{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,16]],"date-time":"2026-10-16T01:07:26Z","timestamp":1792112846610,"version":"4.4.0"},"reference-count":14,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2018,7,2]],"date-time":"2018-07-02T00:00:00Z","timestamp":1530489600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/501100007132","name":"Otsuka Pharmaceutical","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100007132","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Psychiatry Clin Neurosci"],"published-print":{"date-parts":[[2018,9]]},"abstract":"<jats:sec><jats:title>Aim<\/jats:title><jats:p>This study aimed to evaluate the efficacy, safety, and tolerability of brexpiprazole compared to placebo in Japanese patients with acute schizophrenia (SCZ).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We conducted a 6\u2010week, multicenter, double\u2010blind, placebo\u2010controlled, phase 2\/3 study in Japan. Patients with acute SCZ were randomized (1:1:1:1) to receive brexpiprazole 1 mg, 2 mg, 4 mg, or placebo once a day. The primary endpoint was the change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total scores.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In the 459 patients that were randomized, brexpiprazole 2 mg showed a significant improvement versus placebo (treatment difference: \u22127.32, <jats:italic>P<\/jats:italic> = 0.0124), although brexpiprazole 4 mg showed numerical improvements (treatment difference: \u22123.86, <jats:italic>P<\/jats:italic> = 0.1959), and brexpiprazole 1 mg showed only minimal change (treatment difference: \u22120.63, <jats:italic>P<\/jats:italic> = 0.8330). Treatment\u2010emergent adverse events with an incidence of \u22655% and \u22652 times the rate of placebo in the brexpiprazole groups were vomiting, elevated blood prolactin, diarrhea, nausea, and dental caries. Most treatment\u2010emergent adverse events were mild or moderate in severity. There were no clinically significant changes in electrocardiogram parameters, bodyweight, laboratory values, or vital signs in the brexpiprazole groups.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Brexpiprazole was efficacious and well tolerated in Japanese adult patients with acute SCZ.<\/jats:p><\/jats:sec>","DOI":"10.1111\/pcn.12682","type":"journal-article","created":{"date-parts":[[2018,5,18]],"date-time":"2018-05-18T08:18:55Z","timestamp":1526631535000},"page":"692-700","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":60,"title":["Efficacy and safety of brexpiprazole for the treatment of acute schizophrenia in Japan: A 6\u2010week, randomized, double\u2010blind, placebo\u2010controlled study"],"prefix":"10.1111","volume":"72","author":[{"given":"Jun","family":"Ishigooka","sequence":"first","affiliation":[{"name":"Institute of CNS Pharmacology  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shuichi","family":"Iwashita","sequence":"additional","affiliation":[{"name":"Headquarters of Clinical Development Otsuka Pharmaceutical Co., Ltd.  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9752-8949","authenticated-orcid":false,"given":"Yoshihiro","family":"Tadori","sequence":"additional","affiliation":[{"name":"Department of Medical Affairs Otsuka Pharmaceutical Co., Ltd.  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,7,2]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0896-6273(00)00111-2"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0924-9338(10)71701-6"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)60733-3"},{"key":"e_1_2_8_5_1","first-page":"1641","article-title":"Spotlight on brexpiprazole and its potential in the treatment of schizophrenia and as adjunctive therapy for the treatment of major depression","volume":"10","author":"Bruijnzeel D","year":"2016","journal-title":"Drug Des. Devel. 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