{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,26]],"date-time":"2026-09-26T23:58:32Z","timestamp":1790467112991,"version":"4.1.0"},"reference-count":50,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2021,1,9]],"date-time":"2021-01-09T00:00:00Z","timestamp":1610150400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Bipolar Disorders"],"published-print":{"date-parts":[[2021,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objectives<\/jats:title><jats:p>Endoxifen is a protein kinase C inhibitor. The objective of the present phase III study was to demonstrate the safety and efficacy of endoxifen in treating bipolar I disorder (BPD I) patients.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A multicenter, double\u2010blind, active\u2010controlled study was conducted using a daily dose of 8\u00a0mg endoxifen compared to 1000\u00a0mg divalproex, the current standard treatment, in patients with BPD I acute manic episodes with\/without mixed features. The primary endpoint of our study was the mean change in total Young Mania Rating Scale (YMRS) score at day 21.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Endoxifen (n\u00a0=\u00a0116) significantly (<jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.0001) reduced total YMRS score (from 33.1 to 17.8. A significant (<jats:italic>p<\/jats:italic>\u00a0&lt;\u00a00.001) improvement in Montgomery\u2013\u00c5sberg Depression Rating Scale (MADRS) score was observed for endoxifen (4.8 to 2.5). Early time to remission of the disease was observed with endoxifen compared to divalproex. None of the patients required rescue medication and there was no drug\u2010associated withdrawals. Changes in Clinical Global Impressions\u2010Bipolar Disorder and Clinical Global Impression\u2010Severity of Illness scores showed that treatment with endoxifen was well\u2010tolerated.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Endoxifen at a low daily dose of 8\u00a0mg was as efficacious and safe in patients with BPD I acute manic episodes with\/without mixed features.<\/jats:p><\/jats:sec>","DOI":"10.1111\/bdi.13041","type":"journal-article","created":{"date-parts":[[2020,12,26]],"date-time":"2020-12-26T07:47:41Z","timestamp":1608968861000},"page":"595-603","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":34,"title":["Endoxifen: A new, protein kinase C inhibitor to treat acute and mixed mania associated with bipolar I disorder"],"prefix":"10.1111","volume":"23","author":[{"given":"Ateeq","family":"Ahmad","sequence":"first","affiliation":[{"name":"Jina Pharmaceuticals Inc Libertyville IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saifuddin","family":"Sheikh","sequence":"additional","affiliation":[{"name":"Jina Pharmaceuticals Inc Libertyville IL USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mujtaba Ali","family":"Khan","sequence":"additional","affiliation":[{"name":"Intas Pharmaceuticals Ltd Ahmedabad Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alok","family":"Chaturvedi","sequence":"additional","affiliation":[{"name":"Intas Pharmaceuticals Ltd Ahmedabad Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Piyush","family":"Patel","sequence":"additional","affiliation":[{"name":"Intas Pharmaceuticals Ltd Ahmedabad Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ronak","family":"Patel","sequence":"additional","affiliation":[{"name":"Lambda Therapeutic Research Ltd Ahmedabad Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bakul Chandrakant","family":"Buch","sequence":"additional","affiliation":[{"name":"Shri Hatkesh Healthcare Foundation Junagadh Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rajendra Someshwar","family":"Anand","sequence":"additional","affiliation":[{"name":"Kanoria Hospital and Research Centre Gandhinagar Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Timirkumar Chandrakant","family":"Shah","sequence":"additional","affiliation":[{"name":"Divyam Hospital Surat Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vaishal Nareshchandra","family":"Vora","sequence":"additional","affiliation":[{"name":"Ratandeep Multispecialty Hospital Ahmedabad Gujarat India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vikhram","family":"Ramasubramanian","sequence":"additional","affiliation":[{"name":"Ahana Hospitals Madurai Tamil Nadu India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Satyanarayana","family":"Rao","sequence":"additional","affiliation":[{"name":"JSS Medical College Hospital Mysore Karnataka India"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Narendra","family":"Kumar","sequence":"additional","affiliation":[{"name":"Mysore Medical College and Research Institute K.R. 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