Subanesthetic Esketamine in Modified ECT for Severe Depression in Adolescents: Clinical and Mechanistic Study

NCT07247968 | Recruiting Early Phase 1

• 1 other identifier: Esketamine2025-629-01
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 2

Brief Summary

The study design was a randomized, double blind, parallel controlled trial.The goal of this clinical trial is to learn if esketamine-assisted modified electroconvulsive therapy (ESK-MECT) works to treat severe depression in adolescents. It will also learn about the safety of ESK-MECT. The sample size was calculated based on the response rate of patients with depression undergoing electroconvulsive therapy(ECT).According to the results of the pilot study,the efficacy rate of subjects receiving adjunctive esketamine was approximately 78%,while the efficacy rate of those receiving only propofol was 63%.The expected superiority difference in remission rates between the two groups was 15%(one-sided)for the power calculation.Assuming a significance level of α=0.05 and a test power of β=0.2,with a 1:1 ratio of sample sizes between the two groups,the total sample size was calculated to be 198 using the PASS software(PASS 2023).Considering a dropout rate of 10%,a total of 220 subjects were required,with 110 subjects in each group.

1. 1.experimental group The patients were given intravenous injection of 0.25 mg / kg esketamine, 1.5 mg / kg propofol and 1 mg / kg succinylcholine in turn. After anesthesia, the patients were given electroconvulsive therapy.
2. 2.In the control group The patients were given normal saline consistent with esketamine injection volume, 1.5mg/kg of propofol and 1mg / kg of succinylcholine. After anesthesia, the patients were given electroconvulsive therapy.

Conditions

Esketamine; ECT; Depression; Adolescent

Outcome Measures

Primary Outcomes (1)

• Treatment response rate

  Response is defined as two consecutive HAMD-24 scores ≤ 50% before treatment after receiving MECT treatment. The response rate is calculated as the number of patients who achieved as response divided by the total number of patients receiving MECT.In this study, the 24-item version of HAMD was utilized.

  immediately after the end of each MECT procedure

Secondary Outcomes (5)

• Remission rate of depressive symptoms after MECT treatment

  immediately after the end of each MECT procedure

• Changes in cognitive function

  Immediately after the end of MECT course

• The remission rate of suicidal ideation

  through treatment completion, an average of 18 days

• Changes in psychiatric symptoms

  Immediately after the end of MECT course

• Wechsler Memory Scale-Chinese-Revision

  Immediately after the end of MECT course

Study Arms (2)

Esketamine injection group (0.25mg/kg)

EXPERIMENTAL

The main anesthesiologist standing on the right side of the patient gave successive injections of esketamine (0.25 mg/kg), and 1 minute later, injected propofol (1.5mg/kg) for 30 s.After the loss of consciousness, all patients were administered 1 mg/kg of succinylcholine chloride and manually ventilated with a face mask until they regained full consciousness.

Drug: Esketamine injection group (0.25 mg/kg)

Saline injection group(Consistent with esketamine injection volume)

SHAM COMPARATOR

The main anesthesiologist standing on the right side of the patient gave successive injections of saline (Consistent with esketamine injection volume), and 1 minute later, injected 1.5mg/kg of propofol in 30s.After the loss of consciousness,all patients were administered 1 mg/kg of succinylcholine chloride and manually ventilated with a face mask until they regained full consciousness.

Other: Saline injection group (Consistent with esketamine injection volume)

Interventions

Esketamine injection group (0.25 mg/kg) DRUG

The main anesthesiologist standing on the right side of the patient injects esketamine (0.25 mg/kg) sequentially, and then propofol (1.5 mg/kg) is injected 1 minute later for 30 s.After the loss of consciousness,all patients were administered 1 mg/kg of succinylcholine chloride and manually ventilated with a face mask until they regained full consciousness.

Esketamine injection group (0.25mg/kg)

Saline injection group (Consistent with esketamine injection volume) OTHER

The main anesthesiologist standing on the right side of the patient injects saline (Consistent with esketamine injection volume) sequentially, and then propofol (1.5 mg/kg) is injected 1 minute later, the injection time is 30s.After the loss of consciousness,all patients were administered 1 mg/kg of succinylcholine chloride and manually ventilated with a face mask until they regained full consciousness.

Saline injection group(Consistent with esketamine injection volume)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Inpatients diagnosed with Major Depressive Disorder according to the International Classification of Diseases,11th Revision(ICD-11),and scheduled for Modified Electroconvulsive Therapy(MECT);
• Aged 13 to 17 years,regardless of gender;
• Educational attainment of primary school or higher;
• Normal hearing and vision,including color perception;
• Voluntary participation in the study with signed informed consent;
• American Society of Anesthesiologists(ASA)physical status classification I-II.

You may not qualify if:

• Severe cardiovascular disease,significant arrhythmias,or other cardiac conditions;
• Inability to complete the assessment scales;
• History of substance abuse;
• Received electroconvulsive therapy(ECT)within 6 months prior to the study;
• Severe cerebrovascular disease,severe hypertension,intracranial hypertension,or presence of intracranial electrodes;
• Severe allergy or contraindication to propofol or succinylcholine;
• Comorbid with other psychiatric disorders.

Sponsors & Collaborators

• Min Su: lead

Study Sites (2)

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

NOT YET RECRUITING

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

RECRUITING

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Su Min

  First Affiliated Hospital of Chongqing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaoge Han, Master

CONTACT

023-89011061; 3164233689@qq.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology

Study Record Dates

• First Submitted: September 24, 2025
• First Posted: November 25, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): November 20, 2026
• Study Completion (Estimated): December 20, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)