Clinical trial NCT02066077: The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy
Official title: The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy: A Randomized Clinical Trial And Its Standard Technology Promotion Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Modified Electroconvulsive Therapy
Cognition
Memory
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
Collaborators: name: Tongji Hospital
name: Huashan Hospital
First posted: 2014-02-19
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Hamilton Depression Scale(HAMD) Scores
timeFrame: Change from Baseline in Hamilton Depression Scale scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
measure: Change in Wechsler Memory Scale (WMS) Scores as a Measure of Safety
timeFrame: Change from Baseline in Wechsler Memory Scale (WMS) Scores at 42d and 180d after the last MECT session
Secondary outcomes:
measure: Young Manic Rating Scale(MMSE) as a Measure for Evaluation of Mania State
timeFrame: 42d and 180d after the last MECT session
measure: Resting-state/Task-state functional magnetic resonance imaging (fMRI)
timeFrame: Change form Baseline in Resting-state/Task-state fMRI Imging Results at 42d and 180d after the last MECT session
measure: Change in Hamilton Anxiety Scale(HAMA) Scores
timeFrame: Change from Baseline in Hamilton Anxiety Scale Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
measure: Change in Clinical Global Impression-severity of illness(CGI-SI) Scores as a Measure of Efficacy
timeFrame: Change from Baseline in CGI-SI Scores at 7d, 14d, 21d, 28d, 35d, 42d and 180d after the last MECT session
measure: Change in Wisconsin Card Sorting Test(WCST) Scores as a Measure of Safety
timeFrame: Change from Baseline in Wisconsin Card Sorting Test(WCST) Scores at 42d and 180d after the last MECT session
measure: Change in P300/P50 Event-Related Potentials(ERP)
timeFrame: Change from Baseline in P300/P50 Event-Related Potentials(ERP) at 42d and 180d after after the last MECT session
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
Study officials:
References: