アブストラクト | INTRODUCTION: Replicated evidence indicates that ketamine and esketamine reduce measures of suicidality in persons with treatment-resistant depression (TRD). It remains uncertain whether individuals experience worsening of preexisting suicidality with either agent. RESEARCH DESIGN AND METHODS: The Food and Drug Administration Adverse Event Reporting System (FAERS) database was searched from 1970 and 2019 to 30 September 2023 for reports of suicidal ideation, depression suicidal, suicidal behavior, suicidal attempt, and completed suicide in association with ketamine and esketamine exposure, respectively. We present reporting odds ratios (ROR) significance was determined when the lower limit of the 95% confidence interval (CI) exceeded 1.0. Lithium was used as the control agent. RESULTS: Observed a higher ROR for suicidal ideation (ROR 7.58, 95% CI 6.34-9.07) and depression suicidal (ROR 14.19, 95% CI 1.80-112.07) with esketamine. Significantly lower RORs were observed for suicide attempt with ketamine (ROR 0.15, 95% CI 0.11-0.21) and esketamine (ROR 0.57, 95% CI 0.48-0.67). CONCLUSIONS: Mixed RORs across aspects of suicidality were observed with ketamine and esketamine. Limitations of the FAERS database prevent any determination of causal effects new onset suicidality to either agent. The lower RORs for suicide attempt with ketamine and esketamine is noted but cannot be interpreted as a direct therapeutic effect. |
ジャーナル名 | Expert opinion on drug safety |
投稿日 | 2024/6/17 |
投稿者 | McIntyre, Roger S; Mansur, Rodrigo B; Rosenblat, Joshua D; Teopiz, Kayla M; Kwan, Angela T H |
組織名 | Department of Psychiatry, University of Toronto, Toronto, ON, Canada.;Department of Pharmacology and Toxicology, University of Toronto, Toronto, ON,;Canada.;Brain and Cognition Discovery Foundation, Toronto, ON, Canada.;Mood Disorders Psychopharmacology Unit, University Health Network, Toronto, ON,;Faculty of Medicine, University of Ottawa, Ottawa, ON, Canada. |
Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/38884147/ |