Esketamine on Postpartum Depression in Cesarean Section Women

Postpartum Depression Clinical Trial

— EKET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04860661
• Other study ID #: EKET
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Tongji Hospital
• Contact: Feng Gao, Dr.
• Phone: 86-27-83663173
• Email: fgao[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1248
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Esketamine
• Postpartum Depression

Intervention

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
• Normal saline
10 ml normal saline

Locations

Country	Name	City	State
China	Tongji Hospital	Wuhan	Hubei

Sponsors (11)

Lead Sponsor

Collaborator

Ailin Luo

Central South University, Dalian Municipal Central Hospital, First Affiliated Hospital of Guangxi Medical University, Guangdong Women and Children Hospital, Maternal and Child Health Hospital of Hubei Province, Shandong Jining No.1 People's Hospital, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, The First Affiliated Hospital of Anhui Medical University, The First Affiliated Hospital of University of South China, Third Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Edinburgh Postnatal Depression Scale(EPDS) scores	EPDS score is 0-30,and = 10 to indicate depression	up to 90 days after surgery
Secondary	Visual Analogue Scale/Score (VAS) score	VAS score is 0-100,and = 30 to indicate the pain needs treatment	1 Day before operation
Secondary	total number of PCA compressions	the total number of PCA compressions which the patients pressed	up to 24 hours after operation
Secondary	total volume of PCA	the total volume of PCA drugs which the patients needed in 24h after sugery	up to 24 hours after operation