The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy

Early Phase 1UnknownNCT04777110

First Affiliated Hospital of Chongqing Medical University396 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex: ALLMin age: 16 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Relief rate of depressive symptoms after MECT treatment

After the patient received MECT treatment, the HDRS-24 score ≤ 10 points for two consecutive times

Time frame: immediately after the end of each ECT procedure

Secondary Outcomes

HDRS-24 score after each MECT

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: up to 4 months

Changes in cognitive function

Montreal Cognitive Scale (MoCA) assessment