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ACTIVE NOT RECRUITING
NCT05698394
PHASE4

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

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

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.

Official title: Effect of Intravenous Low-dose Esketamine on Maternal Depression at 3 Years After Childbirth in Women With Prenatal Depression: 3-year Follow-up of a Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

364

Start Date

2023-09-09

Completion Date

2025-11

Last Updated

2024-12-05

Healthy Volunteers

No

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.

Locations (4)

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