Major Depressive EpisodeNCT03841019
Predict MDE Outcomes After MST
A study testing Magpro X100 + Option and ThymatronSystem Ⅳ Electroconvulsive System in people with Major Depressive Episode, run by Shanghai Mental Health Center at 1 site in China.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Episode
- What is being tested?
- Magpro X100 + Option and ThymatronSystem Ⅳ Electroconvulsive System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2020to 10 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
About this study
Official title: 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).
Read the 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.
- Conditions
- Major Depressive Episode
- Being tested
- Magpro X100 + Option, ThymatronSystem Ⅳ Electroconvulsive System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magpro X100 + OptionDevice
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 SystemDevice
In addition to treatment as usual (TAU), participants were supposed to receive twelve sessions of ECT in four weeks (three sessions per week)
| Study group | Role | What they receive |
|---|---|---|
| magnetic seizure therapy | Experimental | 12 treatment sessions of MST, three times per week. Receives: Device: Magpro X100 + Option |
| electroconvulsive therapy | Active comparator | 12 treatment sessions of ECT, three times per week. Receives: Device: ThymatronSystem Ⅳ Electroconvulsive System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and 4-week follow-up
Secondary outcomes (4)
changes in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Measured: At baseline and 4-week follow-up
changes in the spectral power of the electroencephalogram (EEG) in square microvolt during resting state
Measured: 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
Measured: At baseline and 4-week follow-up
changes in the spectral power of the electroencephalogram (EEG) in square microvolt during the facial recognition task.
Measured: At baseline and 4-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start20 Jul 2020
- Primary completion15 Feb 2023
- Study completion10 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive EpisodeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jianhua Sheng, PHD, Principal investigator, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841019
- Sponsor's protocol ID
- 201840269
- Status last verified
- Sep 2022
- First submitted
- 17 Jan 2019
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Prediction of Clinical Response to Magnetic Seizure Therapy for Patients With Major Depression Episode
- ClinicalTrials.gov ID
- NCT03841019
- Acronym / sponsor ID
- 201840269
- Conditions
- Major Depressive Episode
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 15 Feb 2023 (actual)
- Study completion
- 10 May 2023 (actual)
- First posted
- 15 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| magnetic seizure therapy | Experimental | Device: Magpro X100 + Option12 treatment sessions of MST, three times per week. |
| electroconvulsive therapy | Active comparator | Device: ThymatronSystem Ⅳ Electroconvulsive System12 treatment sessions of ECT, three times per week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magpro X100 + OptionIn addition to treatment as usual (TAU), participants were supposed to receive twelve sessions of MST in four weeks (three sessions per week) | Device | magnetic seizure therapy |
| ThymatronSystem Ⅳ Electroconvulsive SystemIn addition to treatment as usual (TAU), participants were supposed to receive twelve sessions of ECT in four weeks (three sessions per week) | Device | electroconvulsive therapy |
Primary outcome
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.
4 secondary outcomes
changes in the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: At baseline and 4-week follow-up
changes in the spectral power of the electroencephalogram (EEG) in square microvolt during resting state
Time frame: 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
Time frame: At baseline and 4-week follow-up
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianhua Sheng, PHD principal investigator
Shanghai Mental Health Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magpro X100 + Option and ThymatronSystem Ⅳ Electroconvulsive System in people with Major Depressive Episode, run by Shanghai Mental Health Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in the 17-item Hamilton Depression Rating Scale (HAMD-17) (time frame: At baseline and 4-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.