Predict MDE Outcomes After MST

NCT03841019 | Completed DMC

• 1 other identifier: 201840269
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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).

Conditions

Major Depressive Episode

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

magnetic seizure therapy

EXPERIMENTAL

12 treatment sessions of MST, three times per week.

Device: Magpro X100 + Option

electroconvulsive therapy

ACTIVE COMPARATOR

12 treatment sessions of ECT, three times per week.

Device: ThymatronSystem Ⅳ Electroconvulsive System

Interventions

Magpro X100 + Option DEVICE

In addition to treatment as usual (TAU), participants were supposed to receive twelve sessions of MST in four weeks (three sessions per week)

magnetic seizure therapy

ThymatronSystem Ⅳ Electroconvulsive System DEVICE

In addition to treatment as usual (TAU), participants were supposed to receive twelve sessions of ECT in four weeks (three sessions per week)

electroconvulsive therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Mental Health Center: lead

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Study Officials

• Jianhua Sheng, PHD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2019
• First Posted: February 15, 2019
• Study Start: July 20, 2020
• Primary Completion: February 15, 2023
• Study Completion: May 10, 2023
• Last Updated: October 31, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)