>P<\/jats:italic>\u2009&lt;\u20090.05 for both doses). Vortioxetine 10 and 20\u2009mg significantly improved HAM\u2010D17 score, CGI\u2010I score, and SDS total score after 8\u2009weeks. PDQ\u20105 score was significantly improved in subjects administered vortioxetine, while DSST scores showed no significant difference. Vortioxetine was generally well tolerated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Vortioxetine at both the 10\u2010 and 20\u2010mg\/day doses demonstrated robust antidepressant efficacy in Japanese patients with MDD, and was well tolerated over the 8\u2010week treatment period.<\/jats:p><\/jats:sec>","DOI":"10.1111\/pcn.12956","type":"journal-article","created":{"date-parts":[[2019,11,14]],"date-time":"2019-11-14T17:25:06Z","timestamp":1573752306000},"page":"140-148","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":38,"title":["Randomized, double\u2010blind, placebo\u2010controlled study to assess the efficacy and safety of vortioxetine in Japanese patients with major depressive disorder"],"prefix":"10.1111","volume":"74","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-5248-1289","authenticated-orcid":false,"given":"Takeshi","family":"Inoue","sequence":"first","affiliation":[{"name":"Department of Psychiatry Tokyo Medical University  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kiyofumi","family":"Sasai","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceutical Company Ltd  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tadayuki","family":"Kitagawa","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceutical Company Ltd  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-6085-6829","authenticated-orcid":false,"given":"Akira","family":"Nishimura","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceutical Company Ltd  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isao","family":"Inada","sequence":"additional","affiliation":[{"name":"Takeda Pharmaceutical Company Ltd  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2019,12,18]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(18)32279-7"},{"key":"e_1_2_8_3_1","unstructured":"Global Health Data Exchange.2017. [Cited 2 June 2019.] Available from URL:http:\/\/ghdx.healthdata.org\/gbd\u2010results\u2010tool?params=gbd\u2010api\u20102017\u2010permalink\/2d6f9b2d8d1b517ea8013450c796a170"},{"key":"e_1_2_8_4_1","first-page":"e1","article-title":"Cost of depression among adults in Japan","volume":"13","author":"Okumura Y","year":"2011","journal-title":"Prim. Care Companion CNS Disord"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00127-016-1278-4"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12889-016-3020-2"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.9058se1c.05gry"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.3389\/neuro.09.026.2009"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1176\/ajp.2006.163.11.1905"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1001\/jama.289.23.3095"},{"key":"e_1_2_8_11_1","volume-title":"The Japanese Society of Mood Disorders Treatment Guideline","author":"Iga J\u2010I","year":"2016"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00406-010-0124-z"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1002\/da.20438"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11920-017-0816-4"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1177\/2045125315612334"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1111\/pcn.12273"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1021\/jm101459g"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1037\/a0038550"},{"key":"e_1_2_8_19_1","first-page":"36","article-title":"Vortioxetine (Brintellix): A new serotonergic antidepressant","volume":"40","author":"D'Agostino A","year":"2015","journal-title":"P & T"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.brainres.2017.12.025"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(17)32802-7"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2016.02.042"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1177\/0269881116628440"},{"key":"e_1_2_8_24_1","doi-asserted-by":"publisher","DOI":"10.1038\/npp.2015.52"},{"key":"e_1_2_8_25_1","doi-asserted-by":"publisher","DOI":"10.1017\/S1092852915000553"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1093\/ijnp\/pyx070"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1093\/ijnp\/pyw055"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.16m10744"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1111\/pcn.12565"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1111\/pcn.12623"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.euroneuro.2016.03.007"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjmed.2015.07.001"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.1186\/s13643-015-0001-y"},{"key":"e_1_2_8_34_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpdd.381"},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0149-2918(03)80220-5"},{"key":"e_1_2_8_36_1","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2018.1477746"},{"key":"e_1_2_8_37_1","doi-asserted-by":"publisher","DOI":"10.1586\/14737167.2016.1128830"},{"key":"e_1_2_8_38_1","doi-asserted-by":"publisher","DOI":"10.1007\/164_2018_167"}],"container-title":["Psychiatry and Clinical Neurosciences"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/pcn.12956","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/pcn.12956","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/pcn.12956","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,9,6]],"date-time":"2023-09-06T05:00:18Z","timestamp":1693976418000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/pcn.12956"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,12,18]]},"references-count":37,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2020,2]]}},"alternative-id":["10.1111\/pcn.12956"],"URL":"https:\/\/doi.org\/10.1111\/pcn.12956","archive":["Portico"],"relation":{},"ISSN":["1323-1316","1440-1819"],"issn-type":[{"value":"1323-1316","type":"print"},{"value":"1440-1819","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,12,18]]},"assertion":[{"value":"2019-06-24","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-10-31","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2019-12-18","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}