Low-dose esketamine with modified ECT for severe adolescent depression

Clinical and Mechanistic Study of Subanesthetic-dose Esketamine in Modified Electroconvulsive Therapy for Adolescents With Severe Depression

This trial will test whether adding a low dose of esketamine to modified electroconvulsive therapy helps treat severe depression in adolescents aged 13–17 and whether it is safe.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 220 (estimated)
• Ages: 13 Years to 17 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Chongqing Medical University (Academic / other)
• Locations: 2 sites (Chongqing and 1 other locations)
• Trial ID: NCT07247968 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, parallel-controlled early-phase 1 trial comparing a single subanesthetic dose of esketamine (0.25 mg/kg) versus saline given with modified electroconvulsive therapy (MECT) in adolescent inpatients. About 220 participants aged 13–17 will be enrolled and randomized 1:1, with sample size powered on expected differences in remission rates. Clinical outcomes such as response and remission rates and safety/tolerability will be measured, and the protocol includes collection of mechanistic data to explore how esketamine may alter treatment effects. Treatments are delivered during inpatient MECT sessions with standard anesthetic precautions and monitoring.

Who should consider this trial

Good fit: Ideal candidates are inpatients aged 13–17 with ICD-11 major depressive disorder who are scheduled for modified ECT, meet ASA I–II criteria, can complete study assessments, and provide informed consent.

Not a fit: Patients unlikely to benefit include those with severe cardiovascular or cerebrovascular disease, significant arrhythmias, recent ECT within 6 months, substance abuse history, or contraindications to anesthetic agents used in the protocol.

Why it matters

Potential benefit: If successful, adding low-dose esketamine could increase remission rates and speed recovery for adolescents receiving ECT for severe depression.

How similar studies have performed: Adult studies of ketamine or esketamine combined with ECT have reported faster or higher response rates in some reports, but randomized data in adolescents are limited and this approach remains incompletely tested in youth.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Chongqing and 1 other locations

• The First Affiliated Hospital of Chongqing Medical University — Chongqing, China (Not_yet_recruiting)
• The First Affiliated Hospital of Chongqing Medical University — Chongqing, China (Recruiting)

Study contacts

• Principal investigator: Su Min — First Affiliated Hospital of Chongqing Medical University
• Study coordinator: Xiaoge Han, Master

Conditions Esketamine; ECT; Depression; Adolescent