Esketamine's effects on depression and gut health in breast cancer surgery patients
Effect of Esketamine on Postoperative Depression、Gut Microbiota、Bispectral Index Data of Depression Patients Undergoing Breast Cancer Operation (ESPOD-BI)
This study is testing if esketamine can help reduce depression and improve gut health in women recovering from breast cancer surgery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | China Medical University, China Academic / other |
| Locations | 1 site (Shenyang, Liaoning) |
| Trial ID | NCT04303325 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effects of esketamine on postoperative depression, gut microbiota, and bispectral index data in female patients undergoing elective breast cancer surgery. Participants will be randomly assigned to receive either esketamine or saline as an adjunct to general anesthesia. The study aims to determine if esketamine can reduce the incidence of postoperative depression, which affects a significant percentage of breast cancer patients. The trial employs a double-blinded, controlled design to ensure unbiased results.
Who should consider this trial
Good fit: Ideal candidates are pre-menopausal female patients aged 18 and older scheduled for elective breast cancer surgery with a MADRS score of 22 or higher.
Not a fit: Patients with cognitive difficulties, previous esophageal surgery, or those unable to comply with study requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option to reduce postoperative depression in breast cancer patients.
How similar studies have performed: While the use of esketamine for depression is gaining traction, this specific application in the context of postoperative care for breast cancer patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Shenyang, Liaoning
- the First Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.