Clinical Trials Network and Institute, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Clinical Trials Network and Institute, Department of Psychiatry, Massachusetts General Hospital and Harvard Medical School, Boston, MA.
Eur Neuropsychopharmacol. 2021 Aug;49:122-132. doi: 10.1016/j.euroneuro.2021.04.024. Epub 2021 Jun 3.
This study aimed to assess the effect of a single infusion of intravenous (IV) ketamine on suicidal ideation in patients with treatment-resistant depression (TRD). Patients with TRD were randomized in a double-blind fashion to a single infusion of IV ketamine or IV midazolam placebo. Suicidal ideation was measured using the Montgomery-Asberg Depression Rating Scale (MADRS) suicide item at 3, 5, 7, 14 and 30 days post infusion. Clinically significant suicidal ideation was defined as a MADRS suicide item score ≥2. Forty patients who received IV ketamine and 16 who received IV midazolam had suicide item scores of ≥2 at baseline (IV ketamine group mean 2.90±0.74; IV midazolam group 2.69±0.70). The mean suicide scores of these groups differed significantly from each other on day 30; the IV ketamine group had a lower mean score than controls (2.03±1.59 vs. 3.00±1.41, t-test p = 0.049; Hedges' g 0.71). Among patients with a suicide score of ≥2 at baseline and <2 at day 3, the two groups did not differ significantly on mean scores changes at days 3, 5, 7, 14 or 30. Recurrence of suicidal ideation was extensive in both treatment groups. A single infusion of IV ketamine may reduce suicidal ideation in TRD out to 30 days post infusion, but early anti-suicidal effects appear to diminish rapidly. This post-hoc analysis was not powered to compare different doses of ketamine. A single infusion of IV ketamine might have a role as an adjunct to standard treatments in patients with TRD and suicidal ideation. Trial registration: NCT01920555.
这项研究旨在评估单次静脉注射(IV)氯胺酮对治疗抵抗性抑郁症(TRD)患者自杀意念的影响。TRD 患者以双盲方式随机分为 IV 氯胺酮或 IV 咪达唑仑安慰剂单次输注组。自杀意念采用蒙哥马利-阿斯伯格抑郁评定量表(MADRS)自杀条目在输注后 3、5、7、14 和 30 天进行评估。有临床意义的自杀意念定义为 MADRS 自杀条目评分≥2。40 名接受 IV 氯胺酮和 16 名接受 IV 咪达唑仑治疗的患者在基线时自杀条目评分≥2(IV 氯胺酮组平均 2.90±0.74;IV 咪达唑仑组 2.69±0.70)。这两组在第 30 天的自杀评分差异有统计学意义;IV 氯胺酮组的平均评分低于对照组(2.03±1.59 vs. 3.00±1.41,t 检验 p=0.049;Hedges' g 0.71)。在基线自杀评分≥2 且第 3 天<2 的患者中,两组在第 3、5、7、14 和 30 天的平均评分变化上无显著差异。两组患者的自杀意念均有复发。TRD 患者单次 IV 氯胺酮输注可能在输注后 30 天内降低自杀意念,但早期抗自杀作用似乎迅速减弱。这项事后分析没有比较不同剂量氯胺酮的能力。在有自杀意念的 TRD 患者中,单次 IV 氯胺酮输注可能作为标准治疗的辅助手段。试验注册:NCT01920555。