Active, not recruitingPhase 4

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

NCT05698394 · Peking University First Hospital

Closed to entry

Status

Not accepting participants

Phase 4

Phase

364

Target enrolment

Study sites

Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Incidence maternal depression at 3 years postpartum
Measured over At 3 years postpartum (33-41 months)

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years

Ages

FEMALE

Sex

Not accepted

Healthy volunteers

All 364 pregnant women who participated in the underling trial "Effect of low-dose esketamine on the incidence of postpartum depression in women with prenatal depression: a randomized, double-blind, placebo-controlled trial" NCT04414943）and agreed to accept this 2-year follow-up. The inclusion criteria of the underlying trial: * Maternal age ≥18 years; * Prenatal Edinburgh postnatal depression scale score ≥10 points. Exclusion Criteria of the previous study: * A clear history of mental illness (depression, schizophrenia, etc.) or communication disorders * Severe pregnancy complications (such as severe preeclampsia, placenta accreta, HELLP syndrome, placenta previa, placenta abruption) before surgery; * ASA grade ≥III; * The presence of contraindications to ketamine/esketamine use (e.g., stubborn, refractory hypertension, severe cardiovascular disease \[cardiac function grade ≥III\], hyperthyroidism).

Where

4 study sites

Facility	City	Region	Country
Hunan Provincial Maternal and Child Health Care Hospital	Changsha	Hunan	China
Women's Hospital of Nanjing Medical University	Nanjing	Jiangsu	China
Women's Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang	China
Peking University First Hospital	Beijing	—	China

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT05698394 on ClinicalTrials.gov →

Last updated in the registry 2024-12-05. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ketamine

Indication

All 7 trials from Peking University First Hospital →