Major Depressive Disorder
Conditions
Keywords
Major Depressive Disorder, Modified Electroconvulsive Therapy, Cognition, Memory
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.
Interventions
DRUGEtomidate
DRUGPropofol
DEVICEBilateral temporal MECT
DEVICEThe right temporal MECT
DEVICEBilateral frontal MECT
Sponsors
Tongji Hospital
Huashan Hospital
Shanghai Mental Health Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| Young Manic Rating Scale(MMSE) as a Measure for Evaluation of Mania State | 42d and 180d after the last MECT session |
| 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 |
| 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 |
| 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 |
Countries
China
Outcome results
None listed