The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy for Depressive Patients-- A Multi-center, Randomized , Single-blind Clinical Study
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 396
- 主要终点
- Relief rate of depressive symptoms after MECT treatment
研究概览
简要总结
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 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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
研究组 & 干预措施
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
干预措施: Esketamine (Drug)
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
干预措施: Saline (Other)
结局指标
主要结局
Relief rate of depressive symptoms after MECT treatment
时间窗: immediately after the end of each ECT procedure
After the patient received MECT treatment, the HDRS-24 score ≤ 10 points for two consecutive times
次要结局
- Treatment re-ignition rate(within 4 months of patients in remission)
- Severe suicidal tendency elimination rate(through treatment completion, an average of 18 days)
- Treatment response rate(through treatment completion, an average of 18 days)
- Treatment recurrence rate(up to 4 months)
- Changes in cognitive function(Immediately after the end of ECT, four months and six months after the end of the entire treatment course)
- 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)
研究者
Min Su
Director of Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University
First Affiliated Hospital of Chongqing Medical University