Active, Not RecruitingPhase 4ketamine

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

Sponsored by Peking University First Hospital

NCT ID
NCT05698394
Target Enrollment
364 participants
Start Date
2023-09-09
Est. Completion
2025-11

About This Study

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.

Conditions Studied

Prenatal DepressionKetaminePostpartum Depression

Interventions

  • Esketamine
  • Placebo

Eligibility

Sex:FEMALE
Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility 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).

Study Locations (4)

Hunan Provincial Maternal and Child Health Care Hospital
Changsha, Hunan, China
Women's Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Women's Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Peking University First Hospital
Beijing, China

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source

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