{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T02:04:24Z","timestamp":1780452264457,"version":"3.54.1"},"reference-count":14,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2024,4,30]],"date-time":"2024-04-30T00:00:00Z","timestamp":1714435200000},"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":["Neuropsychopharm Rep"],"published-print":{"date-parts":[[2024,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>This study aimed to verify the real\u2010world efficacy and safety of quetiapine fumarate extended\u2010release tablets (Bipresso\u00ae 50\u2009mg and 150\u2009mg; marketing authorization holder is KYOWA Pharmaceutical Industry Co., Ltd., Osaka, Japan) in patients with bipolar depression.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>We performed a post\u2010marketing surveillance with an observation period of 12\u2009weeks.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>In the safety analysis group (<jats:italic>n<\/jats:italic>\u2009=\u2009345), adverse drug reactions (ADRs) occurred in 111 patients (32.17%). The most common ADRs (&gt;1%) were somnolence in 55 patients (15.94%), akathisia in 11 (3.19%), dizziness in 10 (2.90%), weight increase in 6 (1.74%), thirst in 5 (1.45%), and hypersomnia, constipation, and nausea in 4 patients each (1.16%). The only severe ADR was one patient of suicidal ideation, and \u201clonger time since the onset of the first episode\u201d (<jats:italic>p<\/jats:italic>\u2009=\u20090.011) and \u201cpresence of complications\u201d (<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001) were identified as significant risk factors for the occurrence of ADRs. In the efficacy analysis group (<jats:italic>n<\/jats:italic>\u2009=\u2009265), the average changes from baseline in the total Montgomery\u2013\u00c5sberg Depression Rating Scale (MADRS) score were \u22127.3\u2009\u00b1\u20098.8, \u221212.2\u2009\u00b1\u200910.7, \u221216.8\u2009\u00b1\u200912.7, and \u221213.2\u2009\u00b1\u200912.7 points after 4, 8, and 12\u2009weeks, and at the last evaluation, respectively. The mean MADRS total score decrease had no significant association with maximum daily dose, diagnosis, and presence or absence of prior or concomitant treatment for bipolar disorder with mood stabilizers\/antipsychotics\/antidepressants.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The efficacy of quetiapine fumarate extended\u2010release tablets was confirmed in clinical practice, and no new safety concerns or risks were identified.<\/jats:p><\/jats:sec>","DOI":"10.1002\/npr2.12441","type":"journal-article","created":{"date-parts":[[2024,4,30]],"date-time":"2024-04-30T08:40:27Z","timestamp":1714466427000},"page":"424-436","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Post\u2010marketing surveillance of quetiapine fumarate extended\u2010release tablets in patients with bipolar depression"],"prefix":"10.1002","volume":"44","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9237-2236","authenticated-orcid":false,"given":"Taro","family":"Kishi","sequence":"first","affiliation":[{"name":"Department of Psychiatry Fujita Health University School of Medicine  Toyoake Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nakao","family":"Iwata","sequence":"additional","affiliation":[{"name":"Department of Psychiatry Fujita Health University School of Medicine  Toyoake Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0001-5903-6505","authenticated-orcid":false,"given":"Hiroyuki","family":"Irie","sequence":"additional","affiliation":[{"name":"KYOWA Pharmaceutical Industry Co., Ltd.  Kita\u2010ku Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masaru","family":"Aikawa","sequence":"additional","affiliation":[{"name":"KYOWA Pharmaceutical Industry Co., Ltd.  Kita\u2010ku Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,4,30]]},"reference":[{"key":"e_1_2_13_2_1","unstructured":"OgasawaraK KobayashiM KondoR TakaharaM.Bipolar disorder guidelines of the Japanese Society of mood disorders; disease characteristics\u2010section\u00a01. Japanese. [updated May 2002; cited 9 Jul 2000].2023. p.17\u201319. Available from:https:\/\/www.secretariat.ne.jp\/jsmd\/iinkai\/katsudou\/data\/guideline_sokyoku2023.pdf"},{"key":"e_1_2_13_3_1","first-page":"177","volume-title":"Schizophrenia: breaking down the barriers","author":"Goldstein JM","year":"1996"},{"key":"e_1_2_13_4_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.npp.1301646"},{"key":"e_1_2_13_5_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41380-021-01334-4"},{"key":"e_1_2_13_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/bdi.13164"},{"key":"e_1_2_13_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S2215-0366(23)00199-2"},{"key":"e_1_2_13_8_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41380-020-00946-6"},{"key":"e_1_2_13_9_1","unstructured":"TanakaT NakatoY ToyoshimaK.Bipolar disorder guidelines of the Japanese society of mood disorders; depressive episodes\u2010section\u00a03. Japanese. [updated May 2002; cited 9 Jul 2000].2023. p.58\u201384. Available from:https:\/\/www.secretariat.ne.jp\/jsmd\/iinkai\/katsudou\/data\/guideline_sokyoku2023.pdf"},{"key":"e_1_2_13_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/bdi.12609"},{"issue":"10","key":"e_1_2_13_11_1","first-page":"809","article-title":"Updating the WHO model lists of essential medicines to promote global access to the most cost\u2010effective and safe medicines for mental disorders lancet","volume":"10","author":"Papola D","year":"2023","journal-title":"Psychiatry"},{"key":"e_1_2_13_12_1","unstructured":"KYOWA Pharmaceutical Industry Co. Ltd. Interview forms of bipresso\u00ae extended release tablets 50 mg and 150 mg.12th ed.Japanese.2023. Available from:https:\/\/www.info.pmda.go.jp\/go\/interview\/2\/672173_1179042G1025_2_003_1F.pdf"},{"key":"e_1_2_13_13_1","first-page":"531","article-title":"Bipresso\u00ae extended release tablets 50 mg, 150 mg (quetiapine fumarate) [Japanese]","volume":"24","author":"Kato R","year":"2018","journal-title":"Rex Info"},{"key":"e_1_2_13_14_1","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.162.7.1351"},{"key":"e_1_2_13_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpsychires.2019.05.020"}],"container-title":["Neuropsychopharmacology Reports"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/npr2.12441","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,12,2]],"date-time":"2024-12-02T05:51:09Z","timestamp":1733118669000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/npr2.12441"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4,30]]},"references-count":14,"journal-issue":{"issue":"2","published-print":{"date-parts":[[2024,6]]}},"alternative-id":["10.1002\/npr2.12441"],"URL":"https:\/\/doi.org\/10.1002\/npr2.12441","archive":["Portico"],"relation":{},"ISSN":["2574-173X","2574-173X"],"issn-type":[{"value":"2574-173X","type":"print"},{"value":"2574-173X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2024,4,30]]},"assertion":[{"value":"2023-12-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-03-25","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2024-04-30","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}