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

• Status: Active, not recruiting
• Trial end date: 2024-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking University First Hospital
• Treatments: Esketamine

Criteria

All 364 pregnant women who participated in the underling trial "Effect of low-dose esketamine on the incidence of postpartum depression in women with prenatal depression: a randomized, double-blind, placebo-controlled trial" NCT04414943）and agreed to accept this 2-year follow-up.

The inclusion criteria of the underlying trial:

• Maternal age ≥18 years;

• Prenatal Edinburgh postnatal depression scale score ≥10 points.

Exclusion Criteria of the previous study:

• A clear history of mental illness (depression, schizophrenia, etc.) or communication disorders

• Severe pregnancy complications (such as severe preeclampsia, placenta accreta, HELLP syndrome, placenta previa, placenta abruption) before surgery;

• ASA grade ≥III;

• The presence of contraindications to ketamine/esketamine use (e.g., stubborn, refractory hypertension, severe cardiovascular disease [cardiac function grade ≥III], hyperthyroidism).