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Intraoperative Esketamine and Postpartum Depression Among Women With Cesarean Delivery: A Randomized Clinical Trial.

Li Ren, Ting Zhang, Bingyu Zou, Xin Su, Yi Tao, Jie Yang, Feng Lv, Ping Li, Fangliang Peng, Gangming Wu

JAMA Network Open February 3, 2025 DOI: 10.1001/jamanetworkopen.2024.59331 (opens in new tab)

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Study at a glance

AI-extracted from the abstract
Characteristics Randomized clinical trial Peer reviewed
Sample size 308
Population Pregnant women admitted for cesarean delivery at a single hospital in Chongqing, China
Intervention Esketamine
Dose 0.25 mg/kg
Duration Single intraoperative infusion over 20 minutes, with follow-up at 6 weeks postpartum
Topics Depression Esketamine
Keywords Postpartum depression Esketamine therapy Cesarean section Maternal mental health Anesthesia
Citations 13
Key findings Intraoperative esketamine reduced the incidence of postpartum depression at six weeks postpartum compared with placebo (10.4% vs 19.5%).

Abstract

Esketamine has been found to reduce the incidence of postpartum depression (PPD) in randomized clinical trials. However, current evidence from randomized clinical trials does not reflect esketamine's efficacy in clinical settings. To assess the clinical efficacy of intraoperative esketamine administration for preventing PPD among women who underwent cesarean delivery. This randomized clinical trial was conducted at The First Affiliated Hospital of Chongqing Medical University in Chongqing, China, from March 2023 to February 2024. Pregnant patients admitted for cesarean delivery were included, while those with intellectual dysfunction or contraindications to esketamine were excluded. All participants were assigned randomly to either the esketamine group or control group in a 1:1 ratio. Data analysis was based on the intention-to-treat principle. Patients in the esketamine group received an infusion of 0.25 mg/kg esketamine in 20 mL of saline over 20 minutes, whereas patients in the control group received 20 mL saline over 20 minutes. The primary outcome was the incidence of PPD at 6 weeks post partum. PPD was assessed using the Edinburgh Postnatal Depression Scale. A total of 308 pregnant women were randomly assigned to 1 of 2 groups: esketamine (n = 154; mean [SD] patient age, 31.57 [4.26] years) and control (n = 154; mean [SD] patient age, 32.53 [7.74] years). Incidence of PPD was significantly lower in the esketamine group compared with the control group at 6 weeks post partum (10.4% [16] vs 19.5% [30]; relative risk, 0.53; 95% CI, 0.30-0.93; P = .02). This randomized clinical trial demonstrated esketamine's advantage in reducing the incidence of PPD at 6 weeks post partum in patients who underwent cesarean delivery. The efficacy and safety of esketamine in preventing PPD warrant further investigation in clinical practice. Chinese Clinical Trial Registry Identifier: ChiCTR2200065494.

Comparable studies

Other randomized controlled trials on esketamine for depression, most cited first.

Study Year Design Participants
Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study Adults with moderate to severe nonpsychotic depression and a history of nonresponse to... 2019 Phase 3, double-blind, active-controlled, multicenter randomized controlled trial n = 227
Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression Adults with treatment-resistant depression who achieved stable remission or stable... 2019 Phase 3, multicenter, double-blind, randomized withdrawal study n = 297
Efficacy and Safety of Intranasal Esketamine Adjunctive to Oral Antidepressant Therapy in Treatment-Resistant Depression Adults with DSM-IV-TR diagnosis of major depressive disorder and history of inadequate... 2017 Phase 2, double-blind, doubly randomized, delayed-start, placebo-controlled study n = 67
Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study Depressed patients at imminent risk for suicide 2018 Randomized controlled trial n = 68
Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1) Adults with moderate-to-severe depression and nonresponse to at least two... 2019 Randomized controlled trial n = 346

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