Clinical trial NCT04777110: The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy
Official title: The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy for Depressive Patients-- A Multi-center, Randomized , Single-blind Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Esketamine
ECT
Depression
Lead sponsor: First Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2021-03-02
Enrollment: 396
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Relief rate of depressive symptoms after MECT treatment
timeFrame: immediately after the end of each ECT procedure
Secondary outcomes:
measure: HDRS-24 score after each MECT
timeFrame: Immediately after the end of ECT, four months and six months after the end of the entire treatment course
measure: Treatment response rate
timeFrame: through treatment completion, an average of 18 days
measure: Severe suicidal tendency elimination rate
timeFrame: through treatment completion, an average of 18 days
measure: Treatment re-ignition rate
timeFrame: within 4 months of patients in remission
measure: Treatment recurrence rate
timeFrame: up to 4 months
measure: Changes in cognitive function
timeFrame: Immediately after the end of ECT, four months and six months after the end of the entire treatment course
Other outcomes:
Locations:
Study officials:
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