The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02066077
• Other study ID #: SHDC12012109
• Status: Completed
• Phase: N/A
• First received: February 13, 2014
• Last updated: April 19, 2018
• Start date: January 1, 2013
• Est. completion date: December 31, 2017

Study information

• Verified date: December 2017
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Etomidate

• Propofol

Device:
• Bilateral temporal MECT

• The right temporal MECT

• Bilateral frontal MECT

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Mental Health Center	Huashan Hospital, Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Young Manic Rating Scale(MMSE) as a Measure for Evaluation of Mania State		42d and 180d after the last MECT session
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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