Low-dose S-ketamine in Women With Prenatal Depression

April 1, 2023 updated by: Dong-Xin Wang, Peking University First Hospital

Effects of Low-dose S-ketamine on the Incidence of Postpartum Depression in Women With Prenatal Depression: a Randomized, Double-blind, Placebo-controlled Trial

Prenatal depression is an important risk factor of postpartum depression. Low-dose ketamine has been used for depression treatment. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusion after childbirth may reduce the incidence of postpartum depression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Studies have shown that prenatal depression symptoms are important predictors of postpartum depression. Screening of pregnant women's mental condition before giving birth, early identification of pregnant women with symptoms of prenatal depression, and providing appropriate interventions may play an important role in reducing the incidence of postpartum depression. Ketamine is an NMDA-receptor antagonist. In recent years, many studies confirmed that ketamine has a significant antidepressant effect. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. In clinical application, s-ketamine has stronger analgesic effect, better anesthetic effect and lower incidence of adverse psychological reactions. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusions after childbirth may reduce postpartum depression. Evidence is lacking in this regard.

Study Type

Interventional

Enrollment (Actual)

364

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Peking University First Hospital
      • Beijing, Beijing, China
        • Beijing Tiantan Hospital
      • Beijing, Beijing, China
        • Peking University International Hospital
    • Hunan
      • Changsha, Hunan, China
        • Hunan Provincial Maternal and Child Health Care Hospital
    • Jiangsu
      • Huaian, Jiangsu, China
        • Huaian Maternal and Child Health Care Hospital
      • Nanjing, Jiangsu, China
        • Nanjing Maternal and Child Health Care Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Women's Hospital School of Medicine Zhejiang University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Maternal age ≥18 years;
  2. Prenatal Edinburgh postnatal depression scale score ≥10 points.

Exclusion Criteria:

  1. A clear history of mental illness (depression, schizophrenia, etc.) or communication difficulties;
  2. Severe pregnancy complications, such as severe preeclampsia, placental implantation, HELLP (syndrome hemolytic anemia, elevated liver function and low platelet count) syndrom, placenta previa, and placental abruption;
  3. American Society of Anesthesiologists classification ≥III;
  4. Presence of contraindications to ketamine/s-ketamine use, such as refractory hypertension, severe cardiovascular disease (New York Heart Association classification ≥III), and hyperthyroidism.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: S-katamine group
For women in this group, study drug (s-ketamine 0.2 mg/kg in 20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. Women will be monitored for 60 minutes and then sent back to the ward.
Drug: S-ketamine
For women in this group, active drug (s-ketamine 0.2 mg/kg in 20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. They will be monitored for 60 minutes and then sent back to the ward.
Other Names:
  • S-ketamine hydrochloride
Placebo Comparator: Placebo group
For women in this group, study drug (20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. Women will be monitored for 60 minutes and then sent back to the ward.
Drug: Placebo
For women in this group, placebo (20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. They will be monitored for 60 minutes and then sent back to the ward.
Other Names:
  • Normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of depression at 42 days postpartum.
Time Frame: At 42 days after childbirth.
Depression at 42 days postpartum will be diagnosed by psychiatrists according to the Mini-International Neuropsychiatric Interview (MINI)-6.0.
At 42 days after childbirth.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal depression score at 7 days postpartum.
Time Frame: At 7 days after childbirth.
Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a telephone interview.
At 7 days after childbirth.
Maternal depression score at 42 days postpartum.
Time Frame: At 42 days after childbirth.
Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a face-to-face interview or an online video interview.
At 42 days after childbirth.
Maternal depression severity at 42 days postpartum.
Time Frame: At 42 days after childbirth.
Maternal depression severity will be assessed with the Hamilton Depression Scale-17 (HAMD; score range 0-52, with higher score indicating more severe depression). The assessment will be conducted by a face-to-face interview or an online video interview.
At 42 days after childbirth.
Intensity of pain at 1, 7, and 42 days postpartum.
Time Frame: At 1, 7, and 42 days after childbirth.
Intensity of pain will be assessed with the numeric rating scale (a 11-point scale where 0=no pain and 10=the worst pain).
At 1, 7, and 42 days after childbirth.
Maternal breast feeding at 1, 7, and 42 days postpartum.
Time Frame: At 1, 7, and 42 days after childbirth.
The mode of baby feeding include breast feeding, mixed feeding, or formula feeding.
At 1, 7, and 42 days after childbirth.
Length of hospital stay after giving birth.
Time Frame: Up to 30 days after giving birth.
Length of hospital stay after giving birth.
Up to 30 days after giving birth.
Incidence of maternal complications within 42 days postpartum.
Time Frame: Up to 42 days after giving birth.
Maternal complications are defined as those that are harmful to maternal health and require medical intervention.
Up to 42 days after giving birth.
Incidence of neonatal diseases within 42 days.
Time Frame: Up to 42 days after birth.
Neonatal diseases are defined as those that require medical intervention.
Up to 42 days after birth.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

Peking University International Hospital
Women's Hospital School Of Medicine Zhejiang University
Hunan Provincial Maternal and Child Health Care Hospital
Women's Hospital of Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2020

Primary Completion (Actual)

August 3, 2022

Study Completion (Actual)

August 3, 2022

Study Registration Dates

First Submitted

June 1, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (Actual)

June 4, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

April 1, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019[336]

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will be available by contacting Dr. Dong-Xin Wang (wangdongxin@hotmail.com) after the trial is completed.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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