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Publication type: Article in scientific journal
Type of review: Peer review (publication)
Title: Suicidality and other severe psychiatric events with duloxetine : re-analysis of safety data from a placebo-controlled trial for juvenile fibromyalgia
Authors: Hengartner, Michael Pascal
Plöderl, Martin
et. al: No
DOI: 10.3233/JRS-200033
Published in: International Journal of Risk & Safety in Medicine
Issue Date: 2020
Publisher / Ed. Institution: IOS Press
ISSN: 0924-6479
Language: English
Subjects: Duloxetine; Antidepressant; RCT; Suicidality; Suicidal ideation; Suicidal behavior; Serious adverse event
Subject (DDC): 615: Pharmacology and therapeutics
Abstract: BACKGROUND: 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 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.
Further description: The final publication is available at IOS Press through
Fulltext version: Accepted version
License (according to publishing contract): Licence according to publishing contract
Departement: Applied Psychology
Organisational Unit: Psychological Institute (PI)
Appears in collections:Publikationen Angewandte Psychologie

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