The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy

NCT ID: NCT02066077

Last Updated: 2018-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-01

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Bilateral frontal and propofol

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Bilateral frontal MECT

Intervention Type DEVICE

Bilateral frontal and etomidate

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

Group Type EXPERIMENTAL

Etomidate

Intervention Type DRUG

Bilateral frontal MECT

Intervention Type DEVICE

Standard-therapy Group

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

Group Type ACTIVE_COMPARATOR

Etomidate

Intervention Type DRUG

Bilateral temporal MECT

Intervention Type DEVICE

Bilateral temporal and propofol

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

Bilateral temporal MECT

Intervention Type DEVICE

Bilateral temporal and etomidate

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

Group Type EXPERIMENTAL

Etomidate

Intervention Type DRUG

Bilateral temporal MECT

Intervention Type DEVICE

The right temporal and propofol

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

Group Type EXPERIMENTAL

Propofol

Intervention Type DRUG

The right temporal MECT

Intervention Type DEVICE

The right temporal and etomidate

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

Group Type EXPERIMENTAL

Etomidate

Intervention Type DRUG

The right temporal MECT

Intervention Type DEVICE

Interventions

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Etomidate

Intervention Type DRUG

Propofol

Intervention Type DRUG

Bilateral temporal MECT

Intervention Type DEVICE

The right temporal MECT

Intervention Type DEVICE

Bilateral frontal MECT

Intervention Type DEVICE

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tongji Hospital

OTHER

Sponsor Role collaborator

Huashan Hospital

OTHER

Sponsor Role collaborator

Shanghai Mental Health Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Shanghai Mental Health Center

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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SHDC12012109

Identifier Type: -

Identifier Source: org_study_id

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