The Reported Safety of Antidepressants for Youths with Generalized Anxiety Disorder and Obsessive-Compulsive Disorder

Rupert, Lotte (2023) The Reported Safety of Antidepressants for Youths with Generalized Anxiety Disorder and Obsessive-Compulsive Disorder. Master thesis, Psychology.

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Abstract

The safety of antidepressants can be overestimated in published literature compared to the reported safety of the FDA according to research. This paper investigated whether the reported safety of antidepressants used to treat children and adolescents with generalized anxiety disorder and obsessive-compulsive disorder showed discrepancies compared to the FDA approval packages. Outcome reporting bias was investigated concerning the reporting and description of serious adverse events (SAEs), related to suicide, suicide ideation and/ or self-harm. Four antidepressants were investigated, using FDA approval packages. The packages contained trials that were used to investigate efficacy and safety for market approval. These trials were matched to four articles, using a systematic search in PsycInfo and MEDLINE. Relevant safety data was extracted from the FDA packages and compared to the data available in the matched articles, to investigate outcome reporting bias and general discrepancies. There was no outcome reporting bias found in the four articles that were investigated. The data available from the articles were consistent with the data in the FDA packages. There was a publication bias concerning the extension period of the trial for fluvoxamine. The results are discussed in light of the black box warning of the FDA in 2004. The safety indication of the FDA based on the trials is also discussed. Further research can focus on investigating the reported safety of antidepressants for children and adolescents with major depressive disorder.

Item Type:	Thesis (Master)
Supervisor name:	Roest, A.M.
Degree programme:	Psychology
Differentiation route:	Ontwikkelingspsychologie (O) [Master Psychology]
Date Deposited:	24 Feb 2023 14:58
Last Modified:	24 Feb 2023 14:58
URI:	http://gmwpublic.studenttheses.ub.rug.nl/id/eprint/1740

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