The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy

NCT04777110 | Unknown Early Phase 1

• 1 other identifier: ESK-ECT20210222
• Study Type: interventional
• Target: 396
• Locations: 0 countries
• Sites: N/A

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. 1.experimental group
2. 2.In the control group

Conditions

Esketamine; ECT; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

  through treatment completion, an average of 18 days

• Severe suicidal tendency elimination rate

  through treatment completion, an average of 18 days

• Treatment re-ignition rate

  within 4 months of patients in remission

• Treatment recurrence rate

  up to 4 months

Study Arms (2)

Esketamine injection group (0.25mg/kg)

EXPERIMENTAL

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

Saline injection group(0.05ml/kg)

SHAM COMPARATOR

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

Interventions

Esketamine 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;

Esketamine injection group (0.25mg/kg)

Saline 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

Saline injection group(0.05ml/kg)

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Depressed patients receiving MECT for the first time;
• ≤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.

You may not qualify if:

• 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
• Glaucoma
• 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

Sponsors & Collaborators

• First Affiliated Hospital of Chongqing Medical University: lead

MeSH Terms

Conditions

Depression

Interventions

Esketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Anesthesiology, The First Affiliated Hospital of Chongqing Medical University

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 2, 2021
• Study Start: August 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 20, 2021

Record last verified: 2021-07