Low-dose esketamine with modified ECT for severe adolescent depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• The First Affiliated Hospital of Chongqing Medical University
  Chongqing, China Recruiting
• The First Affiliated Hospital of Chongqing Medical University
  Chongqing, China Not yet recruiting

Study contacts

• Principal investigator: Su Min — First Affiliated Hospital of Chongqing Medical University
• Study coordinator: Xiaoge Han, Master
• Email: 3164233689@qq.com
• Phone: 023-89011061

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.