Safety Profile and Suicidality Associated with Use of Esketamine in the Treatment of Major Depressive Disorder

• DOI: 10.20944/preprints202503.2364.v1
• Publication Date: 2025-04-01T01:29:14Z
• Authors: Ilaria Ammendolia; Carmen Mannucci; Emanuela Esposito; Gioacchino Calapai; Mariaconcetta Currò; Paola Midiri; Cristina Mondello; Luigi Cardia; Fabrizio Calapai

Background/ Objective: Major depressive disorder (MDD) is a common mental disorder, with significant part of patients developing treatment-resistant depression (TRD). Esketamine an antagonist the N-methyl-D-aspartate receptor indicated as nasal spray in combination other antidepressants for adults TRD. Signals suspected adverse reactions (SARs) to esketamine from EudraVigilance database European countries were analyzed more defined safety profile this drug real-world. Methods: SARs reported data system and disproportionality analysis indicating sui-cidality esketamine, comparison fluoxetine ven-lafaxine, was performed. Results: “Blood pressure increased” (15.4%) “Dissocia-tion” (15.0%), are frequently SARs. Sex distribution indicates prevalence women, except “Completed suicide”, signaled men, while (18-64 years) elders (65-85 ages largest number esketamine. Results show increase risk suicide when compared venlafaxine. Conclusions: Apart carefulness due known limitations pharmacovigilance research conducted by using datasystem spontaneous signals SARs, on points towards need greater attention following prescription depressed subjects. In regard, well regulatory agencies recommend, history suicide-related events or those exhibiting degree suicidal ideation prior begin treatment, should receive careful monitoring during treatment.