The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy

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

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.

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 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

Study Overview

• Status: Not yet recruiting
• Conditions: Depression; Esketamine; ECT
• Intervention / Treatment: Drug: Esketamine; Other: Saline

• Study Type: Interventional
• Enrollment (Anticipated): 396
• Phase: Early Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Depressed patients receiving MECT for the first time;
2. 16≤age≤45 years old, no gender limit;
3. The ASA score is I or II;
4. Meet the diagnostic criteria for depression established by APA, and the Hamilton Depression Rating Scale (HDRS-24) score ≥ 35 points;
5. The depressive episode lasts at least 2 weeks;
6. Clearly understand and voluntarily participate in the study, and sign an informed consent form.

Exclusion Criteria:

1. Combined with serious physical diseases, such as uncontrolled hypertension, coronary heart disease, intracranial vascular malformations, asthma attacks, severe liver and kidney dysfunction, etc.
2. There are foreign bodies in the body: such as pacemakers, intracranial electrodes, etc.
3. Those with a history of epilepsy
4. Those who are taking reserpine
5. Acute and systemic infectious diseases, moderate or higher fever
6. History of manic episodes
7. Those who are allergic to anesthetics and muscle relaxants
8. Pregnant women
9. Glaucoma
10. Bipolar disorder, or other mental illnesses, mental retardation
11. Those who judged by the physician in charge to be unsuitable for MECT treatment
12. History of drug abuse

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Esketamine injection group (0.25mg/kg); 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; 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;
Sham Comparator: Saline injection group(0.05ml/kg); 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; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Chongqing Medical University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): August 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: February 22, 2021
• First Submitted That Met QC Criteria: February 27, 2021
• First Posted (Actual): March 2, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2021
• Last Update Submitted That Met QC Criteria: July 18, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression; Psychotropic Drugs; Antidepressive Agents; Esketamine
• Other Study ID Numbers: ESK-ECT20210222

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No