{"id":"https://openalex.org/W3215703293","doi":"https://doi.org/10.1212/wnl.88.16_supplement.p3.243","title":"Relationship between Adjunctive Eslicarbazepine Acetate (ESL) Use and Incidence of Psychiatric Adverse Events in Patients Taking Psychotropic Drugs in Three Phase III ESL Trials (P3.243)","display_name":"Relationship between Adjunctive Eslicarbazepine Acetate (ESL) Use and Incidence of Psychiatric Adverse Events in Patients Taking Psychotropic Drugs in Three Phase III ESL Trials (P3.243)","publication_year":2017,"publication_date":"2017-04-18","ids":{"openalex":"https://openalex.org/W3215703293","doi":"https://doi.org/10.1212/wnl.88.16_supplement.p3.243","mag":"3215703293"},"language":"en","primary_location":{"id":"doi:10.1212/wnl.88.16_supplement.p3.243","doi":"https://doi.org/10.1212/wnl.88.16_supplement.p3.243","is_oa":false,"landing_page_url":"https://doi.org/10.1212/wnl.88.16_supplement.p3.243","pdf_url":null,"source":{"id":"https://openalex.org/S79704628","display_name":"Neurology","issn_l":"0028-3878","issn":["0028-3878","1526-632X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Neurology","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5080677331","display_name":"Cynthia L. Harden","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I1287643137","display_name":"Mount Sinai Beth Israel","ror":"https://ror.org/01742jq13","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I1287643137","https://openalex.org/I1320796813"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Cynthia Harden","raw_affiliation_strings":["Mount Sinai Beth Israel PACC New York NY United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Mount Sinai Beth Israel PACC New York NY United States","institution_ids":["https://openalex.org/I1287643137"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5008098418","display_name":"Mar Carre\u00f1o","orcid":"https://orcid.org/0000-0001-9347-275X","observed_orcids":["https://orcid.org/0000-0001-9347-275X","https://orcid.org/0000-0002-3361-8427"]},"institutions":[{"id":"https://openalex.org/I4210115097","display_name":"Hospital Cl\u00ednic de Barcelona","ror":"https://ror.org/02a2kzf50","country_code":"ES","type":"healthcare","lineage":["https://openalex.org/I4210115097"]}],"countries":["ES"],"is_corresponding":false,"raw_author_name":"Mar Carre\u00f1o","raw_affiliation_strings":["Epilepsy Unit, Hospital Cl\u00ednic Barcelona Spain"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Epilepsy Unit, Hospital Cl\u00ednic Barcelona Spain","institution_ids":["https://openalex.org/I4210115097"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5110581567","display_name":"Helena Gama","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I108511484","display_name":"Bial (Portugal)","ror":"https://ror.org/02htdjb57","country_code":"PT","type":"company","lineage":["https://openalex.org/I108511484"]}],"countries":["PT"],"is_corresponding":false,"raw_author_name":"Helena Gama","raw_affiliation_strings":["BIAL \u2013 Portela & C\u00aa, S.A. S. Mamede do Coronado Portugal"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"BIAL \u2013 Portela & C\u00aa, S.A. S. Mamede do Coronado Portugal","institution_ids":["https://openalex.org/I108511484"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5078712323","display_name":"Patr\u0131\u0301cio Soares-da-Silva","orcid":"https://orcid.org/0000-0002-2446-5078","observed_orcids":["https://orcid.org/0000-0002-2446-5078"]},"institutions":[{"id":"https://openalex.org/I108511484","display_name":"Bial (Portugal)","ror":"https://ror.org/02htdjb57","country_code":"PT","type":"company","lineage":["https://openalex.org/I108511484"]}],"countries":["PT"],"is_corresponding":false,"raw_author_name":"Patr\u00edcio Soares-da-Silva","raw_affiliation_strings":["BIAL \u2013 Portela & C\u00aa, S.A. S. Mamede do Coronado Portugal"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"BIAL \u2013 Portela & C\u00aa, S.A. S. Mamede do Coronado Portugal","institution_ids":["https://openalex.org/I108511484"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5014901271","display_name":"JungAh Jung","orcid":"https://orcid.org/0000-0002-2990-2070","observed_orcids":["https://orcid.org/0000-0002-2990-2070"]},"institutions":[{"id":"https://openalex.org/I4210122020","display_name":"Sunovion (United States)","ror":"https://ror.org/030zc7t66","country_code":"US","type":"company","lineage":["https://openalex.org/I4210122020"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"JungAh Jung","raw_affiliation_strings":["Sunovion Pharmaceuticals Inc. Marlborough MA United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Sunovion Pharmaceuticals Inc. Marlborough MA United States","institution_ids":["https://openalex.org/I4210122020"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5084941652","display_name":"Todd Grinnell","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210122020","display_name":"Sunovion (United States)","ror":"https://ror.org/030zc7t66","country_code":"US","type":"company","lineage":["https://openalex.org/I4210122020"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Todd Grinnell","raw_affiliation_strings":["Sunovion Pharmaceuticals Inc. Marlborough MA United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Sunovion Pharmaceuticals Inc. Marlborough MA United States","institution_ids":["https://openalex.org/I4210122020"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5103238393","display_name":"David E. Blum","orcid":"https://orcid.org/0000-0002-1150-8331","observed_orcids":["https://orcid.org/0000-0002-1150-8331"]},"institutions":[{"id":"https://openalex.org/I4210122020","display_name":"Sunovion (United States)","ror":"https://ror.org/030zc7t66","country_code":"US","type":"company","lineage":["https://openalex.org/I4210122020"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"David Blum","raw_affiliation_strings":["Sunovion Pharmaceuticals Inc. Marlborough MA United States"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Sunovion Pharmaceuticals Inc. Marlborough MA United States","institution_ids":["https://openalex.org/I4210122020"]}]}],"institutions":[],"countries_distinct_count":3,"institutions_distinct_count":4,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.44145012,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"88","issue":"16_supplement","first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10094","display_name":"Epilepsy research and treatment","score":0.9707000255584717,"subfield":{"id":"https://openalex.org/subfields/2738","display_name":"Psychiatry and Mental health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T10094","display_name":"Epilepsy research and treatment","score":0.9707000255584717,"subfield":{"id":"https://openalex.org/subfields/2738","display_name":"Psychiatry and Mental health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T12229","display_name":"Pharmacological Effects and Toxicity Studies","score":0.0044999998062849045,"subfield":{"id":"https://openalex.org/subfields/2735","display_name":"Pediatrics, Perinatology and Child Health"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.004100000020116568,"subfield":{"id":"https://openalex.org/subfields/3005","display_name":"Toxicology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/eslicarbazepine-acetate","display_name":"eslicarbazepine acetate","score":0.9950000047683716},{"id":"https://openalex.org/keywords/psychiatric-adverse-events","display_name":"psychiatric adverse events","score":0.8700000047683716},{"id":"https://openalex.org/keywords/psychotropic-drugs","display_name":"psychotropic drugs","score":0.8289999961853027},{"id":"https://openalex.org/keywords/adjunctive-antiepileptic-therapy","display_name":"adjunctive antiepileptic therapy","score":0.8859999775886536},{"id":"https://openalex.org/keywords/adverse-drug-reactions","display_name":"adverse drug reactions","score":0.5590000152587891},{"id":"https://openalex.org/keywords/epilepsy","display_name":"epilepsy","score":0.40400001406669617}],"concepts":[{"id":"https://openalex.org/C61511704","wikidata":"https://www.wikidata.org/wiki/Q1671857","display_name":"Incidence (geometry)","level":2,"score":0.697791337966919},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.6097887754440308},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.5642954707145691},{"id":"https://openalex.org/C118552586","wikidata":"https://www.wikidata.org/wiki/Q7867","display_name":"Psychiatry","level":1,"score":0.4992842674255371},{"id":"https://openalex.org/C187212893","wikidata":"https://www.wikidata.org/wiki/Q123028","display_name":"Pediatrics","level":1,"score":0.38577795028686523},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.32380300760269165},{"id":"https://openalex.org/C121332964","wikidata":"https://www.wikidata.org/wiki/Q413","display_name":"Physics","level":0,"score":0.0},{"id":"https://openalex.org/C120665830","wikidata":"https://www.wikidata.org/wiki/Q14620","display_name":"Optics","level":1,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1212/wnl.88.16_supplement.p3.243","doi":"https://doi.org/10.1212/wnl.88.16_supplement.p3.243","is_oa":false,"landing_page_url":"https://doi.org/10.1212/wnl.88.16_supplement.p3.243","pdf_url":null,"source":{"id":"https://openalex.org/S79704628","display_name":"Neurology","issn_l":"0028-3878","issn":["0028-3878","1526-632X"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310315671","host_organization_name":"Lippincott Williams & Wilkins","host_organization_lineage":["https://openalex.org/P4310315671","https://openalex.org/P4310318547"],"host_organization_lineage_names":["Lippincott Williams & Wilkins","Wolters Kluwer"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Neurology","raw_type":"journal-article"}],"best_oa_location":null,"sustainable_development_goals":[{"score":1.0,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"sustainable_development_goals_aurora":[{"score":0.8100000023841858,"display_name":"Good health and well-being","id":"https://metadata.un.org/sdg/3"}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W4389449912","https://openalex.org/W4288968146","https://openalex.org/W2794846120","https://openalex.org/W2806568072","https://openalex.org/W4389441721","https://openalex.org/W2040973717","https://openalex.org/W75723327","https://openalex.org/W2889051287","https://openalex.org/W2793079292","https://openalex.org/W2578414214"],"abstract_inverted_index":{"Objective:":[0],"To":[1],"evaluate":[2],"the":[3,34,48,151,170,178,186,204,240],"potential":[4,49],"relationship":[5],"between":[6,177,185,203,249],"ESL":[7,29,78,94,173,207,227,232,252],"use":[8,120,125,289],"and":[9,81,99,123,172,180,184,188,195,206,211,308,322,331,335],"incidence":[10,218,268],"of":[11,33,38,52,61,68,76,110,121,126,163,198,242,269,290,327,341],"\u2018psychiatric\u2019":[12,114],"adverse":[13],"events":[14],"(AEs)":[15],"in":[16,83,150,169,239,272],"patients":[17,84,149,164,220,250,273],"taking":[18,251,260],"concomitant":[19,119,288],"medications":[20],"with":[21,85,128,165,214,276,318,356,373,388,402],"putative":[22,129,277],"beneficial":[23,130,278],"or":[24,104,135,139,245,253,256,279],"detrimental":[25,140,280],"psychotropic":[26,57,143,262,281],"effects.":[27,144],"Background:":[28],"(and":[30],"other":[31],"members":[32],"dibenzazepine":[35],"carboxamide":[36],"class":[37,54],"antiepileptic":[39],"drugs":[40,263],"[AEDs])":[41],"are":[42],"structurally":[43],"related":[44],"to":[45,55,118],"tricyclic":[46],"antidepressants;":[47],"for":[50,193,209,316,354,371,386,400],"AEDs":[51,127],"this":[53],"have":[56],"effects":[58,282],"is":[59],"therefore":[60],"interest.":[62],"Design/Methods:":[63],"An":[64],"exploratory":[65],"post-hoc":[66],"analysis":[67],"data":[69],"pooled":[70],"from":[71,306,332],"three":[72],"Phase":[73],"III":[74],"studies":[75],"adjunctive":[77,291],"(BIA-2093-301,":[79],"\u2212302":[80],"\u2212304)":[82],"treatment-refractory":[86],"partial-onset":[87],"seizures":[88],"was":[89,201,283],"conducted.":[90],"Patients":[91],"received":[92,303,313,351,368,383,397],"placebo,":[93,254],"400":[95],"mg":[96,106],"(studies":[97],"301":[98],"302":[100],"only),":[101],"800":[102],"mg,":[103],"1200":[105],"once":[107],"daily.":[108],"Reports":[109],"AEs":[111,200,248,271],"classed":[112],"as":[113,324,337,362,377,391,406],"were":[115,147,175,235,259],"evaluated":[116],"according":[117],"antidepressants,":[122,213],"baseline":[124],"(carbamazepine":[131],"[CBZ],":[132],"lamotrigine":[133],"[LTG]":[134],"valproic":[136],"acid":[137],"[VPA])":[138],"(levetiracetam":[141],"[LEV])":[142],"Results:":[145],"There":[146,234],"1447":[148],"safety":[152],"population":[153],"(placebo,":[154],"n":[155,159],"=":[156,160],"426;":[157],"ESL,":[158],"1021).":[161],"Proportions":[162],"\u2018any":[166],"psychiatric":[167,199,247,270],"AE\u2019":[168],"placebo":[171,205,225,230],"groups":[174,208],"comparable":[176,202],"+":[179,187,210],"\u2212":[181,189,212],"CBZ/LTG/VPA":[182],"groups,":[183],"LEV":[190],"groups;":[191],"similarly":[192],"\u2018depression\u2019":[194],"\u2018anxiety\u2019.":[196],"Incidence":[197],"a":[215,325,338],"greater":[216],"overall":[217],"among":[219],"using":[221,274],"antidepressants":[222],"(+":[223],"antidepressants:":[224],"25.0%,":[226],"23.6%;":[228],"-antidepressants:":[229],"9.1%,":[231],"9.2%).":[233],"no":[236],"notable":[237],"differences":[238],"incidences":[241],"mild,":[243],"moderate":[244],"severe":[246],"whether":[255],"not":[257,284],"they":[258],"different":[261],"at":[264],"baseline.":[265],"Conclusions:":[266],"The":[267],"agents":[275],"notably":[285],"influenced":[286],"by":[287],"ESL.":[292],"Study":[293],"Supported":[294],"by:":[295],"Sunovion":[296,374,389,403],"Pharmaceuticals":[297,375,390,404],"Inc.":[298,376,405],"Disclosure:":[299],"Dr.":[300,310,348,365,380,394],"Harden":[301],"has":[302,312,350,367,382,396],"royalty":[304],"payments":[305],"Wiley":[307],"Up-to-date.":[309],"Carreno":[311],"personal":[314,352,369,384,398],"compensation":[315,353,370,385,399],"activities":[317,355,372,387,401],"UCB":[319],"Pharma,":[320],"Eisai,":[321,333],"BIAL":[323,342],"member":[326],"an":[328,363,378,392,407],"advisory":[329],"board":[330],"BIAL,":[334],"Esteve":[336],"speaker.":[339],"Employee":[340],"-":[343],"Portela":[344,358],"&":[345,359],"C\u00aa,":[346],"S.A.":[347],"Soares-da-Silva":[349],"Bial-":[357],"C\u00aa":[360],"S.A":[361],"employee.":[364,379,393,408],"Jung":[366],"Grinnell":[381],"Blum":[395]},"counts_by_year":[],"updated_date":"2026-10-26T11:51:55.731654","created_date":"2021-12-06T00:00:00"}