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

RecruitingEARLY Phase 1Ages 13 Years - 17 YearsAllMin Su
NCT07247968 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

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 ฮฑ=0.05 and a test power of ฮฒ=0.2,with a 1:1 ratio of sample sizes between the two groups,the total sample size was calculated to be 198 u

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๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Esketamine injection group (0.25 mg/kg)
  • Saline injection group (Consistent with esketamine injection volume)
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Where

2 sites
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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