The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy

Shanghai Mental Health Center

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Drug: Propofol; Drug: Etomidate; Device: The right temporal MECT; Device: Bilateral temporal MECT; Device: Bilateral frontal MECT

Study type: Interventional

Funder types: Other

Identifiers

NCT02066077

SHDC12012109

Details and patient eligibility

About

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.

Enrollment: 280 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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280 participants in 7 patient groups

Bilateral temporal and propofol

Experimental group

Description:

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

Treatment:

Drug: Propofol

Device: Bilateral temporal MECT

Bilateral temporal and etomidate

Experimental group

Description:

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

Treatment:

Device: Bilateral temporal MECT

Drug: Etomidate

The right temporal and propofol

Experimental group

Description:

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

Treatment:

Drug: Propofol

Device: The right temporal MECT

The right temporal and etomidate

Experimental group

Description:

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

Treatment:

Drug: Etomidate

Device: The right temporal MECT

Bilateral frontal and propofol

Experimental group

Description:

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

Treatment:

Drug: Propofol

Device: Bilateral frontal MECT

Bilateral frontal and etomidate

Experimental group

Description:

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

Treatment:

Device: Bilateral frontal MECT

Drug: Etomidate

Standard-therapy Group

Active Comparator group

Description:

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

Treatment:

Device: Bilateral temporal MECT

Drug: Etomidate