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The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Etomidate
Propofol
Bilateral temporal MECT
The right temporal MECT
Bilateral frontal MECT
Sponsored by
Shanghai Mental Health Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Modified Electroconvulsive Therapy, Cognition, Memory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged over 18 years (when informed consent was got), male or female
  • Meet International Classification of Diseases-10(ICD-10) diagnostic criteria for depression
  • Scored 18 or above on the HAM-D Scale which included 17 items
  • Clinical Global Impression(CGI)-severity score ≥ 4
  • Provided written informed consent

Exclusion Criteria:

  • Any depressive disorders not due to major depressive disorder
  • Meet other diagnosis criteria in Diagnostic and Statistical Manual of Mental Disorders-IV-Test Revision(DSM-IV-TR) Axis I
  • With a history of acute or chronic renal failure, liver cirrhosis or active hepatopathy
  • With clinically significant abnormal results of laboratory test, which are considered to have impact on treatment efficacy and the safety of participants
  • With a history of severe or unstable physical disease including nervous system disease and myocardial infarction
  • Undergoing alcoholism or alcohol (or substance) abuse during 30 days or 6 months before the trial
  • With no response to previous ECT treatment
  • Received transcranial magnetic stimulation treatment in the last 6 months
  • Allergic to propofol, etomidate and succinylcholine chloride
  • During pregnancy or lactation
  • With a history of stroke in the last month
  • Enrolled in any other clinical trial 30 days prior to the baseline

Sites / Locations

  • Shanghai Mental Health Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Bilateral temporal and propofol

Bilateral temporal and etomidate

The right temporal and propofol

The right temporal and etomidate

Bilateral frontal and propofol

Bilateral frontal and etomidate

Standard-therapy Group

Arm Description

During the MECT treatment, electrodes are placed at bilateral temporal, with propofol 2mg/kg to Induce anesthesia.

During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia.

During the MECT treatment, electrodes are placed at the right temporal, with propofol 2mg/kg to Induce anesthesia.

During the MECT treatment, electrodes are placed at the right temporal, with etomidate 0.3mg/kg to Induce anesthesia.

During the MECT treatment, electrodes are placed at bilateral frontal, with propofol 2mg/kg to Induce anesthesia.

During the MECT treatment, electrodes are placed at bilateral frontal, with etomidate 0.3mg/kg to Induce anesthesia.

During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia.

Outcomes

Primary Outcome Measures

Change in Hamilton Depression Scale(HAMD) Scores
Change in Wechsler Memory Scale (WMS) Scores as a Measure of Safety

Secondary Outcome Measures

Young Manic Rating Scale(MMSE) as a Measure for Evaluation of Mania State
Resting-state/Task-state functional magnetic resonance imaging (fMRI)
Change in Hamilton Anxiety Scale(HAMA) Scores
Change in Clinical Global Impression-severity of illness(CGI-SI) Scores as a Measure of Efficacy
Change in Wisconsin Card Sorting Test(WCST) Scores as a Measure of Safety
Change in P300/P50 Event-Related Potentials(ERP)

Full Information

First Posted
February 13, 2014
Last Updated
April 19, 2018
Sponsor
Shanghai Mental Health Center
Collaborators
Tongji Hospital, Huashan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02066077
Brief Title
The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy
Official Title
The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy: A Randomized Clinical Trial And Its Standard Technology Promotion Research
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (undefined)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Mental Health Center
Collaborators
Tongji Hospital, Huashan Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To determine the influencing factors of modified electroconvulsive therapy (MECT); To determine the influencing factors and reversibility of the cognitive impairment caused by MECT; To determine the duration of efficacy of MECT and its affecting factors.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, Modified Electroconvulsive Therapy, Cognition, Memory

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilateral temporal and propofol
Arm Type
Experimental
Arm Description
During the MECT treatment, electrodes are placed at bilateral temporal, with propofol 2mg/kg to Induce anesthesia.
Arm Title
Bilateral temporal and etomidate
Arm Type
Experimental
Arm Description
During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia.
Arm Title
The right temporal and propofol
Arm Type
Experimental
Arm Description
During the MECT treatment, electrodes are placed at the right temporal, with propofol 2mg/kg to Induce anesthesia.
Arm Title
The right temporal and etomidate
Arm Type
Experimental
Arm Description
During the MECT treatment, electrodes are placed at the right temporal, with etomidate 0.3mg/kg to Induce anesthesia.
Arm Title
Bilateral frontal and propofol
Arm Type
Experimental
Arm Description
During the MECT treatment, electrodes are placed at bilateral frontal, with propofol 2mg/kg to Induce anesthesia.
Arm Title
Bilateral frontal and etomidate
Arm Type
Experimental
Arm Description
During the MECT treatment, electrodes are placed at bilateral frontal, with etomidate 0.3mg/kg to Induce anesthesia.
Arm Title
Standard-therapy Group
Arm Type
Active Comparator
Arm Description
During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia.
Intervention Type
Drug
Intervention Name(s)
Etomidate
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Type
Device
Intervention Name(s)
Bilateral temporal MECT
Intervention Type
Device
Intervention Name(s)
The right temporal MECT
Intervention Type
Device
Intervention Name(s)
Bilateral frontal MECT
Primary Outcome Measure Information:
Title
Change in Hamilton Depression Scale(HAMD) Scores
Time Frame
Change from Baseline in Hamilton Depression Scale scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
Title
Change in Wechsler Memory Scale (WMS) Scores as a Measure of Safety
Time Frame
Change from Baseline in Wechsler Memory Scale (WMS) Scores at 42d and 180d after the last MECT session
Secondary Outcome Measure Information:
Title
Young Manic Rating Scale(MMSE) as a Measure for Evaluation of Mania State
Time Frame
42d and 180d after the last MECT session
Title
Resting-state/Task-state functional magnetic resonance imaging (fMRI)
Time Frame
Change form Baseline in Resting-state/Task-state fMRI Imging Results at 42d and 180d after the last MECT session
Title
Change in Hamilton Anxiety Scale(HAMA) Scores
Time Frame
Change from Baseline in Hamilton Anxiety Scale Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
Title
Change in Clinical Global Impression-severity of illness(CGI-SI) Scores as a Measure of Efficacy
Time Frame
Change from Baseline in CGI-SI Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
Title
Change in Wisconsin Card Sorting Test(WCST) Scores as a Measure of Safety
Time Frame
Change from Baseline in Wisconsin Card Sorting Test(WCST) Scores at 42d and 180d after the last MECT session
Title
Change in P300/P50 Event-Related Potentials(ERP)
Time Frame
Change from Baseline in P300/P50 Event-Related Potentials(ERP) at 42d and 180d after after the last MECT session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged over 18 years (when informed consent was got), male or female Meet International Classification of Diseases-10(ICD-10) diagnostic criteria for depression Scored 18 or above on the HAM-D Scale which included 17 items Clinical Global Impression(CGI)-severity score ≥ 4 Provided written informed consent Exclusion Criteria: Any depressive disorders not due to major depressive disorder Meet other diagnosis criteria in Diagnostic and Statistical Manual of Mental Disorders-IV-Test Revision(DSM-IV-TR) Axis I With a history of acute or chronic renal failure, liver cirrhosis or active hepatopathy With clinically significant abnormal results of laboratory test, which are considered to have impact on treatment efficacy and the safety of participants With a history of severe or unstable physical disease including nervous system disease and myocardial infarction Undergoing alcoholism or alcohol (or substance) abuse during 30 days or 6 months before the trial With no response to previous ECT treatment Received transcranial magnetic stimulation treatment in the last 6 months Allergic to propofol, etomidate and succinylcholine chloride During pregnancy or lactation With a history of stroke in the last month Enrolled in any other clinical trial 30 days prior to the baseline
Facility Information:
Facility Name
Shanghai Mental Health Center
City
Shanghai
Country
China

12. IPD Sharing Statement

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The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy

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