DepressionPhase 4ESPOD-BINCT04303325

Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)

A Phase 4 study testing Esketamine and Saline Solution in people with Depression, run by China Medical University, China at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years, women only
Conditions the study is for: Depression
What is being tested?: Esketamine and Saline Solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 72 participants
Where: 1 siteChina
Study dates: 8 Oct 2021to 30 Dec 2024
Phase: Phase 4
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 65 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

At least18 years and pre-menopausal;
scheduled to undergo elective breast cancer operation;
American Society of Anaesthesiologists (ASA) risk classification I-II.
Montgomery-asberg Depression Rating Scale (MADRS) score ≥22

Who cannot join

Cognitive difficulties
Partial or complete gastrectomy
Previous esophageal surgery
Inability to conform to the study's requirements
Ongoing participation or participation in another study <1 month ago

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

the First Hospital of China Medical University
Shenyang, Liaoning, 110001
Wen-fei Tan, M.D.,Ph.D, 024-83283100, winfieldtan@hotmail.com
Recruiting

Other trials in China

About this study

This study is a prospective, randomized, controlled (randomized, parallel group, concealed allocation), double-blinded trial. All depression patients undergoing breast cancer operation will be randomized 1:1 to the treatment intervention with general anesthesia as an adjunct to esketamine or saline. The objective of the trial is to evaluate the postoperative depression、gut microbiota、bispectral index data of patients undergoing breast cancer operation with esketamine or saline.

Read the detailed description

For female patients, breast cancer patients have a high risk of developing depression, and approximately 20%-45% of breast cancer patients suffer from postoperative depression. Esketamine is an anesthetic in analgesia, and has presently become more and more popular for treating anti-depression, particularly for resistant depression.

Conditions: Depression
Being tested: Esketamine, Saline Solution
Keywords: depression, sleep deprivation, gut microbiota, bispectral index
Medical subject headings: Depression, Sleep Deprivation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EsketamineDrug
All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine 0.2mg/kg.
Saline SolutionDrug
All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline.

Study groups in NCT04303325
Study group	Role	What they receive
Control	Placebo comparator	All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline. Receives: Drug: Saline Solution
Esketamine	Active comparator	All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine. Receives: Drug: Esketamine

What is being measured

The primary outcome is the main question the study is designed to answer.

Montgomery-asberg Depression Rating Scale score
Changes of Montgomery-asberg Depression Rating Scale score
Measured: from baseline to postoperative 24 hours

Secondary outcomes (2)

Bispectral index
Changes of bispectral index data
Measured: from 8pm to 6am on the first postoperative night
Gut microbiota
changs of gut microbiota
Measured: from baseline to postoperative 72 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Oct 202130 Dec 2024

First posted11 Mar 2020
Study start8 Oct 2021
Primary completion30 Oct 2024 (estimated)
Study completion30 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DepressionStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Parallel Assignment
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 72 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04303325
Sponsor's protocol ID: 20200225
Acronym: ESPOD-BI
Status last verified: Jul 2024
First submitted: 6 Mar 2020
Last updated: 22 Jul 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depression trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)
ClinicalTrials.gov ID: NCT04303325
Acronym / sponsor ID: ESPOD-BI / 20200225
Conditions: Depression
Keywords: depression, sleep deprivation, gut microbiota, bispectral index
Phase: Phase 4
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 72 participants (estimated)
Lead sponsor: China Medical University, ChinaUniversity, hospital or other
Study start: 8 Oct 2021 (actual)
Primary completion: 30 Oct 2024 (estimated)
Study completion: 30 Dec 2024 (estimated)
First posted: 11 Mar 2020 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
Model description: Parallel Assignment

Arm	Type	Receives
Control	Placebo comparator	Drug: Saline SolutionAll depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline.
Esketamine	Active comparator	Drug: EsketamineAll depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine.

Who may qualify

Ages: 18 to 65 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

At least18 years and pre-menopausal;
scheduled to undergo elective breast cancer operation;
American Society of Anaesthesiologists (ASA) risk classification I-II.
Montgomery-asberg Depression Rating Scale (MADRS) score ≥22

Key exclusion criteria (5 listed)

Cognitive difficulties
Partial or complete gastrectomy
Previous esophageal surgery
Inability to conform to the study's requirements
Ongoing participation or participation in another study <1 month ago

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
EsketamineAll depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine 0.2mg/kg.	Drug	Esketamine
Saline SolutionAll depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline.	Drug	Control

Primary outcome

Montgomery-asberg Depression Rating Scale score
Time frame: from baseline to postoperative 24 hours
Changes of Montgomery-asberg Depression Rating Scale score

2 secondary outcomes

Bispectral index
Time frame: from 8pm to 6am on the first postoperative night
Gut microbiota
Time frame: from baseline to postoperative 72 hours

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2024.
Individual participant dataSharing planned: No

Related trials for Depression

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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.

the First Hospital of China Medical University

Shenyang, China

024-83283100

winfieldtan@hotmail.com

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Esketamine and Saline Solution in people with Depression, run by China Medical University, China 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Jul 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Montgomery-asberg Depression Rating Scale score (time frame: from baseline to postoperative 24 hours). 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 NCT04303325.

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 22 Jul 2024.