The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Drug: Etomidate
* Drug: Propofol
* Device: Bilateral temporal MECT
* Device: The right temporal MECT
* Device: Bilateral frontal MECT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder, Modified Electroconvulsive Therapy, Cognition, Memory