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