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Clinical Trials in China / NCT05698394
Active, not recruiting Phase 4

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

NCT05698394 · tracked via the Priya Life Science China tracker
Sponsor
Peking University First Hospital
Phase
Phase 4
Started
2023-09-09
Last updated
2024-12-05

Condition(s) studied

Prenatal DepressionKetaminePostpartum Depression

Investigational drug(s) / intervention(s)

EsketaminePlacebo

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

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

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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (4)

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

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05698394 on ClinicalTrials.gov ↗ ← All trials in China