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NCT04414943 Clinical Trial

Low-dose S-ketamine in Women With Prenatal Depression

Postpartum Depression Clinical Trial

Official title:
Effects of Low-dose S-ketamine on the Incidence of Postpartum Depression in Women With Prenatal Depression: a Randomized, Double-blind, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04414943
Other study ID # 2019[336]
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

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Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• S-ketamine
For women in this group, active 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. They will be monitored for 60 minutes and then sent back to the ward.
• Placebo
For women in this group, placebo (20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. They will be monitored for 60 minutes and then sent back to the ward.

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 Hangzhou 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 (39)

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Outcome
Type Measure Description Time frame Safety issue
Primary The incidence of depression at 42 days postpartum. Depression 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 (HAMD; score range 0-52, 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 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.
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