The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy

Sponsor

Shanghai Mental Health Center (Other)

Overall Status

Completed

CT.gov ID

NCT02066077

Collaborator

Tongji Hospital (Other), Huashan Hospital (Other)

280

Enrollment

Location

Arms

Duration (Months)

4.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Major Depressive Disorder	Drug: Etomidate Drug: Propofol Device: Bilateral temporal MECT Device: The right temporal MECT Device: Bilateral frontal MECT	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

280 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy: A Randomized Clinical Trial And Its Standard Technology Promotion Research

Study Start Date :

Jan 1, 2013

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Dec 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bilateral temporal and propofol During the MECT treatment, electrodes are placed at bilateral temporal, with propofol 2mg/kg to Induce anesthesia.	Drug: Propofol Device: Bilateral temporal MECT
Experimental: Bilateral temporal and etomidate During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia.	Drug: Etomidate Device: Bilateral temporal MECT
Experimental: The right temporal and propofol During the MECT treatment, electrodes are placed at the right temporal, with propofol 2mg/kg to Induce anesthesia.	Drug: Propofol Device: The right temporal MECT
Experimental: The right temporal and etomidate During the MECT treatment, electrodes are placed at the right temporal, with etomidate 0.3mg/kg to Induce anesthesia.	Drug: Etomidate Device: The right temporal MECT
Experimental: Bilateral frontal and propofol During the MECT treatment, electrodes are placed at bilateral frontal, with propofol 2mg/kg to Induce anesthesia.	Drug: Propofol Device: Bilateral frontal MECT
Experimental: Bilateral frontal and etomidate During the MECT treatment, electrodes are placed at bilateral frontal, with etomidate 0.3mg/kg to Induce anesthesia.	Drug: Etomidate Device: Bilateral frontal MECT
Active Comparator: Standard-therapy Group During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia.	Drug: Etomidate Device: Bilateral temporal MECT

Outcome Measures

Primary Outcome Measures

Change in Hamilton Depression Scale(HAMD) Scores [Change from Baseline in Hamilton Depression Scale scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session]
Change in Wechsler Memory Scale (WMS) Scores as a Measure of Safety [Change from Baseline in Wechsler Memory Scale (WMS) Scores at 42d and 180d after the last MECT session]

Secondary Outcome Measures

Young Manic Rating Scale(MMSE) as a Measure for Evaluation of Mania State [42d and 180d after the last MECT session]
Resting-state/Task-state functional magnetic resonance imaging (fMRI) [Change form Baseline in Resting-state/Task-state fMRI Imging Results at 42d and 180d after the last MECT session]
Change in Hamilton Anxiety Scale(HAMA) Scores [Change from Baseline in Hamilton Anxiety Scale Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session]
Change in Clinical Global Impression-severity of illness(CGI-SI) Scores as a Measure of Efficacy [Change from Baseline in CGI-SI Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session]
Change in Wisconsin Card Sorting Test(WCST) Scores as a Measure of Safety [Change from Baseline in Wisconsin Card Sorting Test(WCST) Scores at 42d and 180d after the last MECT session]
Change in P300/P50 Event-Related Potentials(ERP) [Change from Baseline in P300/P50 Event-Related Potentials(ERP) at 42d and 180d after after the last MECT session]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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