{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,28]],"date-time":"2026-10-28T00:41:20Z","timestamp":1793148080626,"version":"4.5.0"},"reference-count":53,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2019,11,6]],"date-time":"2019-11-06T00:00:00Z","timestamp":1572998400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100007819","name":"Allergan","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100007819","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Bipolar Disorders"],"published-print":{"date-parts":[[2020,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>\n                      To assess the efficacy, safety, and tolerability of cariprazine in the treatment of the depressed phase of bipolar I disorder in adults (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"DDBJ\/EMBL\/GenBank\" xlink:href=\"NCT02670538\">NCT02670538<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      In this phase 3 double\u2010blind placebo\u2010controlled study, adult patients with bipolar I disorder according to the\n                      <jats:italic>Diagnostic and Statistical Manual \u2014 5th Edition<\/jats:italic>\n                      criteria and a current depressive episode were randomized to placebo (n\u00a0=\u00a0167), cariprazine 1.5\u00a0mg\/day (n\u00a0=\u00a0168) or cariprazine 3.0\u00a0mg\/day (n\u00a0=\u00a0158). Efficacy parameters were changes in the Montgomery\u2010\u00c5sberg Depression Rating Scale (MADRS) total scores (primary) and Clinical Global Impressions \u2014 Severity (CGI\u2010S) scores (secondary) from baseline to Week 6 compared to placebo. A mixed\u2010model for repeated measures was used to estimate the least\u2010squares mean differences (LSMD);\n                      <jats:italic>P<\/jats:italic>\n                      \u2010values were adjusted for multiplicity. Adverse events (AEs), laboratory results, vital signs, and suicide risk were monitored.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      Cariprazine 1.5\u00a0mg\/day significantly reduced depressive symptoms on the primary (MADRS LSMD\u00a0=\u00a0\u22122.5; adjusted\n                      <jats:italic>P\u00a0<\/jats:italic>\n                      =\u00a0.0417) and secondary (CGI\u2010S LSMD\u00a0=\u00a0\u22120.3; adjusted\n                      <jats:italic>P\u00a0<\/jats:italic>\n                      =\u00a0.0417) efficacy parameters vs placebo; differences were not statistically significant for cariprazine 3.0\u00a0mg\/day. Common treatment\u2010emergent AEs (\u22655% in either cariprazine group and at least twice the incidence of placebo) were akathisia, restlessness, nausea, and fatigue. Mean metabolic parameter changes were low and generally comparable among groups; mean weight increases were \u22640.5\u00a0kg for all groups.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Cariprazine 1.5\u00a0mg\/day significantly reduced depressive symptoms in adults with bipolar I depression compared to placebo, but differences were not significant for cariprazine 3.0\u00a0mg\/day. The safety and tolerability profiles were similar to previous studies of cariprazine.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/bdi.12852","type":"journal-article","created":{"date-parts":[[2019,10,18]],"date-time":"2019-10-18T22:53:41Z","timestamp":1571439221000},"page":"372-384","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":81,"title":["Efficacy and safety of cariprazine in bipolar I depression: A double\u2010blind, placebo\u2010controlled phase 3 study"],"prefix":"10.1111","volume":"22","author":[{"given":"Willie R.","family":"Earley","sequence":"first","affiliation":[{"name":"Department of Clinical Development Allergan plc Madison NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria V.","family":"Burgess","sequence":"additional","affiliation":[{"name":"Department of Clinical Development Allergan plc Madison NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Barbara","family":"Khan","sequence":"additional","affiliation":[{"name":"Department of Clinical Development Allergan plc Madison NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ludmyla","family":"Rekeda","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Allergan plc Madison NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Trisha","family":"Suppes","sequence":"additional","affiliation":[{"name":"Department of Psychiatry and Behavioral Sciences Stanford University School of Medicine and V.A. 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