Predict MDE Outcomes After MST

Study Overview
=================
Brief Summary
-----------------
This trial attempts to explore the treatment outcome of magnetic seizure therapy (MST) for major depressive episode. Half of the participants will receive MST, while the other half will receive electroconvulsive therapy (ECT).

Detailed Description
-----------------
Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive therapy (ECT). Widespread stimulation of cortical and subcortical regions is inevitable for ECT since the substantial impedance of the scalp and skull shuts most of the electrical stimulus away from the brain. Nevertheless, magnetic pulses are capable to focus the stimulus to a specific area of the brain because they can pass the scalp and skull without resistance. In Addition, electric current will penetrate into deeper structures, while magnetic stimulus are only capable to reach a depth of a few centimeters. As a consequence, MST are able to generate focus stimuli on superficial regions of the cortex while ECT can't, which may give MST the capability to produce comparable therapeutic benefits with the absence of apparent cognitive side effects.

Official Title
-----------------
Research on the Prediction of Clinical Response to Magnetic Seizure Therapy for Patients With Major Depression Episode

Conditions
-----------------
Major Depressive Episode

Intervention / Treatment
-----------------
* Device: Magpro X100 + Option
* Device: ThymatronSystem Ⅳ Electroconvulsive System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: DSM-5 diagnosis of major depressive episode; convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics; the HAMD-17 ≥ 24; informed consent in written form. Exclusion Criteria: primary diagnosis of other mental disorders; severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and immune deficiency; present with a laboratory abnormality that could impact on efficacy of treatments or safety of participants; failure to respond to an adequate trial of ECT lifetime; are pregnant or intend to get pregnant during the study; Unremovable metal implants. other conditions that investigators consider to be inappropriate to participate in this trial.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: magnetic seizure therapy<br>12 treatment sessions of MST, three times per week. | Device: Magpro X100 + Option<br>* In addition to treatment as usual (TAU), participants were supposed to receive twelve sessions of MST in four weeks (three sessions per week)<br>|
| Active Comparator: electroconvulsive therapy<br>12 treatment sessions of ECT, three times per week. | Device: ThymatronSystem Ⅳ Electroconvulsive System<br>* In addition to treatment as usual (TAU), participants were supposed to receive twelve sessions of ECT in four weeks (three sessions per week)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the 17-item Hamilton Depression Rating Scale (HAMD-17) | The HAMD-17 score ranges from 0 to 52. A higher score indicates a worse outcome. | At baseline and 4-week follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) |  | At baseline and 4-week follow-up | 
| changes in the spectral power of the electroencephalogram (EEG) in square microvolt during resting state |  | At baseline and 4-week follow-up | 
| changes in the spectral power of the electroencephalogram (EEG) in square microvolt during the auditory mismatch negativity task |  | At baseline and 4-week follow-up | 
| changes in the spectral power of the electroencephalogram (EEG) in square microvolt during the facial recognition task. |  | At baseline and 4-week follow-up |