The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy

N/ACompletedNCT02066077

Shanghai Mental Health Center280 enrolled

Overview

1. To determine the influencing factors of modified electroconvulsive therapy (MECT); 2. To determine the influencing factors and reversibility of the cognitive impairment caused by MECT; 3. To determine the duration of efficacy of MECT and its affecting factors.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

280

Conditions

Major Depressive Disorder

Interventions

EtomidateDRUG

PropofolDRUG

Bilateral temporal MECTDEVICE

The right temporal MECTDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Shanghai Mental Health Center

Shanghai, China

Outcomes

Primary Outcomes

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

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 Outcomes

Young Manic Rating Scale(MMSE) as a Measure for Evaluation of Mania State

Time frame: 42d and 180d after the last MECT session

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

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

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

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

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

Data from ClinicalTrials.gov

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