Predict MDE Outcomes After MST

Major Depressive Episode Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03841019
• Other study ID #: 201840269
• Status: Completed
• Phase: N/A
• Start date: July 20, 2020
• Est. completion date: May 10, 2023

Study information

• Verified date: September 2022
• Source: Shanghai Mental Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 10, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Major Depressive Episode

Intervention

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)
• ThymatronSystem ? 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)

Locations

Country	Name	City	State
China	Shanghai Mental Health Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Mental Health Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	changes in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)		At baseline and 4-week follow-up
Secondary	changes in the spectral power of the electroencephalogram (EEG) in square microvolt during resting state		At baseline and 4-week follow-up
Secondary	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
Secondary	changes in the spectral power of the electroencephalogram (EEG) in square microvolt during the facial recognition task.		At baseline and 4-week follow-up