Low-dose S-Ketamine and Postpartum Depression in Parturients With Prenatal Depression
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03927378 |
Recruitment Status :
Recruiting
First Posted : April 25, 2019
Last Update Posted : April 20, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Perinatal Depression Ketamine Postpartum Depression | Drug: S-ketamine Drug: Placebo | Not Applicable |
Postpartum depression refers to maternal depression developed early after childbirth, with reported incidences varied from 10% to 20%. The development of postpartum depression produces harmful effects not only on mothers, but also on infants and young children. Prenatal depression or high depression score is an independent risk factor for the development of postpartum depression.
Ketamine is a commonly used general anesthetic. In addition, low-dose ketamine is recommended for antidepressant therapy. S-ketamine is more potent as an anaesthetic and might also have a better antidepressive effect. We hypothesize that low-dose s-ketamine has a therapeutic effect on parturients with prenatal depression. However, evidences in this aspect are insufficient. The purpose of this study is to investigate whether low-dose s-ketamine administered after childbirth can reduce the incidence of postpartum depression in parturients with prenatal depression.
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 364 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
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 |
Actual Study Start Date : | June 19, 2020 |
Estimated Primary Completion Date : | July 2022 |
Estimated Study Completion Date : | August 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: S-katamine group
Low-dose s-ketamine (0.2 mg/kg in 20 ml normal saline) is intravenously infused in 40 minutes after childbirth.
|
Drug: S-ketamine
S-ketamine (0.2 mg/kg in 20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.
Other Name: S-ketamine hydrochloride |
Placebo Comparator: Placebo group
Placebo (20 ml normal saline) is intravenously infused in 40 minutes after childbirth.
|
Drug: Placebo
Placebo (20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.
Other Name: Normal saline |
- The incidence of depression at 42 days after childbirth. [ Time Frame: At 42 days after childbirth. ]Postpartum depression at 42 days is diagnosed by using the Mini-International Neuropsychiatric Interview-Version 6.0 (MINI-V6.0) by a psychiatrist.
- The score of depression at 7 and 42 days after childbirth. [ Time Frame: At 7 and 42 days after childbirth. ]The score of depression at 7 and 42 days after childbirth is assessed by using the Edinburgh Postpartum Depression Scale (EPDS). This is a 10-item self-report questionnaire; each item is rated from 0 to 3 denoting the increasing severity of symptoms, resulting in a total score range from 0 to 30, with higher score indicating more severe depression.
- The score of pain at 1, 7 and 42 days after childbirth. [ Time Frame: At 1, 7 and 42 days after childbirth. ]The score of pain at 1, 7 and 42 days after childbirth is assessed by using a Numeric Rating Scale (an 11-point scale where 0 indicates no pain and 10 the worst pain).
- The proportion of neonates with breast-feeding. [ Time Frame: At 1, 7 and 42 days after childbirth. ]The proportion of neonates with breast-feeding.
- The incidence of postpartum complications within 42 days after childbirth. [ Time Frame: Up to 42 days after childbirth. ]The incidence of postpartum complications within 42 days after childbirth.
- The incidence of neonatal disease within 42 days after birth. [ Time Frame: Up to 42 days after childbirth. ]The incidence of neonatal disease within 42 days after birth.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03927378
Contact: Dong-Xin Wang, MD, PhD | 8610 83572784 | wangdongxin@hotmail.com | |
Contact: Yuan Zeng, MD | 8610 83572460 | yuan_zeng@sina.com |
China, Beijing | |
Peking University First Hospital | Recruiting |
Beijing, Beijing, China, 100034 | |
Contact: Dong-Xin Wang, MD, PhD 861083572784 wangdongxin@hotmail.com | |
Contact: Yuan Zeng, MD 861083572460 yuan_zeng@sina.com |
Principal Investigator: | Dong-Xin Wang, MD, PhD | Peking University First Hospital |
Responsible Party: | Dong-Xin Wang, Professor and Chairman, Department of Anesthesiology and Critical Care Medicine, Peking University First Hospital |
ClinicalTrials.gov Identifier: | NCT03927378 |
Other Study ID Numbers: |
2018[224] |
First Posted: | April 25, 2019 Key Record Dates |
Last Update Posted: | April 20, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Perinatal Depression S-Ketamine Postpartum Depression |
Depression, Postpartum Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders Puerperal Disorders Pregnancy Complications Ketamine Esketamine Analgesics Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antidepressive Agents Psychotropic Drugs |