{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,22]],"date-time":"2025-10-22T05:13:49Z","timestamp":1761110029411},"reference-count":43,"publisher":"Wiley","issue":"1","license":[{"start":{"date-parts":[[2012,2,13]],"date-time":"2012-02-13T00:00:00Z","timestamp":1329091200000},"content-version":"vor","delay-in-days":12,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Bipolar Disorders"],"published-print":{"date-parts":[[2012,2]]},"abstract":"<jats:p>Carlson BX, Ketter TA, Sun W, Timko K, McQuade RD, Sanchez R, Vester\u2010Blokland E, Marcus R. Aripiprazole in combination with lamotrigine for the long\u2010term treatment of patients with bipolar I disorder (manic or mixed): a randomized, multicenter, double\u2010blind study (CN138\u2010392). Bipolar Disord 2012: 14: 41\u201353. \u00a9 2012 The Authors. Journal compilation \u00a9 2012 John Wiley &amp; Sons A\/S.<\/jats:p><jats:p><jats:bold>Objectives:\u2002<\/jats:bold> To evaluate the efficacy and safety of aripiprazole (ARI) plus lamotrigine (LTG) compared with placebo (PBO) plus LTG, for long\u2010term treatment in bipolar I disorder patients with a recent manic\/mixed episode.<\/jats:p><jats:p><jats:bold>Methods:\u2002<\/jats:bold> After a 9\u201324\u2003week stabilization phase receiving single\u2010blind ARI (10\u201330\u2003mg\/day) plus open\u2010label LTG (100 or 200\u2003mg\/day), patients maintaining stability (Young Mania Rating Scale\/Montgomery\u2013\u00c5sberg Depression Rating Scale total scores\u2003\u2264\u200312) with ARI\u2003+\u2003LTG for eight consecutive weeks were randomized to continue on double\u2010blind ARI\u2003+\u2003LTG or to receive PBO\u2003+\u2003LTG, after removing ARI from ARI\u2003+\u2003LTG treatment, and followed up for 52\u2003weeks. The primary outcome measure was time from randomization to relapse into a manic\/mixed episode.<\/jats:p><jats:p><jats:bold>Results:\u2002<\/jats:bold> A total of 787 patients entered the stabilization phase, and 351 were randomized to ARI\u2003+\u2003LTG (n\u2003=\u2003178) or PBO\u2003+\u2003LTG (n\u2003=\u2003173). ARI\u2003+\u2003LTG yielded a numerically longer time to manic\/mixed relapse than PBO\u2003+\u2003LTG, but it was not statistically significant [hazard ratio (HR)\u2003=\u20030.55; 95% confidence interval (CI): 0.30\u20131.03; p\u2003=\u20030.058]. The estimated relapse rates at Week 52 were 11% for ARI\u2003+\u2003LTG and 23% for PBO\u2003+\u2003LTG, yielding a number needed\u2010to\u2010treat of nine (95% CI: 5\u2013121). The three most common adverse events were akathisia [10.8%, 6.1% for ARI\u2003+\u2003LTG and PBO\u2003+\u2003LTG, respectively; number needed\u2010to\u2010harm (NNH)\u2003=\u200322], insomnia (7.4%, 11.5%), and anxiety (7.4%, 3.6%). Mean weight change was 0.43\u2003kg and \u22121.81\u2003kg, respectively (last observation carried forward, p\u2003=\u20030.001). Rates of\u2003\u2265\u20037% weight gain with ARI\u2003+\u2003LTG and PBO\u2003+\u2003LTG were 11.9% and 3.5%, respectively (NNH\u2003=\u200312).<\/jats:p><jats:p><jats:bold>Conclusions:\u2002<\/jats:bold> ARI\u2003+\u2003LTG delayed the time to manic\/mixed relapse but did not reach statistical significance. Safety and tolerability results revealed no unexpected adverse events for ARI combination with LTG.<\/jats:p>","DOI":"10.1111\/j.1399-5618.2011.00974.x","type":"journal-article","created":{"date-parts":[[2012,2,13]],"date-time":"2012-02-13T15:24:42Z","timestamp":1329146682000},"page":"41-53","source":"Crossref","is-referenced-by-count":49,"title":["Aripiprazole in combination with lamotrigine for the long\u2010term treatment of patients with bipolar I disorder (manic or mixed): a randomized, multicenter, double\u2010blind study (CN138\u2010392)"],"prefix":"10.1111","volume":"14","author":[{"given":"Berit X","family":"Carlson","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Terence A","family":"Ketter","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Wei","family":"Sun","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karen","family":"Timko","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Robert D","family":"McQuade","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Raymond","family":"Sanchez","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Estelle","family":"Vester\u2010Blokland","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ronald","family":"Marcus","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,2,13]]},"reference":[{"key":"e_1_2_8_2_2","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.1108e32"},{"key":"e_1_2_8_3_2","doi-asserted-by":"publisher","DOI":"10.2165\/00019053-200119050-00004"},{"key":"e_1_2_8_4_2","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v66n0710"},{"key":"e_1_2_8_5_2","doi-asserted-by":"publisher","DOI":"10.1177\/0269881109102919"},{"key":"e_1_2_8_6_2","doi-asserted-by":"publisher","DOI":"10.1080\/15622970902823202"},{"key":"e_1_2_8_7_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1399-5618.2009.00672.x"},{"key":"e_1_2_8_8_2","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.09m05482yel"},{"key":"e_1_2_8_9_2","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2008.08020189"},{"key":"e_1_2_8_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jad.2008.06.001"},{"key":"e_1_2_8_11_2","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.184.4.337"},{"key":"e_1_2_8_12_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1399-5618.2009.00761.x"},{"key":"e_1_2_8_13_2","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.160.9.1651"},{"key":"e_1_2_8_14_2","doi-asserted-by":"publisher","DOI":"10.1177\/0269881106059693"},{"key":"e_1_2_8_15_2","doi-asserted-by":"publisher","DOI":"10.1176\/appi.ajp.2008.07101560"},{"key":"e_1_2_8_16_2","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v67n0414"},{"key":"e_1_2_8_17_2","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v68n1003"},{"key":"e_1_2_8_18_2","doi-asserted-by":"publisher","DOI":"10.1124\/jpet.102.033175"},{"key":"e_1_2_8_19_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0014-2999(02)01532-7"},{"key":"e_1_2_8_20_2","doi-asserted-by":"publisher","DOI":"10.1038\/sj.npp.1300203"},{"key":"e_1_2_8_21_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejphar.2003.10.025"},{"key":"e_1_2_8_22_2","doi-asserted-by":"publisher","DOI":"10.1007\/s00213-006-0621-y"},{"key":"e_1_2_8_23_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ejphar.2008.09.008"},{"key":"e_1_2_8_24_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1399-5618.2011.00898.x"},{"key":"e_1_2_8_25_2","doi-asserted-by":"publisher","DOI":"10.1185\/03007991003779380"},{"key":"e_1_2_8_26_2","doi-asserted-by":"publisher","DOI":"10.1001\/archpsyc.60.4.392"},{"key":"e_1_2_8_27_2","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v64n0906"},{"key":"e_1_2_8_28_2","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.v65n0321"},{"key":"e_1_2_8_29_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpsychires.2008.02.007"},{"key":"e_1_2_8_30_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1399-5618.2011.00887.x"},{"key":"e_1_2_8_31_2","doi-asserted-by":"publisher","DOI":"10.4088\/JCP.08m04152"},{"issue":"1","key":"e_1_2_8_32_2","first-page":"53","article-title":"The long\u2010term effectiveness of quetiapine plus lamotrigine therapy in bipolar patients","volume":"11","author":"Ketter TA","year":"2009","journal-title":"Bipolar Disord"},{"key":"e_1_2_8_33_2","doi-asserted-by":"publisher","DOI":"10.1192\/bjp.133.5.429"},{"key":"e_1_2_8_34_2","unstructured":"GuyW.Abnormal Involuntary Movement Scale (AIMS). 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