CI

At a glance

ClinicalIndex Comparison Record
Phase 4Active· 364 enrolled
Drug / intervention
Esketamine +1 moredrug
Likely dose
Esketamine 0.2 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05698394
NCT05698394Phase 4Active

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

Peking University First Hospital·interventional·Posted Jan 26, 2023·Updated Dec 5, 2024

In Brief

A Phase 4 clinical trial evaluating Esketamine and Placebo for Prenatal Depression and 2 related conditions. Active but no longer recruiting, targeting 364 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesChina
Collaborators--

Timeline

Phase 4ActiveOverdue
2023202420252026
First PostedJan 26, 2023
Enrollment StartSep 9, 2023
Primary CompletionOct 1, 2025
Study CompletionNov 1, 2025
TodayJul 1, 2026
Enrollment to primary: 2.1 yearsPosted 3.4 years ago

Interventions

Esketaminedrug

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

Placebodrug

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