{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,11]],"date-time":"2026-02-11T03:05:12Z","timestamp":1770779112204,"version":"3.50.0"},"reference-count":32,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2021,5,21]],"date-time":"2021-05-21T00:00:00Z","timestamp":1621555200000},"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":[[2021,7]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>The aim of this study was to evaluate the efficacy of lurasidone in acute schizophrenia in Japan and other countries.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Subjects (aged 18\u201374\u2009years) diagnosed with schizophrenia were randomized to lurasidone 40 mg\/day or placebo. The primary efficacy endpoint was change from baseline on the Positive and Negative Syndrome Scale (PANSS) total score at Week 6. Secondary efficacy assessments included the Clinical Global Impression\u2010Severity Scale (CGI\u2010S). Safety endpoints included adverse events, and laboratory and electrocardiogram parameters.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A total of 483 subjects were randomized to lurasidone or placebo; 107 subjects were from Japan. Mean changes from baseline at Week 6 endpoint in PANSS total scores were \u221219.3 in the lurasidone group and \u221212.7 in the placebo group (treatment difference: <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001, effect size\u00a0=\u00a00.41). Changes from baseline for Week 6 CGI\u2010S scores were \u22121.0 for lurasidone and \u22120.7 for placebo (treatment difference: <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.001, effect size\u00a0=\u00a00.41). All\u2010cause discontinuation during the 6\u2010week, double\u2010blind period was 19.4% for lurasidone and 25.4% for placebo, and discontinuation rates due to adverse event were 5.7% for lurasidone and 6.4% for placebo. The following common treatment\u2010emergent adverse events occurred in more than 2% on lurasidone and at a rate at least twice that of the placebo group: akathisia (4.0%), dizziness (2.8%), somnolence (2.8%), abdominal discomfort (2.0%) and asthenia (2.0%). No significant changes in bodyweight or metabolic parameters were observed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Lurasidone 40 mg once daily dosing demonstrated efficacy in a patient population with acute schizophrenia, including subjects from Japan, and was generally safe and well\u2010tolerated.<\/jats:p><\/jats:sec>","DOI":"10.1111\/pcn.13221","type":"journal-article","created":{"date-parts":[[2021,4,23]],"date-time":"2021-04-23T08:46:07Z","timestamp":1619167567000},"page":"227-235","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":21,"title":["Efficacy and safety of lurasidone in acutely psychotic patients with schizophrenia: A 6\u2010week, randomized, double\u2010blind, placebo\u2010controlled study"],"prefix":"10.1111","volume":"75","author":[{"given":"Masaomi","family":"Iyo","sequence":"first","affiliation":[{"name":"Department of Psychiatry Graduate School of Medicine, Chiba University  Chiba Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jun","family":"Ishigooka","sequence":"additional","affiliation":[{"name":"Institute of CNS Pharmacology  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Masatoshi","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Department of Data Science, Drug Development Division Sumitomo Dainippon Pharma Co., Ltd.  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New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alison","family":"Fitzgerald","sequence":"additional","affiliation":[{"name":"Division of Clinical Operations Sunovion Pharmaceuticals Inc.  New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4925-8665","authenticated-orcid":false,"given":"Tadashi","family":"Nosaka","sequence":"additional","affiliation":[{"name":"Medical Affairs Sumitomo Dainippon Pharma Co., Ltd.  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Teruhiko","family":"Higuchi","sequence":"additional","affiliation":[{"name":"Japan Depression Center  Tokyo Japan"},{"name":"National Center of Neurology and Psychiatry  Tokyo Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,5,21]]},"reference":[{"key":"e_1_2_8_2_1","unstructured":"World Health Organization.Schizophrenia Fact Sheet.2019. 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