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

Primary Purpose

Prenatal Depression, Ketamine, Postpartum Depression

Status
Active
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Esketamine
Placebo
Sponsored by
Peking University First Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prenatal Depression focused on measuring Prenatal Depression, Esketamine, Postpartum Depression, Long-Term Prognosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Hunan Provincial Maternal and Child Health Care Hospital
  • Women's Hospital of Nanjing Medical University
  • Women's Hospital, Zhejiang University School of Medicine
  • Peking University First Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Esketamine group

placebo group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Incidence maternal depression at 2 years postpartum
Incidence of depression in women at 2 years postpartum. Diagnosis was made according to M.I.N.I. 6.0.

Secondary Outcome Measures

PHQ-9 scores and incidence of moderate-severe depression in women at 2 years postpartum.
PHQ-9 score and moderate-severe depression (PHQ-9 score ≥10) in women at 2 years postpartum.
Incidence of chronic pain in women at 2 years postpartum
Incidence of chronic pain in women at 2 years postpartum
Incidence of developmental delay in offspring at 2 years of age
Incidence of developmental delay in offspring at 2 years of age measured by the Ages & Stages Questionnaires 3rd edition (ASQ-3) in Chinese

Full Information

First Posted
January 16, 2023
Last Updated
January 24, 2023
Sponsor
Peking University First Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05698394
Brief Title
Effect of Low-dose Esketamine on Maternal Depression at 2 Years After Childbirth
Official Title
Effect of Intravenous Low-dose Esketamine on Maternal Depression at 2 Years After Childbirth in Women With Prenatal Depression: 2-year Follow-up of a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 19, 2020 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Postpartum depression refers to the depression after childbirth. It is a common mental disorder after childbirth. In recent years, it has attracted more and more public attention. Studies have reported an incidence of postpartum depression ranging from 10% to 29%. Our previous findings showed that the incidence of depression at 42 days postpartum was 24.3%. Postpartum depression has adverse effects on physical and mental health of women, but also may have adverse influences on offspring including nutrition health, and cognitive and behavioral development. The pathogenesis of postpartum depression is not completely clear, and may be related to many factors, such as hormone level changes after childbirth, psychosocial factors, and adverse obstetric factors. Plently of studies have shown that prenatal depression is an important risk factor for postpartum depression. One meta-analysis showed that the incidence of postnatal depression could be as high as 39% in people with prenatal depression. Therefore, it is possible to reduce the occurrence of postpartum depression by active intervention of prenatal depressed parturients. Ketamine, an NMDA-receptor antagonist, is a classic analgesic drug with advantages of light respiratory and circulatory inhibition and good analgesic effect. Recently, it has been found to have antidepressant effect and has been widely used in the field of psychiatry. Esketamine, a S-enantiomer of racemic ketamine, has similar antidepressant effects to equivalent doses of ketamine, with a lower incidence of adverse reactions. In 2019, esketamine was approved by the US FDA for the treatment of treatment-resistant depression. At present, the results of studies on the use of esketamine in the perioperative period for the prevention and treatment of postoperative or postpartum depression are mixed. 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 administration of low-dose esketamine on the incidence of postpartum depression in women with prenatal depression. The multicenter study included 364 women who were given a low dose of esketamine intravenously after delivery. Preliminary results show that it can reduce the incidence of postpartum depression at 42 days. Here we conduct a 2-year follow-up of the women enrolled in the underlying trial to figure out the occurrence of 2-year maternal depression, and to explore the effect of immediate intravenous infusion of low-dose esketamine on the incidence of chronic depression at 2 years postpartum.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prenatal Depression, Ketamine, Postpartum Depression
Keywords
Prenatal Depression, Esketamine, Postpartum Depression, Long-Term Prognosis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
364 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Esketamine group
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Esketamine
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
normal saline, 0.9% sodium chloride
Intervention Description
20 ml normal saline will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth.
Primary Outcome Measure Information:
Title
Incidence maternal depression at 2 years postpartum
Description
Incidence of depression in women at 2 years postpartum. Diagnosis was made according to M.I.N.I. 6.0.
Time Frame
At 2 years postpartum (24-30 months)
Secondary Outcome Measure Information:
Title
PHQ-9 scores and incidence of moderate-severe depression in women at 2 years postpartum.
Description
PHQ-9 score and moderate-severe depression (PHQ-9 score ≥10) in women at 2 years postpartum.
Time Frame
At 2 years postpartum (24-30 months)
Title
Incidence of chronic pain in women at 2 years postpartum
Description
Incidence of chronic pain in women at 2 years postpartum
Time Frame
At 2 years postpartum (24-30 months)
Title
Incidence of developmental delay in offspring at 2 years of age
Description
Incidence of developmental delay in offspring at 2 years of age measured by the Ages & Stages Questionnaires 3rd edition (ASQ-3) in Chinese
Time Frame
At 2 years postpartum (24-30 months)

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dong-Xin Wang, MD,PhD
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hunan Provincial Maternal and Child Health Care Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Women's Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Women's Hospital, Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Name
Peking University First Hospital
City
Beijing
ZIP/Postal Code
100034
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
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Effect of Low-dose Esketamine on Maternal Depression at 2 Years After Childbirth

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