Predict MDE Outcomes After MST

Not Applicable

Completed

• Conditions: Major Depressive Episode
• Interventions: Device: ThymatronSystem Ⅳ Electroconvulsive System; Device: Magpro X100 + Option

• Registration Number: NCT03841019
• Lead Sponsor: Shanghai Mental Health Center

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.

Study Timeline

• Study First Submitted: 2019-01-17
• Study First Submitted QC: 2019-02-12
• Study First Posted: 2019-02-15
• Study Start: 2020-07-20
• Status Verified: 2022-09
• Primary Completion: 2023-02-15
• Study Completion: 2023-05-10
• Last Update Submitted: 2023-10-29
• Last Update Posted: 2023-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. DSM-5 diagnosis of major depressive episode;
2. convulsive therapy clinically indicated, such as severe psychomotor excitement or retardation, attempts of suicide, being highly aggressive, pharmacotherapy intolerance, and ineffectiveness of antipsychotics;
3. the HAMD-17 ≥ 24;
4. informed consent in written form.

Exclusion Criteria

1. primary diagnosis of other mental disorders;
2. severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and immune deficiency;
3. present with a laboratory abnormality that could impact on efficacy of treatments or safety of participants;
4. failure to respond to an adequate trial of ECT lifetime;
5. are pregnant or intend to get pregnant during the study;
6. Unremovable metal implants.
7. other conditions that investigators consider to be inappropriate to participate in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
electroconvulsive therapy	ThymatronSystem Ⅳ Electroconvulsive System	12 treatment sessions of ECT, three times per week.
magnetic seizure therapy	Magpro X100 + Option	12 treatment sessions of MST, three times per week.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Shanghai Mental Health Center; 🇨🇳 Shanghai, Shanghai, China