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Predict MDE Outcomes After MST

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ClinicalTrials.gov Identifier: NCT03841019
Recruitment Status : Recruiting
First Posted : February 15, 2019
Last Update Posted : February 24, 2022
Sponsor:
Information provided by (Responsible Party):
Shanghai Mental Health Center

Study Description
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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).

Condition or disease Intervention/treatment Phase
Major Depressive Episode Device: Magpro X100 + Option Device: ThymatronSystem Ⅳ Electroconvulsive System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Research on the Prediction of Clinical Response to Magnetic Seizure Therapy for Patients With Major Depression Episode
Actual Study Start Date : July 20, 2020
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Arms and Interventions
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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)


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03841019


Contacts
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Contact: Jianhua Sheng, PHD 86-21-34773759 shengjianhua66@163.com

Locations
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China, Shanghai
Shanghai Mental Health Center Recruiting
Shanghai, Shanghai, China, 200030
Contact: Jianhua Sheng, PHD         
Sponsors and Collaborators
Shanghai Mental Health Center
Investigators
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Principal Investigator: Jianhua Sheng, PHD Shanghai Mental Health Center
More Information
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Responsible Party: Shanghai Mental Health Center
ClinicalTrials.gov Identifier: NCT03841019    
Other Study ID Numbers: 201840269
First Posted: February 15, 2019    Key Record Dates
Last Update Posted: February 24, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No