Włodarczyk Adam, Cubała Wiesław J, Gałuszko-Węgielnik Maria, Szarmach Joanna
Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, Dębinki 7 St. Build. 25, Gdańsk, pomorskie 80-952, Poland.
Department of Psychiatry, Faculty of Medicine, Medical University of Gdańsk, Gdańsk, Pomorskie, Poland.
Ther Adv Psychopharmacol. 2021 May 19;11:20451253211011021. doi: 10.1177/20451253211011021. eCollection 2021.
There is evidence supporting the use of ketamine in treatment-resistant depression (TRD). However, there are some safety and tolerability concerns associated with ketamine. This study aimed to investigate ketamine's safety and tolerability to the central nervous system and to assess the relationship between dissociative symptomology and psychometric outcomes during and after intravenous ketamine treatment concurrent with treatment by varying psychotropic medications in treatment-refractory inpatients with major depressive disorder (MDD) and bipolar disorder (BP).
A total of 49 patients with MDD and BP were included in this study. The subjects were administered ketamine and were assessed for changes using an observational protocol.
No antidepressants were associated with psychomimetic symptomatology except for citalopram ( = 0.019). Patients treated with citalopram showed a higher intensity of psychomimetic symptomatology. The use of classic mood-stabilizers was significantly associated with an increase in psychomimetic symptomatology according to the Brief Psychiatric Rating Scale (BPRS; lamotrigine = 0.009, valproate = 0.048, lithium = 0.012). No sequelae were observed.
Despite the limitations that this study may be underpowered due to the small sample size, the sample consisted of a heterogeneous TRD population in a single site, and there no blinding of who underwent only acute ketamine administration, our observations indicate ketamine use requires close safety and tolerability monitoring with regards to psychomimetic and dissociative symptoms in TRD-BP and careful management for MDD patients. NCT04226963.
有证据支持氯胺酮用于治疗抵抗性抑郁症（TRD）。然而，氯胺酮存在一些安全性和耐受性问题。本研究旨在调查氯胺酮对中枢神经系统的安全性和耐受性，并评估在伴有难治性重度抑郁症（MDD）和双相情感障碍（BP）的住院患者中，静脉注射氯胺酮治疗期间及之后，解离症状与心理测量结果之间的关系，同时联合使用不同的精神药物进行治疗。
本研究共纳入49例MDD和BP患者。受试者接受氯胺酮治疗，并通过观察方案评估变化情况。
除西酞普兰外，没有抗抑郁药与拟精神病症状相关（P = 0.019）。接受西酞普兰治疗的患者拟精神病症状强度更高。根据简明精神病评定量表（BPRS），使用经典心境稳定剂与拟精神病症状增加显著相关（拉莫三嗪P = 0.009，丙戊酸盐P = 0.048，锂盐P = 0.012）。未观察到后遗症。
尽管本研究存在局限性，可能因样本量小而效能不足，样本由单一地点的异质性TRD人群组成，且未对仅接受急性氯胺酮给药的患者进行盲法处理，但我们的观察结果表明，在TRD-BP中使用氯胺酮时，需要密切监测拟精神病和解离症状的安全性和耐受性，并对MDD患者进行仔细管理。NCT04226963。
