{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,17]],"date-time":"2026-03-17T01:57:50Z","timestamp":1773712670480,"version":"3.50.1"},"reference-count":29,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2022,8,30]],"date-time":"2022-08-30T00:00:00Z","timestamp":1661817600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100009655","name":"Sunovion","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009655","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009655","name":"Sunovion","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009655","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009655","name":"Sunovion","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009655","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100009655","name":"Sunovion","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100009655","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Epilepsia Open"],"published-print":{"date-parts":[[2022,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>Eslicarbazepine acetate (ESL) is a once\u2010daily (QD), oral anti\u2010seizure medication for the treatment of focal (partial\u2010onset) seizures. Here, we evaluate risk factors for the development of psychiatric treatment\u2010emergent adverse events (TEAEs) in clinical trials of adjunctive ESL in adults with focal seizures.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>This post\u2010hoc analysis evaluated data pooled from three Phase III, randomized, double\u2010blind, placebo\u2010controlled trials (BIA\u20102093\u2010301, \u2010302, \u2010304). After an 8\u2010week baseline period, patients were randomized equally to receive placebo, ESL 400\u2009mg (not reported here), 800\u2009mg, or 1200\u2009mg QD (up to 2\u2010week titration; 12\u2010week maintenance; optional open\u2010label extension [OLE]). Incidences of psychiatric TEAEs were evaluated according to three separate criteria: medical history of psychiatric disorders (yes\/no); baseline use of psychotropic drugs (yes\/no); Montgomery\u2013\u00c5sberg Depression Rating Scale (MADRS) score at baseline (0\u20136: normal; 7\u201319: mild depression; 20\u201334: moderate depression).<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The analysis populations comprised 1251 patients for the controlled study period and 1137 patients for the 1\u2010year OLE. Psychiatric TEAE incidence was similar between patients taking ESL and placebo in the controlled and OLE study periods and was not related to ESL dose. Psychiatric TEAEs generally occurred more frequently in patients with a medical history of psychiatric disorders, using psychotropic drugs, or with depressive symptoms than in those without a history, not using psychotropic drugs, or with no depressive symptoms. Depression and anxiety were the most frequently reported psychiatric TEAEs.<\/jats:p><\/jats:sec><jats:sec><jats:title>Significance<\/jats:title><jats:p>Overall, in clinical trials of ESL in adults with focal seizures, incidences of psychiatric events were not statistically different between patients taking ESL and placebo, were not related to ESL dose, and generally occurred more frequently in patients with baseline psychiatric symptoms or a history of psychiatric disorders. Long\u2010term exposure to ESL was not associated with a marked increase in the incidence of psychiatric TEAEs.<\/jats:p><\/jats:sec>","DOI":"10.1002\/epi4.12635","type":"journal-article","created":{"date-parts":[[2022,7,31]],"date-time":"2022-07-31T13:33:26Z","timestamp":1659274406000},"page":"616-632","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Psychiatric adverse events in three phase <scp>III<\/scp> trials of eslicarbazepine acetate for focal seizures"],"prefix":"10.1002","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7154-1400","authenticated-orcid":false,"given":"Hamada","family":"Altalib","sequence":"first","affiliation":[{"name":"Department of Neurology Yale School of Medicine  New Haven Connecticut USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Todd","family":"Grinnell","sequence":"additional","affiliation":[{"name":"Sunovion Pharmaceuticals Inc.  Marlborough Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3174-0530","authenticated-orcid":false,"given":"David","family":"Cantu","sequence":"additional","affiliation":[{"name":"Sunovion Pharmaceuticals Inc.  Fort Lee New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"F\u00e1bio","family":"Ikedo","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Compliance BIAL \u2013 Portela &amp; C\u00aa, S.A.  S\u00e3o Mamede do Coronado Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mariana","family":"Vieira","sequence":"additional","affiliation":[{"name":"Pharmacovigilance Compliance BIAL \u2013 Portela &amp; C\u00aa, S.A.  S\u00e3o Mamede do Coronado Portugal"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yi","family":"Zhang","sequence":"additional","affiliation":[{"name":"Sunovion Pharmaceuticals Inc.  Marlborough Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"David","family":"Blum","sequence":"additional","affiliation":[{"name":"Sunovion Pharmaceuticals Inc.  Marlborough Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,8,30]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/epi.13766"},{"issue":"2","key":"e_1_2_12_3_1","first-page":"181","article-title":"Psychiatric effects of antiepileptic drugs in adults","volume":"16","author":"Dussaule C","year":"2018","journal-title":"Geriatr Psychol Neuropsychiatr Vieil"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.seizure.2017.04.007"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.pharep.2016.06.011"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/nrneurol.2015.243"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1474-4422(12)70153-9"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.yebeh.2019.106669"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2018.1543402"},{"key":"e_1_2_12_10_1","unstructured":"Sunovion Pharmaceuticals Inc.Aptiom\u00ae (eslicarbazepine acetate) Prescribing Information 2019. 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