The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy

Study Overview
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Brief Summary
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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

Official Title
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The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy for Depressive Patients-- A Multi-center, Randomized , Single-blind Clinical Study

Conditions
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Esketamine, ECT, Depression

Intervention / Treatment
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* Drug: Esketamine
* Other: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Depressed patients receiving MECT for the first time; 16≤age≤45 years old, no gender limit; The ASA score is I or II; Meet the diagnostic criteria for depression established by APA, and the Hamilton Depression Rating Scale (HDRS-24) score ≥ 35 points; The depressive episode lasts at least 2 weeks; Clearly understand and voluntarily participate in the study, and sign an informed consent form. Exclusion Criteria: Combined with serious physical diseases, such as uncontrolled hypertension, coronary heart disease, intracranial vascular malformations, asthma attacks, severe liver and kidney dysfunction, etc. There are foreign bodies in the body: such as pacemakers, intracranial electrodes, etc. Those with a history of epilepsy Those who are taking reserpine Acute and systemic infectious diseases, moderate or higher fever History of manic episodes Those who are allergic to anesthetics and muscle relaxants Pregnant women Glaucoma Bipolar disorder, or other mental illnesses, mental retardation Those who judged by the physician in charge to be unsuitable for MECT treatment History of drug abuse

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esketamine injection group (0.25mg/kg)<br>The main anesthesiologist standing on the right side of the patient gave successive injections of esketamine (0.25 mg/kg), and 1 minute later, injected propofol (1.5 mg/kg) for 30 s | Drug: Esketamine<br>* The main anesthesiologist standing on the right side of the patient injects esketamine (0.25 mg/kg) sequentially, and then propofol (1.5 mg/kg) is injected 1 minute later for 30 s;<br>|
| Sham Comparator: Saline injection group(0.05ml/kg)<br>The main anesthesiologist standing on the right side of the patient sequentially injects normal saline (0.05ml/kg), and 1 minute later injects propofol (1.5 mg/kg), the injection time is 30 seconds | Other: Saline<br>* The main anesthesiologist standing on the right side of the patient injects saline (0.05ml/kg) sequentially, and then propofol (1.5 mg/kg) is injected 1 minute later, the injection time is 30 s<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relief rate of depressive symptoms after MECT treatment | After the patient received MECT treatment, the HDRS-24 score ≤ 10 points for two consecutive times | immediately after the end of each ECT procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDRS-24 score after each MECT | HDRS-24 score after each MECT | Immediately after the end of ECT, four months and six months after the end of the entire treatment course | 
| Treatment response rate | Response is defined as two consecutive HDRS-24 scores ≤ 50% before treatment after receiving MECT treatment. Effectiveness is defined as the proportion of patients in the group that are treated effectively | through treatment completion, an average of 18 days | 
| Severe suicidal tendency elimination rate | Severe suicidal tendency is defined as the suicide item score in HDRS-24 ≥ 3 points. The elimination rate of severe suicidal tendency was defined as the proportion of patients with suicide score=0 after treatment in the proportion of patients with severe suicidal tendency | through treatment completion, an average of 18 days | 
| Treatment re-ignition rate | Re-ignition is defined as an increase in HDRS-24 score of ≥ 10 points within 4 months of patients in remission. The re-ignition rate is defined as the proportion of re-ignition patients in remission patients. | within 4 months of patients in remission | 
| Treatment recurrence rate | The HDRS-24 score increased by ≥10 points after 4 months for patients whose recurrence is positioned as remission. The recurrence rate is defined as the proportion of relapsed patients in remission. | up to 4 months | 
| Changes in cognitive function | Montreal Cognitive Scale (MoCA) assessment | Immediately after the end of ECT, four months and six months after the end of the entire treatment course |