Predict MDE Outcomes After MST

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

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).

Study Overview

• Status: Completed
• Conditions: Major Depressive Episode
• Intervention / Treatment: Device: Magpro X100 + Option; Device: ThymatronSystem Ⅳ Electroconvulsive System

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jianhua Sheng, PHD; Phone Number: 86-21-34773759; Email: shengjianhua66@163.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200030
      • Shanghai Mental Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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	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

Collaborators and Investigators

• Sponsor: Shanghai Mental Health Center
• Investigators: Principal Investigator: Jianhua Sheng, PhD, Shanghai Mental Health Center

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2020
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): May 10, 2023

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: February 12, 2019
• First Posted (Actual): February 15, 2019

Study Record Updates

• Last Update Posted (Actual): October 31, 2023
• Last Update Submitted That Met QC Criteria: October 29, 2023
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 201840269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No