Major Depressive DisorderPhase 2MST-2NCT00973934
Magnetic Seizure Therapy (MST) for the Treatment of Major Depression
A Phase 2 study testing Magstim Theta and Thymatron System IV in people with Major Depressive Disorder, run by Sarah Lisanby at 2 sites in United States.
Trial summary
This two-center, between-subject, randomized, double-masked study (n=20) will provide the first evidence for the antidepressant efficacy of Magnetic Seizure Therapy (MST) and contrast the therapeutic properties and side effects of two forms of MST in patients in a major depressive episode (MDE). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Magstim Theta and Thymatron System IV
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2002to Dec 2009
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder
- Age 18-75
- Use of effective method of birth control for women of child-bearing capacity
- Willing and capable of providing informed consent
- Convulsive therapy clinically indicated
- Hamilton Rating Scale for Depression (HRSD) ≥18 (24 item)
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, or structural brain lesion
- Presence of devices that may be affected by rTMS (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 11Show 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
Duke Universtiy Medical Center
Durham, North Carolina, 27710
About this study
This two-center, between-subject, randomized, double-masked study (n=20) will provide the first evidence for the antidepressant efficacy of Magnetic Seizure Therapy (MST) and contrast the therapeutic properties and side effects of two forms of MST in patients in a major depressive episode (MDE).
- Conditions
- Major Depressive Disorder
- Being tested
- Magstim Theta, Thymatron System IV
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magstim ThetaDevice
Thymatron System IVDevice
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Seizure therapy (MST) | Experimental | Eligible patients will be randomized to receive either a course of thrice weekly MST using either a focal or non focal stimulating coil. Receives: Device: Magstim Theta |
| Right Unilateral Electroconvulsive Therapy | Active comparator | Not described Receives: Device: Thymatron System IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression (HRSD), 24 item
Measured: A blinded rater will administer the test at Baseline, every Tuesday and Thursday during the treatment course and at the end of the MST course
Secondary outcomes (2)
Beck Depression Inventory
Measured: A blinded rater will administer the test at Baseline, every Tuesday and Thursady during the treatment course and at the end of the MST course
Neuropsychological testings to assess the acute, short term, long term memory effects of the treatments
Measured: A blinded rater will administer various neurospychologiocal tests at various timepoints (baseline, within 3 days following the MST course and at 2 months following the MST course. Treatment Effect Battery (TEB) will be administered at each MST session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startApr 2002
- Primary completionJan 2006
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sarah Lisanby
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas, Stanley Medical Research Institute
- Responsible party
- Sponsor-investigator, Sarah Lisanby, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973934
- Sponsor's protocol ID
- 4371
- Other IDs
- 01-069
- Acronym
- MST-2
- Status last verified
- Jun 2014
- First submitted
- 4 Sep 2009
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jiang 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 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Seizure Therapy (MST) for the Treatment of Major Depression
- ClinicalTrials.gov ID
- NCT00973934
- Acronym / sponsor ID
- MST-2 / 4371
- Conditions
- Major Depressive Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Sarah LisanbyUniversity, hospital or other
- Collaborators
- University of Texas, Stanley Medical Research Institute
- Study start
- Apr 2002
- Primary completion
- Jan 2006 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 9 Sep 2009 (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 two-center, between-subject, randomized, double-masked study (n=20) will provide the first evidence for the antidepressant efficacy of Magnetic Seizure Therapy (MST) and contrast the therapeutic properties and side effects of two forms of MST in patients in a major depressive episode (MDE).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Magnetic Seizure therapy (MST) | Experimental | Device: Magstim ThetaEligible patients will be randomized to receive either a course of thrice weekly MST using either a focal or non focal stimulating coil. |
| Right Unilateral Electroconvulsive Therapy | Active comparator | Device: Thymatron System IV |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder
- Age 18-75
- Use of effective method of birth control for women of child-bearing capacity
- Willing and capable of providing informed consent
- Convulsive therapy clinically indicated
Key exclusion criteria (11 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, or structural brain lesion
- Presence of devices that may be affected by rTMS (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 |
|---|---|---|
| Magstim Theta | Device | Magnetic Seizure therapy (MST) |
| Thymatron System IV | Device | Right Unilateral Electroconvulsive Therapy |
Primary outcome
Hamilton Rating Scale for Depression (HRSD), 24 item
Time frame: A blinded rater will administer the test at Baseline, every Tuesday and Thursday during the treatment course and at the end of the MST course
2 secondary outcomes
Beck Depression Inventory
Time frame: A blinded rater will administer the test at Baseline, every Tuesday and Thursady during the treatment course and at the end of the MST course
Neuropsychological testings to assess the acute, short term, long term memory effects of the treatments
Time frame: A blinded rater will administer various neurospychologiocal tests at various timepoints (baseline, within 3 days following the MST course and at 2 months following the MST course. Treatment Effect Battery (TEB) will be administered at each MST session.
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 10 Jun 2014.
- 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Magstim Theta and Thymatron System IV in people with Major Depressive Disorder, 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 11 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 10 Jun 2014. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Hamilton Rating Scale for Depression (HRSD), 24 item (time frame: A blinded rater will administer the test at Baseline, every Tuesday and Thursday during the treatment course and at the end of the MST 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 NCT00973934, which also lists 1 linked publication.
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 10 Jun 2014.