DepressionPhase 3NCT00488748
Magnetic Seizure Therapy (MST) for Severe Mood Disorder
A Phase 3 study testing Thymatron and Magstim Theta in people with Depression, run by Sarah Lisanby at 2 sites in United States.
Trial summary
This study will compare the clinical efficacy and side effects of Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in patients currently experiencing a major depressive episode in the context of either unipolar or bipolar depression. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Depression
- What is being tested?
- Thymatron and Magstim Theta
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2007to Aug 2012
- Phase
- Phase 3
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-90
- Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder
- Use of effective method of birth control for women of child-bearing capacity
- Willing and capable to provide informed consent
- Convulsive therapy clinically indicated
- Hamilton Rating Scale for Depression (HRSD24) ≥ 20
Who cannot join
- Current unstable or serious medical condition, or any comorbid medical condition that substantially increases the risks of ECT (such as acute myocardial infarction, space occupying brain lesion or other cause of increased intracranial pressure, unstable aneurysm or vascular malformation, poorly controlled diabetes mellitus, carcinoma, renal failure, hepatic failure)
- Pregnancy
- History of neurological disorder, epilepsy, stroke, brain surgery, metal in the head, history of known structural brain lesion
- Presence of devices that may be affected by MST (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- Breast-feeding
- History of head trauma with loss of consciousness for greater than 5 minutes
Show all 12Show fewer
- History of schizophrenia, schizoaffective disorder, or rapid cycling bipolar disorder
- Vagus nerve stimulator implanted
- History of substance abuse or dependence in past 3 months
- Failure to respond to an adequate course of ECT in the current depressive episode
- History of ECT in the past 6 months and/or failure to respond to an adequate trial of ECT lifetime
- Presence of intracardiac lines
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke University
Durham, North Carolina, 27710
About this study
Official title: Magnetic Seizure Therapy (MST) for the Treatment of Severe Mood Disorder
This study will compare the clinical efficacy and side effects of Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in patients currently experiencing a major depressive episode in the context of either unipolar or bipolar depression. The investigators will conduct a number of clinical and neuropsychological tests to assess clinical and cognitive response to treatment. The investigators hypothesize that:
- MST and ECT will have similar antidepressant efficacy.
- MST will have less post-treatment amnesia than ECT as reflected in primary measures of anterograde and retrograde amnesia following the acute treatment phase.
- At follow up, MST will show a lesser degree of persisting deficit in measures of retrograde amnesia than ECT.
Read the detailed description
The purpose of this study is to compare the clinical efficacy and side effects of Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in patients currently experiencing a major depressive episode in the context of either unipolar or bipolar depression. ECT is known to be highly effective in treating depression, but it can have some adverse cognitive side effects. MST is a new form of convulsive therapy that is being developed as a means of improving the side effect profile of ECT so that more patients may benefit without suffering significant detrimental effects on cognition.
Both ECT and MST cause a seizure, but they do so in different ways. In ECT, an electrical stimulator is used to pass an electrical current between two electrodes placed on the person's head, which causes some electricity to go through the brain and cause a seizure. In MST, a magnetic stimulator is used to pass a magnetic field to the brain, which then creates a small electrical field in the brain that causes a seizure.
In addition to the treatment sessions, this study will involve a number of assessments at different timepoints that are used to evaluate the person's antidepressant response and the physical and cognitive side effects of treatment.
- Conditions
- Depression
- Being tested
- Thymatron, Magstim Theta
- Keywords
- MST, Magnetic Seizure Therapy, ECT, Electroconvulsive Therapy, Depression, Magnetic
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThymatronDevice
Also called Thymatron, Electroconvulsive Therapy (ECT)
Right unilateral placement, 6x seizure threshold, 3 times per week until clinically appropriate to stop (approximately 2-6 weeks)
Magstim ThetaDevice
Also called Magstim Theta, Magnetic Seizure Therapy (MST)
100% power, vertex placement, 3 times per week, until clinically appropriate to stop (approximately 2-6 weeks)
| Study group | Role | What they receive |
|---|---|---|
| MST | Experimental | Magnetic Seizure Therapy (MST) Receives: Device: Magstim Theta |
| ECT | Active comparator | Electroconvulsive Therapy (ECT) Receives: Device: Thymatron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement (Hamilton Rating Scale for Depression)
Measured: After each treatment and at follow-ups up to 6 months after the treatment course
Secondary outcomes (1)
Clinical improvement (Inventory of Depressive Symptomatology - Clinician-Rated)
Measured: Before and after treatment course, and at follow-ups up to 6 months after the treatment course
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Lisanby
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, University of Texas Southwestern Medical Center, Stanley Medical Research Institute
- Responsible party
- Sponsor-investigator, Sarah Lisanby, Duke University
- Investigators
- Sarah H. Lisanby, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488748
- Sponsor's protocol ID
- Pro00026868
- Other IDs
- Stanley Grant #05T656
- Status last verified
- Jan 2015
- First submitted
- 18 Jun 2007
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Lisanby SH, Luber B, Schlaepfer TE, Sackeim HA. Safety and feasibility of magnetic seizure therapy (MST) in major depression: randomized within-subject comparison with electroconvulsive therapy. Neuropsychopharmacology. 2003 Oct;28(10):1852-65. doi: 10.1038/sj.npp.1300229.
PubMed 12865903Kosel M, Frick C, Lisanby SH, Fisch HU, Schlaepfer TE. Magnetic seizure therapy improves mood in refractory major depression. Neuropsychopharmacology. 2003 Nov;28(11):2045-8. doi: 10.1038/sj.npp.1300293.
PubMed 12942146Deng ZD, Luber B, McClintock SM, Weiner RD, Husain MM, Lisanby SH. Clinical Outcomes of Magnetic Seizure Therapy vs Electroconvulsive Therapy for Major Depressive Episode: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Mar 1;81(3):240-249. doi: 10.1001/jamapsychiatry.2023.4599.
PubMed 38055283Jiang J, Zhang C, Li C, Chen Z, Cao X, Wang H, Li W, Wang J. Magnetic seizure therapy for treatment-resistant depression. Cochrane Database Syst Rev. 2021 Jun 16;6(6):CD013528. doi: 10.1002/14651858.CD013528.pub2.
PubMed 34131914
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Seizure Therapy (MST) for the Treatment of Severe Mood Disorder
- ClinicalTrials.gov ID
- NCT00488748
- Acronym / sponsor ID
- Pro00026868
- Conditions
- Depression
- Keywords
- MST, Magnetic Seizure Therapy, ECT, Electroconvulsive Therapy, Depression, Magnetic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Sarah LisanbyUniversity, hospital or other
- Collaborators
- Duke University, University of Texas Southwestern Medical Center, Stanley Medical Research Institute
- Study start
- Jun 2007
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 20 Jun 2007 (estimated)
- 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 study will compare the clinical efficacy and side effects of Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in patients currently experiencing a major depressive episode in the context of either unipolar or bipolar depression. The investigators will conduct a number of clinical and neuropsychological tests to assess clinical and cognitive response to treatment. The investigators hypothesize that:
- MST and ECT will have similar antidepressant efficacy.
- MST will have less post-treatment amnesia than ECT as reflected in primary measures of anterograde and retrograde amnesia following the acute treatment phase.
- At follow up, MST will show a lesser degree of persisting deficit in measures of retrograde amnesia than ECT.
Detailed description
The purpose of this study is to compare the clinical efficacy and side effects of Magnetic Seizure Therapy (MST) and Electroconvulsive Therapy (ECT) in patients currently experiencing a major depressive episode in the context of either unipolar or bipolar depression. ECT is known to be highly effective in treating depression, but it can have some adverse cognitive side effects. MST is a new form of convulsive therapy that is being developed as a means of improving the side effect profile of ECT so that more patients may benefit without suffering significant detrimental effects on cognition.
Both ECT and MST cause a seizure, but they do so in different ways. In ECT, an electrical stimulator is used to pass an electrical current between two electrodes placed on the person's head, which causes some electricity to go through the brain and cause a seizure. In MST, a magnetic stimulator is used to pass a magnetic field to the brain, which then creates a small electrical field in the brain that causes a seizure.
In addition to the treatment sessions, this study will involve a number of assessments at different timepoints that are used to evaluate the person's antidepressant response and the physical and cognitive side effects of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MST | Experimental | Device: Magstim ThetaMagnetic Seizure Therapy (MST) |
| ECT | Active comparator | Device: ThymatronElectroconvulsive Therapy (ECT) |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18-90
- Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder
- Use of effective method of birth control for women of child-bearing capacity
- Willing and capable to provide informed consent
- Convulsive therapy clinically indicated
Key exclusion criteria (12 listed)
- Current unstable or serious medical condition, or any comorbid medical condition that substantially increases the risks of ECT (such as acute myocardial infarction, space occupying brain lesion or other cause of increased intracranial pressure, unstable aneurysm or vascular malformation, poorly controlled diabetes mellitus, carcinoma, renal failure, hepatic failure)
- Pregnancy
- History of neurological disorder, epilepsy, stroke, brain surgery, metal in the head, history of known structural brain lesion
- Presence of devices that may be affected by MST (pacemaker, medication pump, cochlear implant, implanted brain stimulator)
- Breast-feeding
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 |
|---|---|---|
| ThymatronAlso: Thymatron, Electroconvulsive Therapy (ECT)Right unilateral placement, 6x seizure threshold, 3 times per week until clinically appropriate to stop (approximately 2-6 weeks) | Device | ECT |
| Magstim ThetaAlso: Magstim Theta, Magnetic Seizure Therapy (MST)100% power, vertex placement, 3 times per week, until clinically appropriate to stop (approximately 2-6 weeks) | Device | MST |
Primary outcome
Clinical improvement (Hamilton Rating Scale for Depression)
Time frame: After each treatment and at follow-ups up to 6 months after the treatment course
1 secondary outcome
Clinical improvement (Inventory of Depressive Symptomatology - Clinician-Rated)
Time frame: Before and after treatment course, and at follow-ups up to 6 months after the treatment course
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 28 Jan 2015.
- Background: PubMed 12865903Lisanby SH, Luber B, Schlaepfer TE, Sackeim HA. Safety and feasibility of magnetic seizure therapy (MST) in major depression: randomized within-subject comparison with electroconvulsive therapy. Neuropsychopharmacology. 2003 Oct;28(10):1852-65. doi: 10.1038/sj.npp.1300229.
- Background: PubMed 12942146Kosel M, Frick C, Lisanby SH, Fisch HU, Schlaepfer TE. Magnetic seizure therapy improves mood in refractory major depression. Neuropsychopharmacology. 2003 Nov;28(11):2045-8. doi: 10.1038/sj.npp.1300293.
- Derived from this study: PubMed 38055283Deng ZD, Luber B, McClintock SM, Weiner RD, Husain MM, Lisanby SH. Clinical Outcomes of Magnetic Seizure Therapy vs Electroconvulsive Therapy for Major Depressive Episode: A Randomized Clinical Trial. JAMA Psychiatry. 2024 Mar 1;81(3):240-249. doi: 10.1001/jamapsychiatry.2023.4599.
- Derived from this study: PubMed 34131914Jiang J, Zhang C, Li C, Chen Z, Cao X, Wang H, Li W, Wang J. Magnetic seizure therapy for treatment-resistant depression. Cochrane Database Syst Rev. 2021 Jun 16;6(6):CD013528. doi: 10.1002/14651858.CD013528.pub2.
- National Institute of Mental Health - DepressionLink provided by the sponsor.
- Summary of MST study on Duke Health websiteLink provided by the sponsor.
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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.
Sarah H. Lisanby, MD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Thymatron and Magstim Theta in people with Depression, run by Sarah Lisanby at 2 sites in United States.
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 6 inclusion and 12 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 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Clinical improvement (Hamilton Rating Scale for Depression) (time frame: After each treatment and at follow-ups up to 6 months after the treatment course). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00488748, which also lists 4 linked publications.
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 28 Jan 2015.