An interventional study of S-ketamine and Placebo in Prenatal Depression, Ketamine and Postpartum Depression, sponsored by Peking University First Hospital. Completed at 7 sites in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-04.
Sponsored by Peking University First Hospital · Not applicable, Interventional, and Prevention
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.
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.
528 studies on the registry are indexed under Depression, Postpartum; 124 are open to participants now.
This study's enrollment of 364 is above the median of 105 across 425 interventional studies indexed under Depression, Postpartum.
Browse Depression, Postpartum studies →Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
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Exclusion Criteria:
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.
Drug: S-ketamine
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.
Drug: Placebo
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.
Also known as: S-ketamine hydrochloride
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.
Also known as: Normal saline
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.
Time frame: At 42 days after childbirth.
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.
Time frame: At 7 days after childbirth.
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.
Time frame: At 42 days after childbirth.
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.
Time frame: At 42 days after childbirth.
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).
Time frame: At 1, 7, and 42 days after childbirth.
Maternal breast feeding at 1, 7, and 42 days postpartum.
The mode of baby feeding include breast feeding, mixed feeding, or formula feeding.
Time frame: At 1, 7, and 42 days after childbirth.
Length of hospital stay after giving birth.
Length of hospital stay after giving birth.
Time frame: Up to 30 days 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.
Time frame: Up to 42 days after giving birth.
Incidence of neonatal diseases within 42 days.
Neonatal diseases are defined as those that require medical intervention.
Time frame: Up to 42 days after birth.
Plan to share: No — IPD will be available by contacting Dr. Dong-Xin Wang (wangdongxin@hotmail.com) after the trial is completed.
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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Peking University First Hospital