---
title: Esketamine and Perioperative Depressive Symptoms
nct_id: NCT04425473
overall_status: COMPLETED
phase: PHASE2, PHASE3
sponsor: Beijing Tiantan Hospital
study_type: INTERVENTIONAL
primary_condition: Depressive Symptoms
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04425473.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04425473"
ct_last_update_post_date: 2025-08-01
last_seen_at: "2026-05-12T06:19:28.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Esketamine and Perioperative Depressive Symptoms

**Official Title:** Effect of Esketamine on Perioperative Depressive Symptoms in Patients Undergoing Major Surgery

**NCT ID:** [NCT04425473](https://clinicaltrials.gov/study/NCT04425473)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2, PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 435
- **Lead Sponsor:** Beijing Tiantan Hospital
- **Conditions:** Depressive Symptoms, Esketamine, Perioperative Complication, Major Surgery
- **Start Date:** 2021-02-19
- **Completion Date:** 2024-11-27
- **CT.gov Last Update:** 2025-08-01

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Esketamine** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **Esketamine** (DRUG) — Esketamine will be administrated intravenously when suturing incision, with total dose of 0.2mg/kg and continuous infusion for 40 minutes.
- **Normal saline** (DRUG) — Equivalent amount of normal saline will be administrated intravenously suturing incision.

## Primary Outcomes

- **Depressive symptoms remission** _(time frame: 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 Outcomes

- **MADRS scores** _(time frame: Postoperative 3-day)_
- **Depressive symptoms response** _(time frame: Postoperative 3-day)_
- **Moderate-to-severe pain** _(time frame: postoperative 3-day)_
- **Side-effects and Adverse events** _(time frame: During surgery or up to 7 days after surgery)_
- **Long-term patient outcome** _(time frame: 1, 3, and 6 months after surgery)_

## Locations (1)

- Beijing Tiantan Hospital, Capital Medical University, Beijing, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.beijing tiantan hospital, capital medical university|beijing||china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT04425473*  
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