The Efficacy And Cognitive Impairment Of Modified Electroconvulsive Therapy
Not Applicable
Completed
- Conditions
- Major Depressive Disorder
- Interventions
- Device: The right temporal MECTDevice: Bilateral temporal MECTDevice: Bilateral frontal MECT
- Registration Number
- NCT02066077
- Lead Sponsor
- Shanghai Mental Health Center
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 280
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The right temporal and etomidate The right temporal MECT During the MECT treatment, electrodes are placed at the right temporal, with etomidate 0.3mg/kg to Induce anesthesia. Bilateral temporal and propofol Bilateral temporal MECT During the MECT treatment, electrodes are placed at bilateral temporal, with propofol 2mg/kg to Induce anesthesia. Bilateral temporal and etomidate Etomidate During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia. Bilateral temporal and etomidate Bilateral temporal MECT During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia. The right temporal and propofol Propofol During the MECT treatment, electrodes are placed at the right temporal, with propofol 2mg/kg to Induce anesthesia. The right temporal and propofol The right temporal MECT During the MECT treatment, electrodes are placed at the right temporal, with propofol 2mg/kg to Induce anesthesia. The right temporal and etomidate Etomidate During the MECT treatment, electrodes are placed at the right temporal, with etomidate 0.3mg/kg to Induce anesthesia. Bilateral frontal and propofol Bilateral frontal MECT During the MECT treatment, electrodes are placed at bilateral frontal, with propofol 2mg/kg to Induce anesthesia. Bilateral frontal and etomidate Etomidate During the MECT treatment, electrodes are placed at bilateral frontal, with etomidate 0.3mg/kg to Induce anesthesia. Bilateral frontal and etomidate Bilateral frontal MECT During the MECT treatment, electrodes are placed at bilateral frontal, with etomidate 0.3mg/kg to Induce anesthesia. Standard-therapy Group Etomidate During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia. Standard-therapy Group Bilateral temporal MECT During the MECT treatment, electrodes are placed at bilateral temporal, with etomidate 0.3mg/kg to Induce anesthesia. Bilateral temporal and propofol Propofol During the MECT treatment, electrodes are placed at bilateral temporal, with propofol 2mg/kg to Induce anesthesia. Bilateral frontal and propofol Propofol During the MECT treatment, electrodes are placed at bilateral frontal, with propofol 2mg/kg to Induce anesthesia.
- Primary Outcome Measures
Name Time Method 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 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 Outcome Measures
Name Time Method Young Manic Rating Scale(MMSE) as a Measure for Evaluation of Mania State 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 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 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 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
Trial Locations
- Locations (1)
Shanghai Mental Health Center
🇨🇳Shanghai, China