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Investigating the effectiveness of esketamine in reducing depression for breast cancer patients after surgery

A randomized, double-blind, controlled trial to evaluate the effect of esketamine on postoperative depressive symptoms in breast cancer patients undergoing modified radical mastectomy (Esketamine in Breast Cancer-Depression Randomized Trial)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12578022
Enrollment
123
Registered
2024-08-25
Start date
2020-07-01
Completion date
Unknown
Last updated
2024-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer with postoperative depressive symptoms Cancer

Interventions

This randomized, double-blind, controlled trial enrolled 108 breast cancer patients who underwent modified radical mastectomy between July 2020 and March 2023. All patients were assessed with the Hami

Sponsors

The First Affiliated Hospital of University of South China
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. HAMD-17 score between 8 and 24 (mild to severe depressive symptoms) 2. Age range between 18 and 65 years 3. American Society of Anesthesiologists (ASA) physical status classification of I-II 4. Confirmed diagnosis of breast cancer and planned unilateral radical mastectomy for breast cancer

Exclusion criteria

Exclusion criteria: 1. HAMD-17 score of greater than 24 or less than 7 2. Other psychiatric disorders (e.g., schizophrenia and bipolar disorder) 3. History of psychiatric disorders prior to the study 4. Patients who have used psychotropic medications or have other serious systemic illnesses (including serious heart, kidney, or liver disease) 5. Contraindication or allergy to the use of esketamine 6. Planned surgery other than radical mastectomy alone (e.g., reconstruction)

Design outcomes

Primary

MeasureTime frame
Hamilton Depression Scale (HAMD-17) scores at baseline and 6 months postoperatively

Secondary

MeasureTime frame
1. HAMD-17 score changes at baseline (pre-surgery) and 6 months post-surgery 2. Patient demographic data (age, weight, height, pathology type)measured by review of patient medical records at the time of enrollment

Countries

China

Contacts

Public ContactHaifan Xu
3287917718@qq.com+86 15932910750

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026