Effect of Low-dose Esketamine on Maternal Depression at 2 Years After Childbirth

This double-blind, randomized controlled trial (n=364) aims to investigate the effect of low-dose intravenous esketamine on the incidence of maternal depression at 2 years postpartum in women with prenatal depression.

Postpartum depression, a common mental disorder, has adverse effects on both maternal and offspring health. Previous research suggests that prenatal depression is a significant risk factor for postpartum depression, with incidence rates reported between 10% to 29%.

The study builds upon a previous trial that showed a reduction in postpartum depression incidence at 42 days postpartum following immediate postpartum intravenous infusion of low-dose esketamine. However, the long-term effects beyond 42 days remain unclear. The trial involves 364 pregnant women who participated in the previous trial and agreed to a 2-year follow-up.

Participants will be randomly assigned to receive either esketamine or placebo intravenously after delivery. The primary outcome measure is the incidence of maternal depression at 2 years postpartum, diagnosed using the M.I.N.I. 6.0. Secondary outcome measures include PHQ-9 scores, incidence of moderate-severe depression, incidence of chronic pain, and developmental delay in offspring at 2 years of age.

The study follows a parallel assignment design, with quadruple masking. It is being conducted at Peking University First Hospital in China. The trial started on June 19, 2020, and is estimated to complete in November 2024.

Trial Details

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.

NCT Number NCT05698394

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