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https://doi.org/10.21256/zhaw-21157| 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 10.21256/zhaw-21157 |
| Published in: | International Journal of Risk & Safety in Medicine |
| Volume(Issue): | 32 |
| Issue: | 3 |
| Page(s): | 209 |
| Pages to: | 218 |
| Issue Date: | 2021 |
| Publisher / Ed. Institution: | IOS Press |
| ISSN: | 0924-6479 1878-6847 |
| 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 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. |
| Further description: | The final publication is available at IOS Press through http://dx.doi.org/10.3233/JRS-200033 |
| URI: | https://digitalcollection.zhaw.ch/handle/11475/21157 |
| 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 |
Files in This Item:
| File | Description | Size | Format | |
|---|---|---|---|---|
| 2020_Hengartner-Ploederl_Duloxetine-Severe-Psychiatric-AE.pdf | Accepted Version | 263.29 kB | Adobe PDF |  View/Open |
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Hengartner, M. P., & Plöderl, M. (2021). Suicidality and other severe psychiatric events with duloxetine : re-analysis of safety data from a placebo-controlled trial for juvenile fibromyalgia. International Journal of Risk & Safety in Medicine, 32(3), 209–218. https://doi.org/10.3233/JRS-200033
Hengartner, M.P. and Plöderl, M. (2021) ‘Suicidality and other severe psychiatric events with duloxetine : re-analysis of safety data from a placebo-controlled trial for juvenile fibromyalgia’, International Journal of Risk & Safety in Medicine, 32(3), pp. 209–218. Available at: https://doi.org/10.3233/JRS-200033.
M. P. Hengartner and M. Plöderl, “Suicidality and other severe psychiatric events with duloxetine : re-analysis of safety data from a placebo-controlled trial for juvenile fibromyalgia,” International Journal of Risk & Safety in Medicine, vol. 32, no. 3, pp. 209–218, 2021, doi: 10.3233/JRS-200033.
HENGARTNER, Michael Pascal und Martin PLÖDERL, 2021. Suicidality and other severe psychiatric events with duloxetine : re-analysis of safety data from a placebo-controlled trial for juvenile fibromyalgia. International Journal of Risk & Safety in Medicine. 2021. Bd. 32, Nr. 3, S. 209–218. DOI 10.3233/JRS-200033
Hengartner, Michael Pascal, and Martin Plöderl. 2021. “Suicidality and Other Severe Psychiatric Events with Duloxetine : Re-Analysis of Safety Data from a Placebo-Controlled Trial for Juvenile Fibromyalgia.” International Journal of Risk & Safety in Medicine 32 (3): 209–18. https://doi.org/10.3233/JRS-200033.
Hengartner, Michael Pascal, and Martin Plöderl. “Suicidality and Other Severe Psychiatric Events with Duloxetine : Re-Analysis of Safety Data from a Placebo-Controlled Trial for Juvenile Fibromyalgia.” International Journal of Risk & Safety in Medicine, vol. 32, no. 3, 2021, pp. 209–18, https://doi.org/10.3233/JRS-200033.
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