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Completed

NCT Number: NCT03841019

Predict MDE Outcomes After MST

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).

Completed

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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)

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)

Primary outcomes

  1. changes in the 17-item Hamilton Depression Rating Scale (HAMD-17)

    Time frame: At baseline and 4-week follow-up

    The HAMD-17 score ranges from 0 to 52. A higher score indicates a worse outcome.

Secondary outcomes

  1. changes in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Time frame: At baseline and 4-week follow-up

  2. changes in the spectral power of the electroencephalogram (EEG) in square microvolt during resting state

    Time frame: At baseline and 4-week follow-up

  3. changes in the spectral power of the electroencephalogram (EEG) in square microvolt during the auditory mismatch negativity task

    Time frame: At baseline and 4-week follow-up

  4. changes in the spectral power of the electroencephalogram (EEG) in square microvolt during the facial recognition task.

    Time frame: At baseline and 4-week follow-up

Sponsors and collaborators

Lead sponsor

Shanghai Mental Health Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2019
Registry last updated
Oct 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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