Koerhuis, Sanne (2022) Bias in Onderzoek naar de Veiligheid van Antidepressiva voor Depressie bij Jongeren. Master thesis, Psychology.
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Abstract
Background: The use of antidepressants has increased the last years, also among young people. Antidepressants have been shown effective for treating depression and have been approved by the US Food and Drug Administration (FDA). Previous research has shown that there has been publication bias in research on antidepressants for adults. For example, Serious Adverse Events (SAE’s) are not always accurately reported. However, not much is known about this for young people. This study investigates whether there is bias in studies into the safety of antidepressants, fluoxetine and escitalopram, for the treatment of depression in young people. Methods and Findings: This is investigated by comparing SAE data in FDA-reviews with the SAE data in the published articles. We have two FDA-reviews, one on fluoxetine and one on escitalopram. In total, these reviews contain nine trials. For five of the nine trials, the SAE data in the FDA-reviews is completely missing, incomplete or pooled. In addition, in two of the nine journal articles SAE data is completely missing. Besides that, suicide-related events in the journal articles are often not considered to be SAE. Conclusions: Current research shows that there not particularly bias in research into the safety of antidepressants for the treatment of depression in young people. There is more talk of incomplete reporting of the SAE data, especially in FDA-reviews. In many FDA-reviews, SAE’s are not reported at all or the data is incomplete or pooled. In contrast, SAE’s are reported in the majority of journal articles, but suicide-related events are often not reported as SAE in journal articles.
| Item Type: | Thesis (Master) |
|---|---|
| Supervisor name: | Roest, A.M. |
| Degree programme: | Psychology |
| Differentiation route: | Ontwikkelingspsychologie (O) [Master Psychology] |
| Date Deposited: | 01 Sep 2022 12:30 |
| Last Modified: | 01 Sep 2022 12:30 |
| URI: | http://gmwpublic.studenttheses.ub.rug.nl/id/eprint/1413 |
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