S-ketamine
DrugS-ketamine (0.2 mg/kg in 20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.
Other names: S-ketamine hydrochloride
NCT Number: NCT03927378
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.
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Notify Me18 year and older
Female
Interventional
Not applicable
Beijing Tiantan Hospital, Beijing, Beijing Municipality, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
S-ketamine (0.2 mg/kg in 20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.
Other names: S-ketamine hydrochloride
Placebo (20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.
Other names: Normal saline
Time frame: 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.
Time frame: At 7 days after childbirth.
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 42 days after childbirth.
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.
Maternal depression severity will be assessed with the Hamilton Depression Scale-17
Time frame: At 1, 7, and 42 days after childbirth.
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.
The mode of baby feeding include breast feeding, mixed feeding, or formula feeding.
Time frame: Up to 30 days after giving birth.
Length of hospital stay after giving birth.
Time frame: Up to 42 days after giving birth.
Maternal complications are defined as those that are harmful to maternal health and require medical intervention.
Time frame: Up to 42 days after birth.
Neonatal diseases are defined as those that require medical intervention.
Peking University First Hospital
Other
Effects of Low-dose S-Ketamine on Incidence of Postpartum Depression in Parturients With Prenatal Depression: A Randomized, Double-blind, Placebo-controlled Trial
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