Low-dose S-Ketamine and Postpartum Depression in Parturients With Prenatal Depression

Postpartum Depression Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03927378
• Other study ID #: 2018[224]
• Status: Completed
• Phase: N/A
• Start date: June 19, 2020
• Est. completion date: August 3, 2022

Study information

• Verified date: April 2023
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 364
• Est. completion date: August 3, 2022
• Est. primary completion date: August 3, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Parturients with age =18 years;

• Presence of prenatal depression (EPDS score =10);

Exclusion Criteria:

1. A clear history of mental illness (depression, schizophrenia, etc.) or communication difficulties;

2. 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;

3. American Society of Anesthesiologists classification =III;

4. Presence of contraindications to ketamine/s-ketamine use, such as refractory hypertension, severe cardiovascular disease (New York Heart Association classification =III), and hyperthyroidism.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Ketamine
• Postpartum Depression
• Prenatal Depression

Intervention

Drug:
• S-ketamine
S-ketamine (0.2 mg/kg in 20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.
• Placebo
Placebo (20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.

Locations

Country	Name	City	State
China	Beijing Tiantan Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University International Hospital	Beijing	Beijing
China	Hunan Provincial Maternal and Child Health Care Hospital	Changsha	Hunan
China	Women's Hospital School Of Medicine Zhejiang University	Hanzhou	Zhejiang
China	Huaian Maternal and Child Health Care Hospital	Huaian	Jiangsu
China	Nanjing Maternal and Child Health Care Hospital	Nanjing	Jiangsu

Sponsors (5)

Lead Sponsor	Collaborator
Peking University First Hospital	Hunan Provincial Maternal and Child Health Care Hospital, Peking University International Hospital, Women's Hospital of Nanjing Medical University, Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (31)

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* Note: There are 31 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At 42 days after childbirth.
Secondary	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.	At 7 days after childbirth.
Secondary	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.	At 42 days after childbirth.
Secondary	Maternal depression severity at 42 days postpartum.	Maternal depression severity will be assessed with the Hamilton Depression Scale-17	At 42 days after childbirth.
Secondary	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).	At 1, 7, and 42 days after childbirth.
Secondary	Maternal breast feeding at 1, 7, and 42 days postpartum.	The mode of baby feeding include breast feeding, mixed feeding, or formula feeding.	At 1, 7, and 42 days after childbirth.
Secondary	Length of hospital stay after giving birth.	Length of hospital stay after giving birth.	Up to 30 days after giving birth.
Secondary	Incidence of maternal complications within 42 days postpartum.	Maternal complications are defined as those that are harmful to maternal health and require medical intervention.	Up to 42 days after giving birth.
Secondary	Incidence of neonatal diseases within 42 days.	Neonatal diseases are defined as those that require medical intervention.	Up to 42 days after birth.