Esketamine and Perioperative Depressive Symptoms

Phase 2

Completed

• Conditions: Major Surgery; Perioperative Complication; Depressive Symptoms; Esketamine
• Interventions: Drug: Normal saline; Drug: Esketamine

• Registration Number: NCT04425473
• Lead Sponsor: Beijing Tiantan Hospital

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 resolve this clinical problem during limited perioperative period. The remarkable effects of ketamine on treatment resistant depression have been verified by several clinical trials and the enantiomer S-ketamine (esketamine) showed similar antidepressant efficacy with better safety in recent studies. The efficacy and safety of esketamine administrated intra-operatively for PDS will be verified in this study. Other secondary outcomes such as anxiety, postoperative pain and psychiatric symptoms will also be investigated.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2021-02-19
• Primary Completion: 2024-06-23
• Study Completion: 2024-11-27
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-31
• Last Update Posted: 2025-08-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 435

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Normal saline	-
Esketamine	Esketamine	-

Primary Outcome Measures

Name	Time	Method
Depressive symptoms remission	Postoperative 3-day	Remission is defined as the Montgomery-Åsberg Depression Rating Scale (MADRS) total score no more than 10, MADRS is a sensitive tool used for tracking improvement or progression in patients with major depressive disorder, consisting of 10 items that jointly assess the degree of depressive symptoms.

Secondary Outcome Measures

Name	Time	Method
MADRS scores	Postoperative 3-day	The differences in MADRS scores
Side-effects and Adverse events	During surgery or up to 7 days after surgery	All drug-related adverse events during surgery or before discharge
Depressive symptoms response	Postoperative 3-day	The rates of patients achieving a response
Moderate-to-severe pain	postoperative 3-day	The rate of severe pain after surgery
Long-term patient outcome	1, 3, and 6 months after surgery	The long-term patient outcomes included depressive symptoms and disability as measured by the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) at 1, 3, and 6 months after surgery.

Trial Locations

Locations (1)

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, China