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

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. 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. 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. Effi…

This description comes directly from the study's public registry record.

Xiaoge Han, Master  ·  023-89011061  ·  3164233689@qq.com

Always discuss trial participation with your own doctor first.

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice.