关键词: FDA adverse event reporting system (FAERS) Suicide depression esketamine ketamine suicidality treatment resistant depression (TRD)

来  源:   DOI:10.1080/14740338.2024.2368827

Abstract:
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.
摘要:
重复的证据表明,氯胺酮和艾氯胺酮降低了难治性抑郁症(TRD)患者的自杀率。仍然不确定易感个体是否会经历与任何一种代理的先前存在的自杀倾向的恶化。
从1970年和2019年至2023年9月30日搜索了食品和药物管理局不良事件报告系统(FAERS)数据库中的自杀意念报告,抑郁症自杀,自杀行为,与氯胺酮和艾氯胺酮接触相关的自杀企图和完全自杀,分别。我们使用报告优势比(ROR)来呈现我们的数据,并且当95%置信区间(CI)的下限超过1.0时确定显著性。使用锂作为控制剂。
这里,我们观察到使用艾氯胺酮的自杀意念(ROR7.58,95%CI6.34-9.07)和抑郁症自杀(ROR14.19,95%CI1.80-112.07)的ROR较高.氯胺酮(ROR0.15,95%CI0.11-0.21)和艾氯胺酮(ROR0.57,95%CI0.48-0.67)的自杀未遂的ROR显着降低。
用氯胺酮和艾氯胺酮观察到在自杀性方面的混合ROR。FAERS数据库的局限性阻止了对将新发病的自杀性与任一代理联系起来的因果效应的任何确定。氯胺酮和艾氯胺酮自杀未遂的ROR较低,但不能,鉴于数据库的局限性,被解释为直接的治疗效果。
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