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Completed

NCT Number: NCT04860661

Esketamine on Postpartum Depression in Cesarean Section Women

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

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Key information

Conditions

Esketamine Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Postpartum Depression Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tongji Hospital

Wuhan, Hubei, 430000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • American Society of Anesthesiologists (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.

Treatment and study plan

Esketamine

Drug

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

normal saline

Drug

10 ml normal saline

Other names: Ns group

Primary outcomes

  1. Edinburgh Postnatal Depression Scale(EPDS） scores

    Time frame: up to 90 days after surgery

    EPDS score is 0-30，and ≥ 10 to indicate depression

Secondary outcomes

  1. Numeric Rating Scale (NRS) score

    Time frame: 1 Day before operation

    NRS score is 0-10，and ≥ 4 to indicate the pain needs treatment

  2. total number of patient-controlled analgesia (PCA) compressions

    Time frame: up to 24 hours after operation

    the total number of PCA compressions which the patients pressed

  3. total volume of PCA

    Time frame: up to 24 hours after operation

    the total volume of PCA drugs which the patients needed in 24h after surgery

Sponsors and collaborators

Lead sponsor

Ailin Luo

Other

Collaborators

  • Jingmen No.1 People's Hospital
  • Maternal and Child Health Hospital of Hubei Province

Registry information

Official study title

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

Acronym: EKET

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Apr 27, 2021
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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