- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02066077
The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy
April 19, 2018 updated by: Shanghai Mental Health Center
The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy: A Randomized Clinical Trial And Its Standard Technology Promotion Research
- 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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
280
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai, China
- Shanghai Mental Health Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bilateral temporal and propofol
During the MECT treatment, electrodes are placed at bilateral temporal, with propofol 2mg/kg to Induce anesthesia.
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Experimental: Bilateral temporal and etomidate
During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia.
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Experimental: The right temporal and propofol
During the MECT treatment, electrodes are placed at the right temporal, with propofol 2mg/kg to Induce anesthesia.
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Experimental: The right temporal and etomidate
During the MECT treatment, electrodes are placed at the right temporal, with etomidate 0.3mg/kg to Induce anesthesia.
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Experimental: Bilateral frontal and propofol
During the MECT treatment, electrodes are placed at bilateral frontal, with propofol 2mg/kg to Induce anesthesia.
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Experimental: Bilateral frontal and etomidate
During the MECT treatment, electrodes are placed at bilateral frontal, with etomidate 0.3mg/kg to Induce anesthesia.
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Active Comparator: Standard-therapy Group
During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Change from Baseline in Hamilton Depression Scale scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
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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
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Change from Baseline in Wechsler Memory Scale (WMS) Scores at 42d and 180d after the last MECT session
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Young Manic Rating Scale(MMSE) as a Measure for Evaluation of Mania State
Time Frame: 42d and 180d after the last MECT session
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42d and 180d after the last MECT session
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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
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Change form Baseline in Resting-state/Task-state fMRI Imging Results at 42d and 180d after the last MECT session
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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
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Change from Baseline in Hamilton Anxiety Scale Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
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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
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Change from Baseline in CGI-SI Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
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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
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Change from Baseline in Wisconsin Card Sorting Test(WCST) Scores at 42d and 180d after the last MECT session
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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
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Change from Baseline in P300/P50 Event-Related Potentials(ERP) at 42d and 180d after after the last MECT session
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
December 31, 2017
Study Completion (Actual)
December 31, 2017
Study Registration Dates
First Submitted
February 13, 2014
First Submitted That Met QC Criteria
February 16, 2014
First Posted (Estimate)
February 19, 2014
Study Record Updates
Last Update Posted (Actual)
April 23, 2018
Last Update Submitted That Met QC Criteria
April 19, 2018
Last Verified
December 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Neurocognitive Disorders
- Cognition Disorders
- Depression
- Depressive Disorder
- Cognitive Dysfunction
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Hypnotics and Sedatives
- Propofol
- Etomidate
Other Study ID Numbers
- SHDC12012109
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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