Please use this identifier to cite or link to this item: https://doi.org/10.21256/zhaw-21157
Full metadata record
DC FieldValueLanguage
dc.contributor.authorHengartner, Michael Pascal-
dc.contributor.authorPlöderl, Martin-
dc.date.accessioned2021-01-06T16:05:09Z-
dc.date.available2021-01-06T16:05:09Z-
dc.date.issued2020-
dc.identifier.issn0924-6479de_CH
dc.identifier.issn1878-6847de_CH
dc.identifier.urihttps://digitalcollection.zhaw.ch/handle/11475/21157-
dc.descriptionThe final publication is available at IOS Press through http://dx.doi.org/10.3233/JRS-200033de_CH
dc.description.abstractBACKGROUND: In antidepressant trials for pediatric patients with depression or anxiety disorders, the risk of suicidal events and other severe psychiatric adverse events such as aggression and agitation is increased with antidepressants relative to placebo. OBJECTIVE: To examine whether largely mentally healthy adolescents treated for a non-psychiatric condition are also at increased risk of suicidality and other severe psychiatric disorders. METHODS: This is a re-analysis of a placebo-controlled duloxetine trial for juvenile fibromyalgia based on the main journal article and additional data published in the online supplementary material and on ClinicalTrials.gov. Both serious adverse events related to psychiatric disorders and adverse events leading to treatment discontinuation were defined as severe treatment-emergent psychiatric adverse events. RESULTS: We found that a significant portion of adolescents had treatment-emergent suicidal ideation and behaviour as well as other severe psychiatric adverse events with duloxetine, but no such events were recorded on placebo. The incidence of severe treatment emergent psychiatric adverse events was statistically significantly higher with duloxetine as compared to placebo. CONCLUSIONS: Antidepressants may put adolescents at risk of suicidality and other severe psychiatric disorders even when the treatment indication is not depression or anxiety.de_CH
dc.language.isoende_CH
dc.publisherIOS Pressde_CH
dc.relation.ispartofInternational Journal of Risk & Safety in Medicinede_CH
dc.rightsLicence according to publishing contractde_CH
dc.subjectDuloxetinede_CH
dc.subjectAntidepressantde_CH
dc.subjectRCTde_CH
dc.subjectSuicidalityde_CH
dc.subjectSuicidal ideationde_CH
dc.subjectSuicidal behaviorde_CH
dc.subjectSerious adverse eventde_CH
dc.subject.ddc615: Pharmakologie und Therapeutikde_CH
dc.titleSuicidality and other severe psychiatric events with duloxetine : re-analysis of safety data from a placebo-controlled trial for juvenile fibromyalgiade_CH
dc.typeBeitrag in wissenschaftlicher Zeitschriftde_CH
dcterms.typeTextde_CH
zhaw.departementAngewandte Psychologiede_CH
zhaw.organisationalunitPsychologisches Institut (PI)de_CH
dc.identifier.doi10.3233/JRS-200033de_CH
dc.identifier.doi10.21256/zhaw-21157-
zhaw.funding.euNode_CH
zhaw.originated.zhawYesde_CH
zhaw.publication.statusacceptedVersionde_CH
zhaw.publication.reviewPeer review (Publikation)de_CH
zhaw.webfeedKlinische Psychologiede_CH
zhaw.author.additionalNode_CH
zhaw.display.portraitYesde_CH
Appears in collections:Publikationen Angewandte Psychologie

Files in This Item:
File Description SizeFormat 
2020_Hengartner-Ploederl_Duloxetine-Severe-Psychiatric-AE.pdfAccepted Version263.29 kBAdobe PDFThumbnail
View/Open


Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.