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Effect of Low-dose Esketamine on Maternal Depression at 3 Years After Childbirth

NCT05698394 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2024-12-05

No results posted yet for this study

Summary

Postpartum depression refers to the depression after childbirth, which is a common mental disorder in women. The pathogenesis of postpartum depression is not fully understood, and may be related to a variety of factors. Prenatal depression is an important risk factor for postpartum depression. Our recent multicenter randomized controlled trial, "Effect of Low-dose esketamine on the incidence of postpartum depression in women with prenatal depression", explored the effect of immediate postpartum intravenous infusion of low-dose esketamine on the incidence of postpartum depression in women with prenatal depression. The preliminary results showed that it reduced the incidence of postpartum depression at 42 days. Since there were no studies on the effect of intravenous esketamine infusion after delivery on long-term postpartum depression, this study is a long-term follow-up of the previous randomized trial. We aim to explore the effect of low-dose intravenous esketamine after delivery on the incidence of 2-year maternal depression after delivery in women with prenatal depressive symptoms.

Conditions

Interventions

DRUG

Esketamine

0.2 mg/kg S-ketamine in 20 ml normal saline will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth

DRUG

Placebo

20 ml normal saline will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth.

Sponsors & Collaborators

  • Peking University First Hospital

    lead OTHER

Principal Investigators

  • Dong-Xin Wang, MD,PhD · Peking University First Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-09
Primary Completion
2025-10-31
Completion
2025-11-30

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05698394 on ClinicalTrials.gov