Status:
COMPLETED
Esketamine and Perioperative Depressive Symptoms
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Depressive Symptoms
Esketamine
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Perioperative depressive symptoms (PDS) are common in population undergoing surgery, and this would be sharpened especially for complicated, high-risk major surgery. However, None of treatments could ...
Eligibility Criteria
Inclusion
- Patient undergoing elective major surgery
- Ages between 18 and 65 years old
- Moderate to severe depressive symptoms ( the Patient Health Questionnaire-9 scores equal to or more than 10 and Montgomery-Åsberg Depression Rating Scale scores equal to or more than 22 )
- Signed informed consent
Exclusion
- had aphasia or any conditions that prevented mental health assessments,
- had a history of psychotic or bipolar disorder,
- had a comorbidity that affected hormone levels,
- required prolonged postoperative mechanical ventilation,
- had received treatment with antidepressants within 2 weeks prior to the screening,
- had a body mass index greater than 30 kg/m2 and a Child-Pugh score greater than 6 points.
- had made repeated suicide attempts (as assessed by the 12-item Quick Inventory of Depressive Symptomatology scores less than 3),
- had experienced adverse reactions to ketamine or esketamine,
- had known drug use disorders,
- pregnant or breastfeeding
Key Trial Info
Start Date :
February 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2024
Estimated Enrollment :
435 Patients enrolled
Trial Details
Trial ID
NCT04425473
Start Date
February 19 2021
End Date
November 27 2024
Last Update
August 1 2025
Active Locations (1)
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1
Beijing Tiantan Hospital, Capital Medical University
Beijing, China, 100070