The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy

NCT ID: NCT04777110

Last Updated: 2021-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 396 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-31
• Study Completion Date: 2022-12-31

Brief Summary

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

Conditions

Esketamine; ECT; Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Esketamine

Intervention Type: DRUG

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;

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

Group Type: SHAM_COMPARATOR

Saline

Intervention Type: OTHER

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

Interventions

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;

Intervention Type: DRUG

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Chongqing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Min Su

Director of Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

ESK-ECT20210222

Identifier Type: -

Identifier Source: org_study_id