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

NCT05698394 | Active Not Recruiting Phase 4

• 1 other identifier: 2022-562
• Study Type: interventional
• Target: 364
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Prenatal Depression; Ketamine; Postpartum Depression

Keywords

Prenatal Depression; Esketamine; Postpartum Depression; Long-Term Prognosis

Outcome Measures

Primary Outcomes (1)

• Incidence maternal depression at 3 years postpartum

  Incidence of depression in women at 3 years postpartum. Diagnosis was made according to M.I.N.I. 6.0.

  At 3 years postpartum (33-41 months)

Secondary Outcomes (3)

• PHQ-9 scores and incidence of moderate-severe depression in women at 3 years postpartum.

  At 3 years postpartum (33-41 months)

• Incidence of chronic pain in women at 3 years postpartum

  At 3 years postpartum (33-41 months)

• Incidence of developmental delay in offspring at 3 years of age

  At 3 years postpartum (33-41 months)

Study Arms (2)

Esketamine group

EXPERIMENTAL

For women in this group, study drug (esketamine 0.2 mg/kg in 20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth.

Drug: Esketamine

placebo group

PLACEBO COMPARATOR

For women in this group, study drug (20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth.

Drug: Placebo

Interventions

Esketamine DRUG

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

Esketamine group

Placebo DRUG

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

Also known as: normal saline, 0.9% sodium chloride

placebo group

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Maternal age ≥18 years;
• Prenatal Edinburgh postnatal depression scale score ≥10 points.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (4)

Hunan Provincial Maternal and Child Health Care Hospital

Changsha, Hunan, China

Location

Women's Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Women's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Peking University First Hospital

Beijing, 100034, China

Location

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MeSH Terms

Conditions

Depression, Postpartum

Interventions

Esketamine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Dong-Xin Wang, MD,PhD

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PHD, Professor and Chairman

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: January 26, 2023
• Study Start: September 9, 2023
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 5, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)