{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T16:52:17Z","timestamp":1792687937812,"version":"4.5.0"},"reference-count":40,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2023,6,21]],"date-time":"2023-06-21T00:00:00Z","timestamp":1687305600000},"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":[[2023,9]]},"abstract":"<jats:sec><jats:label\/><jats:p>[Corrections added on 20 December 2024, after first online publication: The Results section in the Abstract has been revised to report on updated data following the re\u2010analysis of the study results using revised numbers of patients in the three groups \u2010 zuranolone 20 mg [N=84], zuranolone 30 mg [N=79], and placebo [N=79] \u2010 that were included in the full analyses set and the safety analysis set.]<\/jats:p><\/jats:sec><jats:sec><jats:title>Aim<\/jats:title><jats:p>To evaluate the efficacy and safety of an oral, once\u2010daily, 14\u2010day treatment course of zuranolone in Japanese patients with major depressive disorder (MDD).<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This multicenter, randomized, double\u2010blind, placebo\u2010controlled study randomized eligible patients (1:1:1) to receive oral zuranolone 20\u2009mg, zuranolone 30\u2009mg, or placebo once daily for 14\u2009days (treatment\u2010period), followed by two 6\u2010week follow\u2010up periods. The primary endpoint was change from baseline in the 17\u2010item Hamilton Depression Rating Scale (HAMD\u201017) total score on Day 15.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Overall, 250 patients (enrolled: 07\/07\/2020\u201305\/26\/2021) were randomized, of whom 79 in the placebo group, 84 in the zuranolone 20\u2010mg group, and 79 in the zuranolone 30\u2010mg group were included in the full analysis set (FAS) population. The demographic and baseline characteristics were balanced between groups. The adjusted mean (standard error) change from baseline in the HAMD\u201017 total score on Day 15 was \u22126.09 (0.64), \u22128.18 (0.63), and\u2009\u2212\u20098.33 (0.65) in the placebo, zuranolone 20\u2010mg, and zuranolone 30\u2010mg groups, respectively. Significant differences in the adjusted mean (95% confidence interval [CI]) for the zuranolone 20\u2010mg versus placebo (\u22122.09; [\u22123.86, \u22120.33]; <jats:italic>P<\/jats:italic>\u2009=\u20090.0204) and zuranolone 30\u2010mg versus placebo (\u22122.24; [\u22124.03, \u22120.45]; <jats:italic>P<\/jats:italic>\u2009=\u20090.0146) groups were observed on Day 15, and also as early as Day 3 for zuranolone 30 mg. A nonsignificant yet distinct drug\u2010placebo separation was observed in the zuranolone 30\u2010mg group during follow\u2010up. Somnolence (placebo [3.8%], zuranolone 20\u2009mg [10.7%], and zuranolone 30\u2009mg [21.5%]) and dizziness (2.5%, 9.5%, and 8.9%, respectively) were more common drug reactions in the treatment period with zuranolone.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Oral zuranolone was safe and demonstrated significant improvements in depressive symptoms, as assessed by the HAMD\u201017 total score change from baseline over 14\u2009days in Japanese patients with MDD.<\/jats:p><\/jats:sec>","DOI":"10.1111\/pcn.13569","type":"journal-article","created":{"date-parts":[[2023,5,30]],"date-time":"2023-05-30T16:23:42Z","timestamp":1685463822000},"page":"497-509","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["Efficacy and safety of zuranolone in Japanese adults with major depressive disorder: A double\u2010blind, randomized, placebo\u2010controlled, phase 2 clinical trial"],"prefix":"10.1111","volume":"77","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6727-7272","authenticated-orcid":false,"given":"Masaki","family":"Kato","sequence":"first","affiliation":[{"name":"Department of Neuropsychiatry Kansai Medical University  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2919-8180","authenticated-orcid":false,"given":"Kazuyuki","family":"Nakagome","sequence":"additional","affiliation":[{"name":"Department of Psychiatry National Center of Neurology and Psychiatry  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takamichi","family":"Baba","sequence":"additional","affiliation":[{"name":"Biostatistics Center, Drug Development and Regulatory Science Division Shionogi &amp; Co., Ltd.  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