The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy

This parallel assignment, single-blind clinical trial (n=396), aims to evaluate the effectiveness and safety of esketamine injection in modified electroconvulsive therapy (MECT) for depressive patients.

The study, led by the First Affiliated Hospital of Chongqing Medical University, is designed as a multicenter, randomized, controlled trial involving patients receiving MECT for the first time. The research drug, esketamine injection, will be administered at a dose of 17.5mg/70kg in the experimental group, while the control group will receive a saline injection at a dose of 3.5ml/70kg.

The primary outcome measure is the relief rate of depressive symptoms after MECT treatment, defined as two consecutive HDRS-24 scores ≤ 10 points. Secondary outcome measures include HDRS-24 scores after each MECT session, treatment response rate, severe suicidal tendency elimination rate, treatment re-ignition rate, treatment recurrence rate, and changes in cognitive function assessed by the Montreal Cognitive Scale (MoCA).

The study is expected to enrol 396 participants aged 16 to 45 years, with estimated completion in December 2022.

Trial Details

A multicenter, randomized, controlled, single blind clinical trial on the efficacy and safety of esmketamine injection in electroconvulsive therapy Objective to evaluate the efficacy and safety of esmketamine injection in the treatment of non convulsive electroconvulsive therapy Participants: Patients with depression receiving MECT The research drug was esketamine injection The study design was a multicenter, randomized, single blind, parallel controlled trial 25 mg / kg as the experimental group. The normal saline group was the control group (0.05 ml / kg). The sample size was estimated according to the main efficacy index (remission rate) of this study. It was assumed that the remission rate of the esketamine injection group was better than that of the control group. The parameters were set as test level α = 0.05, unilateral, β = 0.8, the cut-off value was 6%, the experimental group: the control group was 1:1, according to the results of previous clinical trials and combined with literature, the remission rate of the control group was 69%, 159 cases in each group, considering the 20% shedding rate, 198 cases in the experimental group and 198 cases in the control group were selected. - 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 - In the control group The patients were given 0.05ml/kg of normal saline, 1.5mg/kg of propofol and 1mg / kg of succinylcholine. After anesthesia, the patients were given electroconvulsive therapy Efficacy evaluation 1. Main efficacy indicators Remission rate of depressive symptoms after MECT treatment Remission was defined as two consecutive hdrs-24 scores ≤ 10 after receiving MECT Definition rate of remission rate: the proportion of patients with remission of depressive symptoms in this group

Trial Number NCT04777110

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.