Szarmach Joanna, Cubała Wiesław Jerzy, Włodarczyk Adam, Gałuszko-Węgielnik Maria
Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Poland.
Neuropsychiatr Dis Treat. 2020 Oct 29;16:2539-2551. doi: 10.2147/NDT.S273287. eCollection 2020.
Ketamine exhibits antidepressant properties in treatment-resistant depression (TRD) with some concern over its cardiovascular safety and tolerability issues. This paper reports on the cardiovascular safety in short-term intravenous ketamine treatment in TRD inpatients with major depressive disorder (MDD) and bipolar disorder (BP).
The observational study population comprises 35 MDD and 14 BP subjects treated with intravenous ketamine.
Blood pressure (RR) and heart rate (HR) values returned to baseline within 1.5-hours post infusion with no sequelae for all study subjects. Six time points were analyzed for each infusion: 0', 15', 30', 45', 60' and 90' for RR and HR. After the infusion significant peaks in systolic (p = 0.004) and diastolic (p = 0.038) RR were seen. In concomitant medication with selective serotonin reuptake inhibitors (SSRIs), higher RR peaks (p = 0.020; p = 0.048) were seen as compared to other subjects. The decrease in HR was greater (p = 0.02) in the absence of concomitant medication with mood stabilizers as compared to subjects receiving mood stabilizing medication accompanied by the observation of a greater decrease in diastolic RR among those taking mood stabilizers (p = 0.009).
The study may be underpowered due to the small sample size. The observations apply to an inhomogeneous TRD population in a single-site, pilot study, with no blinding and are limited to the acute administration.
The study demonstrates good safety and tolerability profile of intravenous ketamine as add-on intervention to current psychotropic medication in TRD, regardless of the MDD or BP type of mood disorders. The abatement of elevated RR and BP scores was observed in time with no sequelae nor harm. Still, cardiovascular risks appear to be more pronounced in subjects with comorbid arterial hypertension and diabetes mellitus.
氯胺酮在难治性抑郁症(TRD)中具有抗抑郁特性,但人们对其心血管安全性和耐受性问题有所担忧。本文报告了重度抑郁症(MDD)和双相情感障碍(BP)的TRD住院患者短期静脉注射氯胺酮治疗中的心血管安全性。
观察性研究人群包括35名接受静脉注射氯胺酮治疗的MDD患者和14名BP患者。
所有研究对象在输注后1.5小时内血压(RR)和心率(HR)值恢复至基线水平,且无后遗症。每次输注分析六个时间点:RR和HR的0'、15'、30'、45'、60'和90'。输注后,收缩期RR(p = 0.004)和舒张期RR(p = 0.038)出现显著峰值。与其他受试者相比,在同时服用选择性5-羟色胺再摄取抑制剂(SSRI)时,RR峰值更高(p = 0.020;p = 0.048)。与接受心境稳定剂的受试者相比,未同时服用心境稳定剂时HR下降幅度更大(p = 0.02),同时观察到服用心境稳定剂者舒张期RR下降幅度更大(p = 0.009)。
由于样本量小,该研究可能效力不足。这些观察结果适用于单中心试点研究中异质性的TRD人群,未设盲法,且仅限于急性给药。
该研究表明,无论MDD或BP型心境障碍如何,静脉注射氯胺酮作为TRD中当前精神药物的附加干预措施,具有良好的安全性和耐受性。RR和BP升高分数及时减轻,无后遗症或危害。然而,合并动脉高血压和糖尿病的受试者心血管风险似乎更为明显。