Back to resultsLow-dose S-Ketamine and Postpartum Depression in Parturients With Prenatal Depression
Primary Purpose
Prenatal Depression, Ketamine, Postpartum Depression
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
S-ketamine
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Prenatal Depression focused on measuring Prenatal Depression, S-Ketamine, Postpartum Depression
Eligibility Criteria
Inclusion Criteria:
- Parturients with age ≥18 years;
- Presence of prenatal depression (EPDS score ≥10);
- Provide written informed consents.
Exclusion Criteria:
- History of psychiatric disease (schizophrenia) or communication barriers that prevent normal communication before childbirth;
- Severe complications during pregnancy (such as severe preeclampsia, placenta accreta, or HELLP [Hemolysis, Elevated Liver enzymes and Low Platelets] syndrome);
- ASA physical status classification ≥III;
- Presence of contraindications to ketamine, including refractory hypertension, severe cardiovascular disease (heart function classification ≥III), or hyperthyroidism;
- Refuse to participate.
Sites / Locations
- Peking University First Hospital
- Beijing Tiantan Hospital
- Peking University International Hospital
- Hunan Provincial Maternal and Child Health Care Hospital
- Huaian Maternal and Child Health Care Hospital
- Nanjing Maternal and Child Health Care Hospital
- Women's Hospital School Of Medicine Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
S-katamine group
Placebo group
Arm Description
For women in this group, study drug (s-ketamine 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. Women will be monitored for 60 minutes and then sent back to the ward.
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. Women will be monitored for 60 minutes and then sent back to the ward.
Outcomes
Primary Outcome Measures
The incidence of depression at 42 days after childbirth.
PDepression at 42 days postpartum will be diagnosed by psychiatrists according to the Mini-International Neuropsychiatric Interview (MINI)-6.0.
Secondary Outcome Measures
Maternal depression score at 7 days postpartum.
Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a telephone interview.
Maternal depression score at 42 days postpartum.
Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a face-to-face interview or an online video interview.
Maternal depression severity at 42 days postpartum.
Maternal depression severity will be assessed with the Hamilton Depression Scale-17
Intensity of pain at 1, 7, and 42 days postpartum.
Intensity of pain will be assessed with the numeric rating scale (a 11-point scale where 0=no pain and 10=the worst pain).
Maternal breast feeding at 1, 7, and 42 days postpartum.
The mode of baby feeding include breast feeding, mixed feeding, or formula feeding.
Length of hospital stay after giving birth.
Length of hospital stay after giving birth.
Incidence of maternal complications within 42 days postpartum.
Maternal complications are defined as those that are harmful to maternal health and require medical intervention.
Incidence of neonatal diseases within 42 days.
Neonatal diseases are defined as those that require medical intervention.
Full Information
NCT ID
NCT03927378
First Posted
April 23, 2019
Last Updated
April 1, 2023
Sponsor
Peking University First Hospital
Collaborators
Peking University International Hospital, Hunan Provincial Maternal and Child Health Care Hospital, Women's Hospital of Nanjing Medical University, Women's Hospital School Of Medicine Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT03927378
Brief Title
Low-dose S-Ketamine and Postpartum Depression in Parturients With Prenatal Depression
Official Title
Effects of Low-dose S-Ketamine on Incidence of Postpartum Depression in Parturients With Prenatal Depression: A Randomized, Double-blind, Placebo-controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 19, 2020 (Actual)
Primary Completion Date
August 3, 2022 (Actual)
Study Completion Date
August 3, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University First Hospital
Collaborators
Peking University International Hospital, Hunan Provincial Maternal and Child Health Care Hospital, Women's Hospital of Nanjing Medical University, Women's Hospital School Of Medicine Zhejiang University
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
Prenatal depression is an important risk factor of postpartum depression. Low-dose ketamine has been used for depression treatment. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusion after childbirth may reduce the incidence of postpartum depression.
Detailed Description
Studies have shown that prenatal depression symptoms are important predictors of postpartum depression. Screening of pregnant women's mental condition before giving birth, early identification of pregnant women with symptoms of prenatal depression, and providing appropriate interventions may play an important role in reducing the incidence of postpartum depression. Ketamine is an NMDA-receptor antagonist. In recent years, many studies confirmed that ketamine has a significant antidepressant effect. As a stereoisomer of ketamine, s-ketamine has similar effects to ketamine in anti-depression. In clinical application, s-ketamine has stronger analgesic effect, better anesthetic effect and lower incidence of adverse psychological reactions. We speculate that, for pregnant women with prenatal depression, low-dose s-ketamine infusions after childbirth may reduce postpartum depression. Evidence is lacking in this regard.
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, S-Ketamine, Postpartum Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
364 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S-katamine group
Arm Type
Experimental
Arm Description
For women in this group, study drug (s-ketamine 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. Women will be monitored for 60 minutes and then sent back to the ward.
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. Women will be monitored for 60 minutes and then sent back to the ward.
Intervention Type
Drug
Intervention Name(s)
S-ketamine
Other Intervention Name(s)
S-ketamine hydrochloride
Intervention Description
S-ketamine (0.2 mg/kg in 20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal saline
Intervention Description
Placebo (20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.
Primary Outcome Measure Information:
Title
The incidence of depression at 42 days after childbirth.
Description
PDepression at 42 days postpartum will be diagnosed by psychiatrists according to the Mini-International Neuropsychiatric Interview (MINI)-6.0.
Time Frame
At 42 days after childbirth.
Secondary Outcome Measure Information:
Title
Maternal depression score at 7 days postpartum.
Description
Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a telephone interview.
Time Frame
At 7 days after childbirth.
Title
Maternal depression score at 42 days postpartum.
Description
Maternal depression will be assessed with the Edinburgh Postnatal Depression Scale (EPDS; score range 0-30, with higher score indicating more severe depression). The assessment will be conducted by a face-to-face interview or an online video interview.
Time Frame
At 42 days after childbirth.
Title
Maternal depression severity at 42 days postpartum.
Description
Maternal depression severity will be assessed with the Hamilton Depression Scale-17
Time Frame
At 42 days after childbirth.
Title
Intensity of pain at 1, 7, and 42 days postpartum.
Description
Intensity of pain will be assessed with the numeric rating scale (a 11-point scale where 0=no pain and 10=the worst pain).
Time Frame
At 1, 7, and 42 days after childbirth.
Title
Maternal breast feeding at 1, 7, and 42 days postpartum.
Description
The mode of baby feeding include breast feeding, mixed feeding, or formula feeding.
Time Frame
At 1, 7, and 42 days after childbirth.
Title
Length of hospital stay after giving birth.
Description
Length of hospital stay after giving birth.
Time Frame
Up to 30 days after giving birth.
Title
Incidence of maternal complications within 42 days postpartum.
Description
Maternal complications are defined as those that are harmful to maternal health and require medical intervention.
Time Frame
Up to 42 days after giving birth.
Title
Incidence of neonatal diseases within 42 days.
Description
Neonatal diseases are defined as those that require medical intervention.
Time Frame
Up to 42 days after birth.
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parturients with age ≥18 years;
Presence of prenatal depression (EPDS score ≥10);
Exclusion Criteria:
A clear history of mental illness (depression, schizophrenia, etc.) or communication difficulties;
Severe pregnancy complications, such as severe preeclampsia, placental implantation, HELLP (syndrome hemolytic anemia, elevated liver function and low platelet count) syndrom, placenta previa, and placental abruption;
American Society of Anesthesiologists classification ≥III;
Presence of contraindications to ketamine/s-ketamine use, such as refractory hypertension, severe cardiovascular disease (New York Heart Association classification ≥III), and 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
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing Tiantan Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Peking University International Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Hunan Provincial Maternal and Child Health Care Hospital
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Huaian Maternal and Child Health Care Hospital
City
Huaian
State/Province
Jiangsu
Country
China
Facility Name
Nanjing Maternal and Child Health Care Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Women's Hospital School Of Medicine Zhejiang University
City
Hanzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Low-dose S-Ketamine and Postpartum Depression in Parturients With Prenatal Depression
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