{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T16:51:58Z","timestamp":1792687918973,"version":"4.5.0"},"reference-count":29,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T00:00:00Z","timestamp":1771459200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T00:00:00Z","timestamp":1771459200000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["PCN Reports"],"published-print":{"date-parts":[[2026,3]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Aim<\/jats:title>\n                    <jats:p>To evaluate the safety and tolerability of repeating 14\u2010day treatment with zuranolone (30\u2009mg) followed by a 6\u2010week follow\u2010up period (one treatment cycle) for a maximum of six treatment cycles in Japanese participants with major depressive disorder.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>This multicenter Phase 3 study was conducted in two parts (70 sites; Japan). Part B was an open\u2010label study for participants who completed the initial double\u2010blind study (Part A; zuranolone vs. placebo) in which all eligible participants received zuranolone regardless of their assignments in Part A. Endpoints included treatment\u2010emergent adverse events (TEAEs) and efficacy using the 17\u2010item Hamilton Depression Rating Scale (HAMD\u201017).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 271, 213, 170, 147, 126, and 99 participants were evaluated in Cycles 1\u20136, respectively. TEAEs occurring in \u22655% of participants were somnolence and dizziness during the treatment period and nasopharyngitis during the follow\u2010up period, and no new safety signals were observed with increased numbers of treatment cycles. Additionally, no TEAEs suggestive of drug dependence or withdrawal symptoms were identified. The HAMD\u201017 total score decreased by 8 and 15 days after the initiation of zuranolone in all six cycles, and there were no meaningful differences in the HAMD\u201017 total score reduction across treatment cycles.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>In this open\u2010label part of the Phase 3 study in Japan, zuranolone decreased the HAMD\u201017 total scores from baseline over 15 days during repeated treatment cycles in patients with major depressive disorder, without any new safety signals.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/pcn5.70302","type":"journal-article","created":{"date-parts":[[2026,2,19]],"date-time":"2026-02-19T11:44:46Z","timestamp":1771501486000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Safety and efficacy of zuranolone in Japanese adults with major depressive disorder: An open\u2010label, repeated\u2010treatment part of a Phase 3 clinical trial"],"prefix":"10.1002","volume":"5","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"}]},{"given":"Kazuyuki","family":"Nakagome","sequence":"additional","affiliation":[{"name":"Department of Psychiatry National Center of Neurology and Psychiatry Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4968-2642","authenticated-orcid":false,"given":"Takamichi","family":"Baba","sequence":"additional","affiliation":[{"name":"Drug Development and Regulatory Science Division Shionogi &amp; Co., Ltd. Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuhiro","family":"Sonoyama","sequence":"additional","affiliation":[{"name":"Drug Development and Regulatory Science Division Shionogi &amp; Co., Ltd. Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-8990-8175","authenticated-orcid":false,"given":"Hiroki","family":"Fukuju","sequence":"additional","affiliation":[{"name":"Drug Development and Regulatory Science Division Shionogi &amp; Co., Ltd. Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryosuke","family":"Shimizu","sequence":"additional","affiliation":[{"name":"Drug Development and Regulatory Science Division Shionogi &amp; Co., Ltd. Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Juan Carlos","family":"Gomez","sequence":"additional","affiliation":[{"name":"Drug Development and Regulatory Science Division Shionogi B.V. London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2558-4263","authenticated-orcid":false,"given":"Tomoko","family":"Motomiya","sequence":"additional","affiliation":[{"name":"Drug Development and Regulatory Science Division Shionogi &amp; Co., Ltd. Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5248-1289","authenticated-orcid":false,"given":"Takeshi","family":"Inoue","sequence":"additional","affiliation":[{"name":"Department of Psychiatry Tokyo Medical University Tokyo Japan"},{"name":"Department of Psychiatry Sapporo Hanazono Hospital Hokkaido Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2026,2,19]]},"reference":[{"key":"e_1_2_14_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41398-021-01227-8"},{"key":"e_1_2_14_3_1","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.2018.27"},{"key":"e_1_2_14_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0924-977X(02)00173-6"},{"key":"e_1_2_14_5_1","doi-asserted-by":"publisher","DOI":"10.1017\/S1092852921000936"},{"key":"e_1_2_14_6_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.157.9.1423"},{"key":"e_1_2_14_7_1","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v66n0201"},{"key":"e_1_2_14_8_1","doi-asserted-by":"publisher","DOI":"10.1001\/archpsyc.63.11.1217"},{"key":"e_1_2_14_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2020.01.149"},{"key":"e_1_2_14_10_1","unstructured":"Zuranolone prescribing information. 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