Esketamine and Perioperative Depressive Symptoms

NCT04425473 | Completed Phase 2 DMC

• 1 other identifier: Z191100006619067
• Study Type: interventional
• Target: 435
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Symptoms; Esketamine; Perioperative Complication; Major Surgery

Outcome Measures

Primary Outcomes (1)

• Depressive symptoms remission

  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.

  Postoperative 3-day

Secondary Outcomes (5)

• MADRS scores

  Postoperative 3-day

• Depressive symptoms response

  Postoperative 3-day

• Moderate-to-severe pain

  postoperative 3-day

• Side-effects and Adverse events

  During surgery or up to 7 days after surgery

• Long-term patient outcome

  1, 3, and 6 months after surgery

Study Arms (2)

Esketamine

EXPERIMENTAL

Drug: Esketamine

Placebo

PLACEBO COMPARATOR

Drug: Normal saline

Interventions

Esketamine DRUG

Esketamine will be administrated intravenously when suturing incision, with total dose of 0.2mg/kg and continuous infusion for 40 minutes.

Esketamine

Normal saline DRUG

Equivalent amount of normal saline will be administrated intravenously suturing incision.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, 100070, China

Location

Related Publications (1)

• Zhou Y, Ma B, Sun W, Wang J, Fu Y, Wang A, Wang G, Han R. Effect of esketamine on perioperative depressive symptoms in major surgery patients (PASSION II): study protocol for a randomised controlled trial. BMJ Open. 2022 Apr 26;12(4):e056713. doi: 10.1136/bmjopen-2021-056713.

  PMID: 35473735 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Esketamine; Saline Solution

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Ruquan Han, M.D., Ph D.

  Beijing Tiantan Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: February 19, 2021
• Primary Completion: June 23, 2024
• Study Completion: November 27, 2024
• Last Updated: August 1, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After the publication of the study results.
• Access Criteria: Publication in peer reviewed journal

Locations

CN (1)