{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T21:04:08Z","timestamp":1783026248744,"version":"3.54.6"},"reference-count":36,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,8,1]],"date-time":"2022-08-01T00:00:00Z","timestamp":1659312000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,8,1]],"date-time":"2022-08-01T00:00:00Z","timestamp":1659312000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"name":"GSK","award":["113783"],"award-info":[{"award-number":["113783"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Bipolar Disord"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Lamotrigine is approved as a maintenance therapy for bipolar I disorder in many countries, including China in 2021. This study evaluated the efficacy and safety of lamotrigine in controlling relapse and\/or recurrence of mood episodes in Chinese patients with bipolar I disorder.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Patients aged\u2009\u2265\u200918\u00a0years with bipolar I disorder who met response criteria (Clinical Global Impression\u2013Severity [CGI-S] score of\u2009\u2264\u20093 for\u2009\u2265\u20094 consecutive weeks) during treatment with lamotrigine in a 6\u201316\u00a0week open-label (OL) phase, and who were maintained for\u2009\u2265\u20091\u00a0week on lamotrigine 200\u00a0mg\/day monotherapy, were randomised (1:1) to continue receiving lamotrigine 200\u00a0mg\/day or switch to placebo in a 36-week randomised double-blind (RD) phase. The primary efficacy outcome measure was time from entry into the RD phase to intervention for relapse and\/or recurrence of a mood episode (TIME). Post hoc analyses assessed the impact of OL baseline mood severity on TIME. Safety assessments were conducted throughout the study.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Of 420 patients treated in the OL phase, 264 were randomised to receive lamotrigine (n\u2009=\u2009131) or placebo (n\u2009=\u2009133). Overall, 112 patients had an intervention for relapse and\/or recurrence of a mood episode (lamotrigine, n\u2009=\u200950\/130 [38.5%]; placebo, n\u2009=\u200962\/133 [46.6%]), with no significant difference in TIME between groups (adjusted hazard ratio [95% confidence interval (CI)] 0.93 [0.64, 1.35]; p\u2009=\u20090.701). Post hoc analyses indicated a significant difference in TIME, favouring lamotrigine over placebo, for patients with baseline CGI-S score\u2009\u2265\u20094 (hazard ratio [95% CI] 0.52 [0.30, 0.89]; p\u2009=\u20090.018) and with baseline Hamilton Depression Rating Scale\u2009\u2265\u200918 or Young Mania Rating Scale\u2009\u2265\u200910 (0.44 [hazard ratio [95% CI] 0.25, 0.78]; p\u2009=\u20090.005). Lamotrigine was well tolerated with no new safety signals.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Lamotrigine was not significantly superior to placebo in preventing relapse and\/or recurrence of mood episodes in this study of Chinese patients with bipolar I disorder but post hoc analyses suggested a therapeutic benefit in patients with moderate\/severe mood symptoms at baseline. The discrepancy between these findings and the positive findings of the pivotal studies may be attributable to the symptom severity of the bipolar patients recruited, a high dropout rate, and the comparatively short duration of the RD phase rather than race\/ethnicity differences.<\/jats:p>\n                <jats:p><jats:italic>Clinical trial registration<\/jats:italic> ClinicalTrial.gov Identifier NCT01602510; 21st May 2012; <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"uri\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01602510\">https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01602510<\/jats:ext-link>.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s40345-022-00266-4","type":"journal-article","created":{"date-parts":[[2022,8,1]],"date-time":"2022-08-01T03:24:47Z","timestamp":1659324287000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["A randomised, double-blind, placebo-controlled study to evaluate the safety and efficacy of lamotrigine in the maintenance treatment of Chinese adult patients with bipolar I disorder"],"prefix":"10.1186","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct01602510","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Ling","family":"Zhang","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Honggeng","family":"Zhang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lu-xian","family":"Lv","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Qingrong","family":"Tan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xiufeng","family":"Xu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jian","family":"Hu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lu","family":"Zi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"James","family":"Cooper","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Abhay","family":"Phansalkar","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gang","family":"Wang","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,8,1]]},"reference":[{"issue":"16","key":"266_CR1","doi-asserted-by":"publisher","first-page":"1170","DOI":"10.1016\/j.jpsychires.2010.04.009","volume":"44","author":"M Bauer","year":"2010","unstructured":"Bauer M, Glenn T, Rasgon N, Marsh W, Sagduyu K, Munoz R, et al. 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