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Measures of adverse events and safety included treatment-emergent adverse events, vital signs, body weight, ECG, laboratory tests, and measures of suicidality and extrapyramidal symptoms. Symptom measures included Montgomery \u00c5sberg Depression Rating Scale (MADRS) and Young Mania Rating Scale (YMRS).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>The most common adverse events associated with lurasidone were akathisia (30.7%), nasopharyngitis (26.6%), nausea (12.1%), and somnolence (12.1%). Minimal changes in lipids and measures of glycemic control occurred. Mean change in body weight was\u2009+\u20091.0\u00a0kg in the non-depressed group and \u2212\u00a00.8\u00a0kg in the depressed group. MADRS total scores declined by a mean (SD) of 2.0 (14.7) points from long-term baseline to endpoint in the depressed group who had received placebo in the prior 6\u00a0week trial. The depressed group that had received lurasidone during the prior 6\u00a0week study maintained their depressive symptom improvements. For the non-depressed group, YMRS total scores decreased over time.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Limitations<\/jats:title>\n                <jats:p>No control group was included, treatment was open-label, and 49.7% of patients completed the 52\u00a0week study.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Long-term treatment with lurasidone 20\u2013120\u00a0mg\/day for Japanese patients with bipolar disorder maintained improvements in depressive symptoms for depressed patients who were treated in a prior 6\u00a0week trial and led to improvements in manic symptoms among a newly recruited subgroup of patients with a recent\/current manic, hypomanic, or mixed episode. Few changes in weight or metabolic parameters were evident.<\/jats:p>\n                <jats:p><jats:italic>Clinical trial registration:<\/jats:italic> JapicCTI-132319, clinicaltrials.gov\u2014NCT01986114.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s40345-021-00230-8","type":"journal-article","created":{"date-parts":[[2021,8,3]],"date-time":"2021-08-03T10:02:58Z","timestamp":1627984978000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Lurasidone in the long-term treatment of Japanese patients with bipolar I disorder: a 52\u00a0week open label study"],"prefix":"10.1186","volume":"9","author":[{"given":"Teruhiko","family":"Higuchi","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Tadafumi","family":"Kato","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mari","family":"Miyajima","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kei","family":"Watabe","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takahiro","family":"Masuda","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1389-1474","authenticated-orcid":false,"given":"Katsuhiko","family":"Hagi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jun","family":"Ishigooka","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2021,8,2]]},"reference":[{"key":"230_CR1","doi-asserted-by":"publisher","first-page":"448","DOI":"10.1186\/s12888-016-1143-8","volume":"16","author":"Y Bai","year":"2016","unstructured":"Bai Y, Li C, Tsai S, Tu PC, Chen MH, Su TP. 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The studies were conducted in accordance with the International Conference on Harmonization Good Clinical Practices guidelines and with the ethical principles of the Declaration of Helsinki. All patients reviewed and signed an informed consent document explaining study procedures and potential risks prior to enrollment in the 52\u00a0week long-term treatment study.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"All authors consent to the publication of the manuscript in International Journal of Bipolar Disorders.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"<i>Teruhiko Higuchi<\/i> reports personal fees from Meiji Seika Pharma, MSD, Allergan, Eisai, Pfizer, Janssen, Lundbeck, Shionogi, Yoshitomi, Kyowa Hakko Kirin, Mochida, Otsuka, Sumitomo Dainippon, Mitsubishi Tanabe, Eli Lilly, and Takeda. <i>Tadafumi Kato<\/i> reports personal fees from Kyowa Hakko Kirin, Eli Lilly, Otsuka Pharmaceutical, GlaxoSmithKline, Taisho Toyama Pharmaceutical, Sumitomo Dainippon Pharma, Meiji Seika Pharma Pfizer, Mochida Pharmaceutical, Shionogi, Janssen Pharmaceutical, Janssen Asia Pacific, Yoshitomiyakuhin, Astellas Pharma, Wako Pure Chemical Industries, Wiley Publishing Japan, Nippon Boehringer Ingelheim Kanae Foundation for the Promotion of Medical Science, MSD, Kyowa Pharmaceutical, and Takeda Pharmaceutical, and also reports a research grant from Takeda Pharmaceutical. <i>Mari Miyajima, Kei Watabe, Takahiro Masuda,<\/i> and <i>Katsuhiko Hagi<\/i> are full-time employees of Sumitomo Dainippon Pharma Co., Ltd. <i>Jun Ishigooka<\/i> reports grants from Sumitomo Dainippon during the conduct of the study, personal fees from Meiji Seika Pharma, MSD, Astellas, Novartis, Pfizer, Otsuka, Eli Lilly, Takeda, and Eisai.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"25"}}