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The Effect of Esketamine on Depressive Symptoms in Breast Cancer Patients with Depression: a multicenter, double-blind, placebo-controlled, randomised clinical trial

The Effect of Esketamine on Depressive Symptoms in Breast Cancer Patients with Depression: a multicenter, double-blind, placebo-controlled, randomised clinical trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090873
Enrollment
Unknown
Registered
2024-10-14
Start date
2024-12-16
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

depression

Interventions

esketamine group :the esketamine group will receive 0.25 mg/kg of esketamine, diluted in 40 mL of saline and infused at a rate of 60 mL per hour over 40 minutes.
Placebo group:the placebo group will receive 40ml saline,infused at a rate of 60 mL per hour over 40 minutes.

Sponsors

Jiangsu Province People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women scheduled for elective unilateral breast cancer surgery; 2. Age = 18 years; 3. BDI-13 score = 5; 4. American Society of Anesthesiologists (ASA) grade I to III; 5. Ability to listen, speak, read, write, and communicate.

Exclusion criteria

Exclusion criteria: Contraindications or allergies to esketamine or other medications; Poorly controlled hypertension; Severe cardiac, hepatic, or renal dysfunction; Cerebrovascular diseases; History of psychiatric disorders; Long-term use of psychiatric medications, sedatives, analgesics, or antidepressants before surgery, sedatives, analgesics, or antidepressants

Design outcomes

Primary

MeasureTime frame
The incidence of moderate to severe depression on the first day postoperatively;

Secondary

MeasureTime frame
Response and remission rates on postoperative days 1, 7, and 14;Incidence of intraoperative hypotension and hypertension;NRS scores at 24 hours postoperatively;15-item Recovery Quality Scale score;Nausea ;vomiting;Other adverse reactions;

Countries

China

Contacts

Public ContactChun Yang

Jiangsu Province People's Hospital

dr.analgesia@qq.com+86 186 2781 6797

Outcome results

None listed

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