{"id":"https://openalex.org/W4367054142","doi":"https://doi.org/10.1017/s0033291723001058","title":"Reporting of harms in clinical trials of esketamine in depression: a systematic review","display_name":"Reporting of harms in clinical trials of esketamine in depression: a systematic review","publication_year":2023,"publication_date":"2023-04-26","ids":{"openalex":"https://openalex.org/W4367054142","doi":"https://doi.org/10.1017/s0033291723001058","pmid":"https://pubmed.ncbi.nlm.nih.gov/37185130"},"language":"en","primary_location":{"id":"doi:10.1017/s0033291723001058","doi":"https://doi.org/10.1017/s0033291723001058","is_oa":false,"landing_page_url":"https://doi.org/10.1017/s0033291723001058","pdf_url":null,"source":{"id":"https://openalex.org/S71144982","display_name":"Psychological Medicine","issn_l":"0033-2917","issn":["0033-2917","1469-8978"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","erih-plus","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310311721","host_organization_name":"Cambridge University Press","host_organization_lineage":["https://openalex.org/P4310311721","https://openalex.org/P4310311702"],"host_organization_lineage_names":["Cambridge University Press","University of Cambridge"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Psychological Medicine","raw_type":"journal-article"},"volume":null,"type":"review","indexed_in":["crossref","pubmed"],"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/A5060119803","display_name":"Tanguy Taillefer de Laportali\u00e8re","orcid":"https://orcid.org/0000-0002-0173-6437","observed_orcids":["https://orcid.org/0000-0002-0173-6437"]},"institutions":[{"id":"https://openalex.org/I3019448017","display_name":"Centre Hospitalier Universitaire de Toulouse","ror":"https://ror.org/017h5q109","country_code":"FR","type":"healthcare","lineage":["https://openalex.org/I3019448017"]}],"countries":["FR"],"is_corresponding":true,"raw_author_name":"Tanguy Taillefer de Laportali\u00e8re","raw_affiliation_strings":["Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France"],"raw_orcid":"https://orcid.org/0000-0002-0173-6437","affiliations":[{"raw_affiliation_string":"Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France","institution_ids":["https://openalex.org/I3019448017"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5048366752","display_name":"Adeline Jullien","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I3019448017","display_name":"Centre Hospitalier Universitaire de Toulouse","ror":"https://ror.org/017h5q109","country_code":"FR","type":"healthcare","lineage":["https://openalex.org/I3019448017"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Adeline Jullien","raw_affiliation_strings":["Department of Pharmacy, Toulouse University Hospital (CHU), Toulouse, France"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmacy, Toulouse University Hospital (CHU), Toulouse, France","institution_ids":["https://openalex.org/I3019448017"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5061847667","display_name":"Antoine Yrondi","orcid":"https://orcid.org/0000-0002-2650-6080","observed_orcids":["https://orcid.org/0000-0002-2650-6080"]},"institutions":[{"id":"https://openalex.org/I134560555","display_name":"Universit\u00e9 Toulouse III - Paul Sabatier","ror":"https://ror.org/02v6kpv12","country_code":"FR","type":"education","lineage":["https://openalex.org/I134560555","https://openalex.org/I4405258862"]},{"id":"https://openalex.org/I154526488","display_name":"Inserm","ror":"https://ror.org/02vjkv261","country_code":"FR","type":"government","lineage":["https://openalex.org/I154526488"]},{"id":"https://openalex.org/I3019448017","display_name":"Centre Hospitalier Universitaire de Toulouse","ror":"https://ror.org/017h5q109","country_code":"FR","type":"healthcare","lineage":["https://openalex.org/I3019448017"]},{"id":"https://openalex.org/I4210096842","display_name":"Fondation FondaMental","ror":"https://ror.org/00rrhf939","country_code":"FR","type":"other","lineage":["https://openalex.org/I4210096842"]},{"id":"https://openalex.org/I4405264399","display_name":"Toulouse NeuroImaging Center","ror":"https://ror.org/01t1x3s61","country_code":"FR","type":"facility","lineage":["https://openalex.org/I154526488","https://openalex.org/I4405258862","https://openalex.org/I4405264399"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Antoine Yrondi","raw_affiliation_strings":["Department of Medical Psychiatry, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France","ToNIC Toulouse NeuroImaging Center, University Paul Sabatier Toulouse, INSERM, Toulouse, France","Treatment Resistant Depression Expert Center, FondaMental, Toulouse, France"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Medical Psychiatry, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France","institution_ids":["https://openalex.org/I3019448017"]},{"raw_affiliation_string":"ToNIC Toulouse NeuroImaging Center, University Paul Sabatier Toulouse, INSERM, Toulouse, France","institution_ids":["https://openalex.org/I134560555","https://openalex.org/I154526488","https://openalex.org/I4405264399"]},{"raw_affiliation_string":"Treatment Resistant Depression Expert Center, FondaMental, Toulouse, France","institution_ids":["https://openalex.org/I4210096842"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5021315512","display_name":"Philippe Cestac","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I3019448017","display_name":"Centre Hospitalier Universitaire de Toulouse","ror":"https://ror.org/017h5q109","country_code":"FR","type":"healthcare","lineage":["https://openalex.org/I3019448017"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Philippe Cestac","raw_affiliation_strings":["Department of Pharmacy, Toulouse University Hospital (CHU), Toulouse, France"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmacy, Toulouse University Hospital (CHU), Toulouse, France","institution_ids":["https://openalex.org/I3019448017"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5027339862","display_name":"Fran\u00e7ois Montastruc","orcid":"https://orcid.org/0000-0001-7056-8126","observed_orcids":["https://orcid.org/0000-0001-7056-8126"]},"institutions":[{"id":"https://openalex.org/I3019448017","display_name":"Centre Hospitalier Universitaire de Toulouse","ror":"https://ror.org/017h5q109","country_code":"FR","type":"healthcare","lineage":["https://openalex.org/I3019448017"]},{"id":"https://openalex.org/I4387156050","display_name":"Centre d\u2019Investigation Clinique 1436","ror":"https://ror.org/033z83z59","country_code":"FR","type":"facility","lineage":["https://openalex.org/I154526488","https://openalex.org/I3019448017","https://openalex.org/I4387156050","https://openalex.org/I4405258862"]}],"countries":["FR"],"is_corresponding":false,"raw_author_name":"Fran\u00e7ois Montastruc","raw_affiliation_strings":["Centre d'Investigation Clinique 1436, Team PEPSS 'Pharmacologie En Population cohorteS et biobanqueS', Toulouse University Hospital, France","Department of Medical Psychiatry, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France","Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France"],"raw_orcid":"https://orcid.org/0000-0001-7056-8126","affiliations":[{"raw_affiliation_string":"Centre d'Investigation Clinique 1436, Team PEPSS 'Pharmacologie En Population cohorteS et biobanqueS', Toulouse University Hospital, France","institution_ids":["https://openalex.org/I4387156050"]},{"raw_affiliation_string":"Department of Medical Psychiatry, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France","institution_ids":["https://openalex.org/I3019448017"]},{"raw_affiliation_string":"Department of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Toulouse University Hospital (CHU), Faculty of Medicine, Toulouse, France","institution_ids":["https://openalex.org/I3019448017"]}]}],"institutions":[],"countries_distinct_count":1,"institutions_distinct_count":6,"corresponding_author_ids":["https://openalex.org/A5060119803"],"corresponding_institution_ids":["https://openalex.org/I3019448017"],"apc_list":{"value":3255,"currency":"USD","value_usd":3255},"apc_paid":null,"fwci":3.5983,"has_fulltext":false,"cited_by_count":51,"citation_normalized_percentile":{"value":0.9471243,"is_in_top_1_percent":false,"is_in_top_10_percent":true},"cited_by_percentile_year":{"min":99,"max":100},"biblio":{"volume":"53","issue":"10","first_page":"4305","last_page":"4315"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T10206","display_name":"Meta-analysis and systematic reviews","score":0.40720000863075256,"subfield":{"id":"https://openalex.org/subfields/1804","display_name":"Statistics, Probability and Uncertainty"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},"topics":[{"id":"https://openalex.org/T10206","display_name":"Meta-analysis and systematic reviews","score":0.40720000863075256,"subfield":{"id":"https://openalex.org/subfields/1804","display_name":"Statistics, Probability and Uncertainty"},"field":{"id":"https://openalex.org/fields/18","display_name":"Decision Sciences"},"domain":{"id":"https://openalex.org/domains/2","display_name":"Social Sciences"}},{"id":"https://openalex.org/T11071","display_name":"Treatment of Major Depression","score":0.37790000438690186,"subfield":{"id":"https://openalex.org/subfields/2736","display_name":"Pharmacology"},"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/T11649","display_name":"Pharmaceutical industry and healthcare","score":0.07010000199079514,"subfield":{"id":"https://openalex.org/subfields/3004","display_name":"Pharmacology"},"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/esketamine","display_name":"esketamine","score":1.0},{"id":"https://openalex.org/keywords/treatment-resistant-depression","display_name":"treatment-resistant depression","score":0.8500000238418579},{"id":"https://openalex.org/keywords/adverse-event-reporting","display_name":"adverse event reporting","score":0.9639999866485596},{"id":"https://openalex.org/keywords/harms-reporting","display_name":"harms reporting","score":0.578000009059906},{"id":"https://openalex.org/keywords/reporting-quality","display_name":"reporting quality","score":0.734000027179718},{"id":"https://openalex.org/keywords/clinicaltrials-gov","display_name":"ClinicalTrials.gov","score":0.925000011920929},{"id":"https://openalex.org/keywords/serious-adverse-events","display_name":"serious adverse events","score":0.8230000138282776},{"id":"https://openalex.org/keywords/psychiatric-adverse-events","display_name":"psychiatric adverse events","score":0.8500000238418579},{"id":"https://openalex.org/keywords/adverse-cardiovascular-events","display_name":"cardiovascular adverse events","score":0.9490000009536743}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.7767651677131653},{"id":"https://openalex.org/C49290038","wikidata":"https://www.wikidata.org/wiki/Q2994654","display_name":"Consolidated Standards of Reporting Trials","level":3,"score":0.7009000182151794},{"id":"https://openalex.org/C535046627","wikidata":"https://www.wikidata.org/wiki/Q30612","display_name":"Clinical trial","level":2,"score":0.6592943668365479},{"id":"https://openalex.org/C2779356329","wikidata":"https://www.wikidata.org/wiki/Q922625","display_name":"Checklist","level":2,"score":0.6512051820755005},{"id":"https://openalex.org/C2779473830","wikidata":"https://www.wikidata.org/wiki/Q1540899","display_name":"MEDLINE","level":2,"score":0.5338322520256042},{"id":"https://openalex.org/C197934379","wikidata":"https://www.wikidata.org/wiki/Q2047938","display_name":"Adverse effect","level":2,"score":0.5305690765380859},{"id":"https://openalex.org/C2776867660","wikidata":"https://www.wikidata.org/wiki/Q1814941","display_name":"Depression (economics)","level":2,"score":0.5059232115745544},{"id":"https://openalex.org/C136206449","wikidata":"https://www.wikidata.org/wiki/Q3556841","display_name":"Reporting bias","level":3,"score":0.44653642177581787},{"id":"https://openalex.org/C189708586","wikidata":"https://www.wikidata.org/wiki/Q1504425","display_name":"Systematic review","level":3,"score":0.42582884430885315},{"id":"https://openalex.org/C118552586","wikidata":"https://www.wikidata.org/wiki/Q7867","display_name":"Psychiatry","level":1,"score":0.32435786724090576},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.30800890922546387},{"id":"https://openalex.org/C15744967","wikidata":"https://www.wikidata.org/wiki/Q9418","display_name":"Psychology","level":0,"score":0.14834347367286682},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.0},{"id":"https://openalex.org/C180747234","wikidata":"https://www.wikidata.org/wiki/Q23373","display_name":"Cognitive psychology","level":1,"score":0.0},{"id":"https://openalex.org/C139719470","wikidata":"https://www.wikidata.org/wiki/Q39680","display_name":"Macroeconomics","level":1,"score":0.0},{"id":"https://openalex.org/C162324750","wikidata":"https://www.wikidata.org/wiki/Q8134","display_name":"Economics","level":0,"score":0.0},{"id":"https://openalex.org/C199539241","wikidata":"https://www.wikidata.org/wiki/Q7748","display_name":"Law","level":1,"score":0.0}],"mesh":[{"descriptor_ui":"D000928","descriptor_name":"Antidepressive Agents","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":true},{"descriptor_ui":"D002986","descriptor_name":"Clinical Trials as Topic","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D003863","descriptor_name":"Depression","qualifier_ui":"Q000188","qualifier_name":"drug therapy","is_major_topic":true},{"descriptor_ui":"D006801","descriptor_name":"Humans","qualifier_ui":null,"qualifier_name":null,"is_major_topic":false},{"descriptor_ui":"D007649","descriptor_name":"Ketamine","qualifier_ui":"Q000009","qualifier_name":"adverse effects","is_major_topic":true}],"locations_count":3,"locations":[{"id":"doi:10.1017/s0033291723001058","doi":"https://doi.org/10.1017/s0033291723001058","is_oa":false,"landing_page_url":"https://doi.org/10.1017/s0033291723001058","pdf_url":null,"source":{"id":"https://openalex.org/S71144982","display_name":"Psychological Medicine","issn_l":"0033-2917","issn":["0033-2917","1469-8978"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-a","doyens","erih-plus","jufo-3","ki-jl-2","medline","norway-2","poland-140","russia-white-list-1","vabb-shw"],"host_organization":"https://openalex.org/P4310311721","host_organization_name":"Cambridge University Press","host_organization_lineage":["https://openalex.org/P4310311721","https://openalex.org/P4310311702"],"host_organization_lineage_names":["Cambridge University Press","University of Cambridge"],"type":"journal"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Psychological Medicine","raw_type":"journal-article"},{"id":"pmid:37185130","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/37185130","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Psychological medicine","raw_type":"Journal Article"},{"id":"pmh:oai:HAL:hal-04934843v1","doi":null,"is_oa":false,"landing_page_url":"https://hal.science/hal-04934843","pdf_url":null,"source":{"id":"https://openalex.org/S4306402512","display_name":"HAL","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I4405252976","host_organization_name":"Centre pour la Communication Scientifique Directe","host_organization_lineage":["https://openalex.org/I4405252976"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"submittedVersion","is_accepted":false,"is_published":false,"raw_source_name":"Psychological Medicine, 2023, 53 (10), pp.4305-4315. ⟨10.1017/S0033291723001058⟩","raw_type":"info:eu-repo/semantics/article"}],"best_oa_location":null,"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.9940000176429749,"id":"https://metadata.un.org/sdg/3"}],"study_designs":[{"display_name":"Systematic Review","id":"https://openalex.org/study-designs/systematic-review"}],"awards":[],"funders":[],"has_content":{"grobid_xml":false,"pdf":false},"content_urls":null,"referenced_works_count":28,"referenced_works":["https://openalex.org/W1747918244","https://openalex.org/W1986360186","https://openalex.org/W2000034135","https://openalex.org/W2089799205","https://openalex.org/W2263572070","https://openalex.org/W2481029616","https://openalex.org/W2531269403","https://openalex.org/W2779386549","https://openalex.org/W2796940952","https://openalex.org/W2946661342","https://openalex.org/W2948816951","https://openalex.org/W2961020354","https://openalex.org/W2970684805","https://openalex.org/W2981272605","https://openalex.org/W2982430136","https://openalex.org/W2982569821","https://openalex.org/W2983463140","https://openalex.org/W2990600117","https://openalex.org/W3017383621","https://openalex.org/W3025905746","https://openalex.org/W3030344574","https://openalex.org/W3082360571","https://openalex.org/W3082490768","https://openalex.org/W3088002975","https://openalex.org/W3090435879","https://openalex.org/W3198178298","https://openalex.org/W3208279447","https://openalex.org/W4213300280"],"related_works":["https://openalex.org/W4386084443","https://openalex.org/W3082360571","https://openalex.org/W4399690209","https://openalex.org/W4225815697","https://openalex.org/W6924994425","https://openalex.org/W4213364975","https://openalex.org/W2153458728","https://openalex.org/W2518292922","https://openalex.org/W7162966838","https://openalex.org/W4389828495"],"abstract_inverted_index":{"While":[0],"previous":[1],"systematic":[2],"reviews":[3],"of":[4,29,36,53,73,85,98,159,164,193,200,223,227,246],"trials":[5,43,67,125,132,199],"evaluating":[6,68],"conventional":[7],"antidepressants":[8],"highlighted":[9],"inadequacies":[10],"and":[11,71,81,119,162,185,204,244],"inconsistencies":[12],"in":[13,24,39,56,62,75,128,153,170,196,210,214,234],"adverse":[14],"event":[15],"(AE)":[16],"reporting,":[17],"no":[18],"evaluation":[19],"is":[20,237],"available":[21],"on":[22,230],"esketamine":[23,74,190,201,228],"resistant":[25],"depression.":[26],"The":[27,83,104,217],"objective":[28],"this":[30],"review":[31],"was":[32,88,108,144,202],"to":[33,49,59,140,150,240],"assess":[34],"quality":[35,84,106],"reporting":[37,86,195],"AEs":[38,54,151,161,166,194],"all":[40],"published":[41,172,197],"clinical":[42,124,198],"studying":[44],"esketamine.":[45],"It":[46],"also":[47,182],"aimed":[48],"compare":[50],"the":[51,63,69,95,129,171,176,224,231,241],"proportions":[52],"reported":[55,169,207,233],"journal":[57,211],"articles":[58],"those":[60],"recorded":[61,152],"ClinicalTrial.gov":[64,215],"Registers.":[65,216],"Clinical":[66],"efficacy":[70],"safety":[72],"depression":[76],"were":[77,126,133,167,178,206],"searched":[78],"using":[79,90],"Medline":[80],"ClinicalTrials.gov.":[82],"harms":[87,205],"assessed":[89],"a":[91],"21-item":[92],"checklist":[93],"from":[94,189],"CONSORT":[96],"Extension":[97],"Harms":[99],"(1":[100],"point":[101],"by":[102],"item).":[103],"total":[105],"score":[107],"graded":[109],"into":[110],"four":[111],"categories:":[112],"high":[113],"(17-21),":[114],"moderate":[115],"(12-16),":[116],"low":[117,121],"(7-11)":[118],"very":[120],"(0-6).":[122],"Ten":[123],"included":[127],"analysis.":[130],"Nine":[131],"classified":[134,145],"as":[135,146],"'low":[136],"quality'":[137],"with":[138],"regard":[139],"safety,":[141],"one":[142],"trial":[143,235],"'moderate":[147],"quality'.":[148],"Compared":[149],"ClinicalTrials.gov,":[154],"we":[155],"found":[156],"that":[157,220],"41.5%":[158],"serious":[160],"39%":[163],"non-serious":[165],"not":[168],"articles.":[173],"Among":[174],"them,":[175],"majority":[177],"psychiatric":[179],"events":[180,184],"but":[181],"cardiovascular":[183],"94%":[186],"concerned":[187],"patients":[188],"groups.":[191],"Quality":[192],"poor":[203,242],"less":[208],"frequently":[209],"publications":[212,236],"than":[213],"study":[218],"suggests":[219],"an":[221],"assessment":[222],"benefits/risks":[225],"balance":[226],"based":[229],"results":[232],"flawed":[238],"due":[239],"accuracy":[243],"completeness":[245],"harm":[247],"data.":[248]},"counts_by_year":[{"year":2026,"cited_by_count":7},{"year":2025,"cited_by_count":11},{"year":2024,"cited_by_count":24},{"year":2023,"cited_by_count":9}],"updated_date":"2026-10-31T12:09:11.096373","created_date":"2023-04-27T00:00:00"}