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Esketamine and Perioperative Depressive Symptoms | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

Esketamine and Perioperative Depressive Symptoms

Effect of Esketamine on Perioperative Depressive Symptoms in Patients Undergoing Major Surgery

NCT04425473•Beijing Tiantan Hospital

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, China

Key Dates

Start Date

February 19, 2021

Primary Completion Date

June 23, 2024

Completion Date

November 27, 2024

Last Updated

August 1, 2025

Enrollment

435

ACTUAL participants

Conditions

Depressive SymptomsEsketaminePerioperative ComplicationMajor Surgery

Interventions

Esketamine

DRUG

Normal saline

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Esketamine and Perioperative Depressive Symptoms

Inclusion Criteria

Exclusion Criteria

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