Department of Anaesthesiology, Peking University First Hospital, Beijing 100034, China
Department of Anaesthesiology, Peking University First Hospital, Beijing 100034, China.
BMJ. 2024 Apr 10;385:e078218. doi: 10.1136/bmj-2023-078218.
To determine whether a single low dose of esketamine administered after childbirth reduces postpartum depression in mothers with prenatal depression.
Randomised, double blind, placebo controlled trial with two parallel arms.
Five tertiary care hospitals in China, 19 June 2020 to 3 August 2022.
364 mothers aged ≥18 years who had at least mild prenatal depression as indicated by Edinburgh postnatal depression scale scores of ≥10 (range 0-30, with higher scores indicating worse depression) and who were admitted to hospital for delivery.
Participants were randomly assigned 1:1 to receive either 0.2 mg/kg esketamine or placebo infused intravenously over 40 minutes after childbirth once the umbilical cord had been clamped.
The primary outcome was prevalence of a major depressive episode at 42 days post partum, diagnosed using the mini-international neuropsychiatric interview. Secondary outcomes included the Edinburgh postnatal depression scale score at seven and 42 days post partum and the 17 item Hamilton depression rating scale score at 42 days post partum (range 0-52, with higher scores indicating worse depression). Adverse events were monitored until 24 hours after childbirth.
A total of 364 mothers (mean age 31.8 (standard deviation 4.1) years) were enrolled and randomised. At 42 days post partum, a major depressive episode was observed in 6.7% (12/180) of participants in the esketamine group compared with 25.4% (46/181) in the placebo group (relative risk 0.26, 95% confidence interval (CI) 0.14 to 0.48; P<0.001). Edinburgh postnatal depression scale scores were lower in the esketamine group at seven days (median difference -3, 95% CI -4 to -2; P<0.001) and 42 days (-3, -4 to -2; P<0.001). Hamilton depression rating scale scores at 42 days post partum were also lower in the esketamine group (-4, -6 to -3; P<0.001). The overall incidence of neuropsychiatric adverse events was higher in the esketamine group (45.1% (82/182) 22.0% (40/182); P<0.001); however, symptoms lasted less than a day and none required drug treatment.
For mothers with prenatal depression, a single low dose of esketamine after childbirth decreases major depressive episodes at 42 days post partum by about three quarters. Neuropsychiatric symptoms were more frequent but transient and did not require drug intervention.
ClinicalTrials.gov NCT04414943.
确定产后单次给予低剂量氯胺酮是否能降低产前抑郁母亲的产后抑郁症。
随机、双盲、安慰剂对照试验，设两个平行组。
中国五所三级保健医院，2020 年 6 月 19 日至 2022 年 8 月 3 日。
364 名年龄≥18 岁的母亲，产前抑郁程度至少为轻度，依据爱丁堡产后抑郁量表评分≥10（范围 0-30，得分越高表示抑郁越严重），并因分娩而住院。
参与者被随机分配 1:1 接受 0.2mg/kg 氯胺酮或安慰剂，在脐带夹闭后静脉输注 40 分钟。
主要结局为产后 42 天出现重度抑郁发作的患病率，采用迷你国际神经精神访谈进行诊断。次要结局包括产后 7 天和 42 天的爱丁堡产后抑郁量表评分，以及产后 42 天的 17 项汉密尔顿抑郁评定量表评分（范围 0-52，得分越高表示抑郁越严重）。不良事件监测至产后 24 小时。
共纳入 364 名（平均年龄 31.8（标准差 4.1）岁）母亲并进行随机分组。产后 42 天，氯胺酮组 12 名（12/180）参与者出现重度抑郁发作，安慰剂组 46 名（46/181）（相对风险 0.26，95%置信区间（CI）0.14 至 0.48；P<0.001）。氯胺酮组产后 7 天（中位数差值-3，95%CI -4 至 -2；P<0.001）和 42 天（-3，-4 至 -2；P<0.001）的爱丁堡产后抑郁量表评分较低。产后 42 天的汉密尔顿抑郁评定量表评分也较低（-4，-6 至 -3；P<0.001）。氯胺酮组总体神经精神不良事件发生率较高（45.1%（82/182）与 22.0%（40/182）；P<0.001）；然而，症状持续时间不到一天，且均无需药物治疗。
对于产前抑郁的母亲，产后单次给予低剂量氯胺酮可使产后 42 天重度抑郁发作减少约四分之三。神经精神症状更为频繁但短暂，且无需药物干预。
ClinicalTrials.gov NCT04414943。
