Clinical Trial

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

Active, Not Recruiting Phase 4
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Record status
This record was last updated December 5, 2024 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2023-01-24.
Trial Details
NCT Number NCT05698394
Lead Sponsor Peking University First Hospital
Conditions Prenatal Depression, Ketamine, Postpartum Depression
Enrollment 364 participants
Start Date 2023-09-09
Primary Completion 2025-10 (estimated)
Study Completion 2025-11 (estimated)
Updated on ClinicalTrials.gov 2024-12-05