Ignite Creation Date:
2024-05-06 @ 3:51 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04777110
Status:
UNKNOWN
Last Update Posted:
2021-07-20
First Post:
2021-02-22
Brief Title:
The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy
Sponsor:
First Affiliated Hospital of Chongqing Medical University
Organization:
First Affiliated Hospital of Chongqing Medical University
Study Overview
Official Title:
The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy for Depressive Patients-- A Multi-center Randomized Single-blind Clinical Study
Status:
UNKNOWN
Status Verified Date:
2021-07
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 005 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 005 unilateral β 08 the cut-off value was 6 the experimental group the control group was 11 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 025 mg kg esketamine 15 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 005mlkg of normal saline 15mgkg 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
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 005 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 005 unilateral β 08 the cut-off value was 6 the experimental group the control group was 11 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 025 mg kg esketamine 15 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 005mlkg of normal saline 15mgkg 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None