EsketamineEKETNCT04860661
Esketamine on Postpartum Depression in Cesarean Section Women
A study testing Esketamine and Normal saline in people with Esketamine and Postpartum Depression, run by Ailin Luo at 1 site in China.
Trial summary
This study was to explore the preventive effect of esketamine on postpartum depression (PPD) in cesarean section, and to evaluate the safety of the drug Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Esketamine, Postpartum Depression
- What is being tested?
- Esketamine and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2021to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Elective cesarean section;
- 18-40 years;
- Primipara;
- Singleton pregnancy;
- Sign informed consent.
Who cannot join
- American Society of Anesthesiologists (ASA) grade III and above;
- Intracranial hypertension;
- Hypertension;
- Severe heart disease;
- Hyperthyroidism patients without treatment or insufficient treatment;
- Liver and kidney dysfunction;
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- Preeclampsia or eclampsia;
- Mental disorder, mental retardation;
- Drug abuse and alcoholism;
- Contraindication of intraspinal anesthesia;
- The preoperative EPDS score ≥10;
- Participated in other clinical studies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Prophylactic Esketamine on Postpartum Depression in Cesarean Section: A Multicenter, Prospective, Randomized, Controlled Study
This study was to explore the preventive effect of esketamine on postpartum depression (PPD) in cesarean section, and to evaluate the safety of the drug
Read the detailed description
Studies have shown that esketamine can treat clinical refractory depression, the drug takes effect quickly, can quickly eliminate the patient's suicide intention, low-dose maintenance treatment is conducive to the stability of the patient's condition, and less adverse reactions, is the current hot spot of antidepressant drug research. Esketamine has been approved by FDA for the treatment of refractory and suicidal depression, but can it effectively prevent and treat postpartum depression? It is not clear. Based on this, this study aims to explore the preventive effect of prophylactic administration of esketamine on postpartum depression in cesarean section, and evaluate the safety of the drug.
- Conditions
- Esketamine, Postpartum Depression
- Being tested
- Esketamine, Normal saline
- Medical subject headings
- Depression, Postpartum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EsketamineDrug
Also called Es group
After delivery, the parturient was given a loading dose of esketamine, and then a small dose of esketamine was added into PCIA analgesia pump
Normal salineDrug
Also called Ns group
10 ml normal saline
| Study group | Role | What they receive |
|---|---|---|
| N group | Placebo comparator | 15 minutes after umbilical cord amputation, the patient was intravenously injected with 10 ml normal saline Receives: Drug: Normal saline |
| Es group | Experimental | 15 minutes after umbilical cord amputation, the patient was intravenously injected with 0.25mg/kg esketamine, PCIA regimen: sufentanil 100 μ g, esketamine 80 mg, diluted to 100 ml with 0.9% normal saline, set analgesia pump background infusion dose 2 ml/h, single bolus dose 2 ml, locking time 8 minutes. Receives: Drug: Esketamine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Edinburgh Postnatal Depression Scale(EPDS） scores
EPDS score is 0-30，and ≥ 10 to indicate depression
Measured: up to 90 days after surgery
Secondary outcomes (3)
Numeric Rating Scale (NRS) score
NRS score is 0-10，and ≥ 4 to indicate the pain needs treatment
Measured: 1 Day before operation
total number of patient-controlled analgesia (PCA) compressions
the total number of PCA compressions which the patients pressed
Measured: up to 24 hours after operation
total volume of PCA
the total volume of PCA drugs which the patients needed in 24h after surgery
Measured: up to 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 May 2021
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EsketamineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The incidence of PPD: the EPDS scale was assessed by face-to-face or telephone interview of the Puerpera 7 d, 30 d, 60 d and 90 d after delivery. EPDS score ≥ 10 was defined as antenatal depression or postpartum emotional disorder.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 336 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ailin Luo
- Sponsor type
- University, hospital or other
- Collaborators
- Maternal and Child Health Hospital of Hubei Province, Jingmen No.1 People's Hospital
- Responsible party
- Sponsor-investigator, Ailin Luo, Tongji Hospital
- Investigators
- Ailin luo, Dr., Principal investigator, Department of Anesthesiology of Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04860661
- Sponsor's protocol ID
- EKET
- Acronym
- EKET
- Status last verified
- Aug 2024
- First submitted
- 20 Apr 2021
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chu T, Peng X, Wan K, Li M, Liu T, Shi X, Yao W, Li S, Zhou Z, Yang C, Xu H, Kong J, Wang C, Cheng J, Xu Z, Li D, Liu X, He J, Ye X, Luo A, Xu A, Gao F. Prophylactic esketamine to reduce postpartum depression in primiparae: A multicentre, double-blind, randomised clinical trial. Eur J Anaesthesiol. 2026 Jul 1;43(7):584-593. doi: 10.1097/EJA.0000000000002348. Epub 2026 Jan 28.
PubMed 41607308
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Prophylactic Esketamine on Postpartum Depression in Cesarean Section: A Multicenter, Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT04860661
- Acronym / sponsor ID
- EKET / EKET
- Conditions
- Esketamine, Postpartum Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 336 participants (actual)
- Lead sponsor
- Ailin LuoUniversity, hospital or other
- Collaborators
- Maternal and Child Health Hospital of Hubei Province, Jingmen No.1 People's Hospital
- Study start
- 1 May 2021 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 27 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was to explore the preventive effect of esketamine on postpartum depression (PPD) in cesarean section, and to evaluate the safety of the drug
Detailed description
Studies have shown that esketamine can treat clinical refractory depression, the drug takes effect quickly, can quickly eliminate the patient's suicide intention, low-dose maintenance treatment is conducive to the stability of the patient's condition, and less adverse reactions, is the current hot spot of antidepressant drug research. Esketamine has been approved by FDA for the treatment of refractory and suicidal depression, but can it effectively prevent and treat postpartum depression? It is not clear. Based on this, this study aims to explore the preventive effect of prophylactic administration of esketamine on postpartum depression in cesarean section, and evaluate the safety of the drug.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The incidence of PPD: the EPDS scale was assessed by face-to-face or telephone interview of the Puerpera 7 d, 30 d, 60 d and 90 d after delivery. EPDS score ≥ 10 was defined as antenatal depression or postpartum emotional disorder.
| Arm | Type | Receives |
|---|---|---|
| N group | Placebo comparator | Drug: Normal saline15 minutes after umbilical cord amputation, the patient was intravenously injected with 10 ml normal saline |
| Es group | Experimental | Drug: Esketamine15 minutes after umbilical cord amputation, the patient was intravenously injected with 0.25mg/kg esketamine, PCIA regimen: sufentanil 100 μ g, esketamine 80 mg, diluted to 100 ml with 0.9% normal saline, set analgesia pump background infusion dose 2 ml/h, single bolus dose 2 ml, locking time 8 minutes. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Elective cesarean section;
- 18-40 years;
- Primipara;
- Singleton pregnancy;
- Sign informed consent.
Key exclusion criteria (12 listed)
- American Society of Anesthesiologists (ASA) grade III and above;
- Intracranial hypertension;
- Hypertension;
- Severe heart disease;
- Hyperthyroidism patients without treatment or insufficient treatment;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EsketamineAlso: Es groupAfter delivery, the parturient was given a loading dose of esketamine, and then a small dose of esketamine was added into PCIA analgesia pump | Drug | Es group |
| Normal salineAlso: Ns group10 ml normal saline | Drug | N group |
Primary outcome
Edinburgh Postnatal Depression Scale(EPDS） scores
Time frame: up to 90 days after surgery
EPDS score is 0-30，and ≥ 10 to indicate depression
3 secondary outcomes
Numeric Rating Scale (NRS) score
Time frame: 1 Day before operation
total number of patient-controlled analgesia (PCA) compressions
Time frame: up to 24 hours after operation
total volume of PCA
Time frame: up to 24 hours after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 41607308Chu T, Peng X, Wan K, Li M, Liu T, Shi X, Yao W, Li S, Zhou Z, Yang C, Xu H, Kong J, Wang C, Cheng J, Xu Z, Li D, Liu X, He J, Ye X, Luo A, Xu A, Gao F. Prophylactic esketamine to reduce postpartum depression in primiparae: A multicentre, double-blind, randomised clinical trial. Eur J Anaesthesiol. 2026 Jul 1;43(7):584-593. doi: 10.1097/EJA.0000000000002348. Epub 2026 Jan 28.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ailin luo, Dr. principal investigator
Department of Anesthesiology of Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Esketamine and Normal saline in people with Esketamine and Postpartum Depression, run by Ailin Luo at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Edinburgh Postnatal Depression Scale(EPDS） scores (time frame: up to 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04860661, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.