Esketamine on Postpartum Depression in Cesarean Section Women (EKET)

Effect of Prophylactic Esketamine on Postpartum Depression in Cesarean Section: A Multicenter, Prospective, Randomized, Controlled Study

This study was to explore the preventive effect of esketamine on postpartum depression in cesarean section, and to evaluate the safety of the drug

Study Overview

• Status: Recruiting
• Conditions: Postpartum Depression; Esketamine
• Intervention / Treatment: Drug: Normal saline; Drug: Esketamine

Detailed Description

Studies have shown that esketamine can treat clinical refractory depression, the drug takes effect quickly, can quickly eliminate the patient's suicide intention, low-dose maintenance treatment is conducive to the stability of the patient's condition, and less adverse reactions, is the current hot spot of antidepressant drug research. Esketamine has been approved by FDA for the treatment of refractory and suicidal depression, but can it effectively prevent and treat postpartum depression? It is not clear. Based on this, this study aims to explore the preventive effect of prophylactic administration of esketamine on postpartum depression in cesarean section, and evaluate the safety of the drug.

• Study Type: Interventional
• Enrollment (Estimated): 1248
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Feng Gao, Dr.; Phone Number: 86-27-83663173; Email: fgao@tjh.tjmu.edu.cn
• Study Contact Backup: Name: aijun xu, Dr.; Phone Number: 86-27-83663173; Email: ajxu@tjh.tjmu.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Recruiting
      • Tongji Hospital
      • Contact: Feng Gao, Dr.; Phone Number: 27-83663173; Email: fgao@tjh.tjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Elective cesarean section;
• 18-40 years;
• Primipara;
• Singleton pregnancy;
• Sign informed consent.

Exclusion Criteria:

• ASA grade III and above;
• Intracranial hypertension;
• Hypertension;
• Severe heart disease;
• Hyperthyroidism patients without treatment or insufficient treatment;
• Liver and kidney dysfunction;
• Preeclampsia or eclampsia;
• Mental disorder, mental retardation;
• Drug abuse and alcoholism;
• Contraindication of intraspinal anesthesia;
• The preoperative EPDS score ≥10;
• Participated in other clinical studies.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: N group; 15 minutes after umbilical cord amputation, the patient was intravenously injected with 10 ml normal saline	Drug: Normal saline; 10 ml normal saline; Other Names: Ns group
Experimental: Es group; 15 minutes after umbilical cord amputation, the patient was intravenously injected with 0.25mg/kg esketamine, PCIA regimen: sufentanil 100 μ g, esketamine 80 mg, diluted to 100 ml with 0.9% normal saline, set analgesia pump background infusion dose 2 ml/h, single bolus dose 2 ml, locking time 8 minutes.	Drug: Esketamine; After delivery, the parturient was given a loading dose of esketamine, and then a small dose of esketamine was added into PCIA analgesia pump; Other Names: Es group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh Postnatal Depression Scale(EPDS） scores	EPDS score is 0-30，and ≥ 10 to indicate depression	up to 90 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Scale/Score (VAS) score	VAS score is 0-100，and ≥ 30 to indicate the pain needs treatment	1 Day before operation
total number of PCA compressions	the total number of PCA compressions which the patients pressed	up to 24 hours after operation
total volume of PCA	the total volume of PCA drugs which the patients needed in 24h after sugery	up to 24 hours after operation

Collaborators and Investigators

• Sponsor: Ailin Luo
• Collaborators: The First Affiliated Hospital of Anhui Medical University; The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; The First Affiliated Hospital of University of South China; Central South University; Guangdong Women and Children Hospital; Maternal and Child Health Hospital of Hubei Province; Shandong Jining No.1 People's Hospital; First Affiliated Hospital of Guangxi Medical University; Third Affiliated Hospital of Zhengzhou University; Dalian Municipal Central Hospital
• Investigators: Principal Investigator: Ailin luo, Dr., Department of Anesthesiology of Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 25, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: July 2, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Depression, Postpartum; Psychotropic Drugs; Antidepressive Agents; Esketamine
• Other Study ID Numbers: EKET

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No