DepressionPhase 1/2MSTvsESTNCT01869374
Study Comparing Magnetic Seizure Therapy (MST) to Electroconvulsive Therapy (ECT) for Depression in Older Adults
A Phase 1/2 study testing MagVenture MagPro MST and RUL ECT in people with Depression and Major Depressive Episode, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
To evaluate the feasibility, tolerability and efficacy of Magnetic Seizure Therapy (MST) in elderly patients with a major depressive episode, who are randomly assigned to receive an acute course of MST or ECT. The investigators hypothesize: 1. MST and ECT will have similar antidepressant efficacy 2. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Depression, Major Depressive Episode, Bipolar Disorder
- What is being tested?
- MagVenture MagPro MST and RUL ECT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Aug 2020
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55-90
- Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder
- Willing and capable to provide informed consent
- Convulsive therapy clinically indicated
- Hamilton Rating Scale for Depression (HRSD24)≥ 20
- Mini Mental State Exam (MMSE) ≥ 24
- For outpatients: responsible adult living with the patient
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)
- 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, or vagus nerve stimulator implanted)
- History of head trauma with loss of consciousness for greater than 5 minutes
- History of schizophrenia, schizoaffective disorder, or rapid cycling bipolar disorder
- History of substance abuse or dependence in past 3 months
Show all 9Show fewer
- 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
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
Official title: Improving Outcomes in Geriatric Depression: Magnetic Seizure Therapy
To evaluate the feasibility, tolerability and efficacy of Magnetic Seizure Therapy (MST) in elderly patients with a major depressive episode, who are randomly assigned to receive an acute course of MST or ECT.
The investigators hypothesize:
- MST and ECT will have similar antidepressant efficacy
- MST will have less post-treatment amnesia than ECT as reflected in a 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 older adults 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 rely on a therapeutic seizure, but they do so in different ways. In ECT, an electrical stimulator is used to pass electrical current between two electrodes placed on the surface of person's head, which causes some electricity to go through the brain and cause a seizure. In MST, a magnetic stimulator is used to create a magnetic field in a targeted area of the brain, which induces a small electrical field in the neurons that causes a seizure. Treatments will be administered three times a week.
In addition to the treatment sessions, this study will involve a number of assessments at different time-points (i.e., baseline prior to treatment, post-treatment, 2 months post-treatment and 6 months post-treatment) that are used to evaluate the person's antidepressant response and the physical and cognitive side effects of treatment.
- Conditions
- Depression, Major Depressive Episode, Bipolar Disorder
- Being tested
- MagVenture MagPro MST, RUL ECT
- Keywords
- Depression, Brain Stimulation, Seizure therapy, Convulsive Therapy
- Medical subject headings
- Depression, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagVenture MagPro MSTDevice
Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week.
RUL ECTBiological
Also called Right Unilateral Electroconvulsive Therapy
RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week.
| Study group | Role | What they receive |
|---|---|---|
| Magnetic Seizure Therapy (MST) | Experimental | MagVenture MagPro MST device Receives: Device: MagVenture MagPro MST |
| RUL ECT | Active comparator | Right Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus Receives: Biological: RUL ECT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Rating Scale for Depression, 24-Item (HRSD-24)
The unabbreviated scale title is "Hamilton Rating Scale for Depression." As its title suggests, this is a clinical measure of major depressive disorder.
The minimum score a participant could receive on this measure is 0. The maximum score that a participant could receive is 75. Please see a table written below that associates HRSD-24 values with clinical outcome:
0-7 = no depression 8-16 = mild depression 17-23 = moderate depression 24 and up = severe depression
Calculation details: Outcome data corresponds to baseline HRSD-24 score subtracted from post-tx HRSD-24 score. The larger difference, therefore, corresponds to the more effective treatment for this study.
Measured: baseline (pre-treatment) and post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startAug 2012
- Primary completionJul 2017
- Study completionAug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Electroconvulsive Therapy / Magnetic Seizure Therapy
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stefan Rowny, New York State Psychiatric Institute
- Investigators
- Stefan B Rowny, MD, MFA, Principal investigator, NYSPI/Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869374
- Sponsor's protocol ID
- 6427
- Acronym
- MSTvsEST
- Status last verified
- Aug 2020
- First submitted
- 22 May 2013
- Last updated
- 3 Sep 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Rowny, S., & Lisanby, S. H. (2009). Other Brain Stimulation Methods. In B. J. Sadock, V.A. Sadock & P. Ruiz (Eds.) . Kaplan and Sadock's Comprehensive Textbook of Psychiatry (9th ed.) (Pp. 3301-3314). Lippincott Williams & Wilkins. Philadelphia:PA.
Rowny SB, Benzl K, Lisanby SH. Translational development strategy for magnetic seizure therapy. Exp Neurol. 2009 Sep;219(1):27-35. doi: 10.1016/j.expneurol.2009.03.029. Epub 2009 Apr 5.
PubMed 19348798McClintock SM, DeWind NK, Husain MM, Rowny SB, Spellman TJ, Terrace H, Lisanby SH. Disruption of component processes of spatial working memory by electroconvulsive shock but not magnetic seizure therapy. Int J Neuropsychopharmacol. 2013 Feb;16(1):177-87. doi: 10.1017/S1461145711001866. Epub 2012 Jan 5.
PubMed 22217479Rowny SB, Cycowicz YM, McClintock SM, Truesdale MD, Luber B, Lisanby SH. Differential heart rate response to magnetic seizure therapy (MST) relative to electroconvulsive therapy: a nonhuman primate model. Neuroimage. 2009 Sep;47(3):1086-91. doi: 10.1016/j.neuroimage.2009.05.070. Epub 2009 Jun 2.
PubMed 19497373Rowny, S., & Lisanby, S. H. (2008). Brain Stimulation in Psychiatry. In A. Tasman, J. Kay, J. A. Lieberman, M. B. First & M. Maj (Eds.), Psychiatry (3rd ed.) (pp.2354-2371). Chichester, UK: John Wiley & Sons. DOI: 10.1002/9780470515167.ch109
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 3 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Outcomes in Geriatric Depression: Magnetic Seizure Therapy
- ClinicalTrials.gov ID
- NCT01869374
- Acronym / sponsor ID
- MSTvsEST / 6427
- Conditions
- Depression, Major Depressive Episode, Bipolar Disorder
- Keywords
- Depression, Brain Stimulation, Seizure therapy, Convulsive Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 5 Jun 2013 (estimated)
- Results
- Posted 19 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the feasibility, tolerability and efficacy of Magnetic Seizure Therapy (MST) in elderly patients with a major depressive episode, who are randomly assigned to receive an acute course of MST or ECT.
The investigators hypothesize:
- MST and ECT will have similar antidepressant efficacy
- MST will have less post-treatment amnesia than ECT as reflected in a 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 older adults 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 rely on a therapeutic seizure, but they do so in different ways. In ECT, an electrical stimulator is used to pass electrical current between two electrodes placed on the surface of person's head, which causes some electricity to go through the brain and cause a seizure. In MST, a magnetic stimulator is used to create a magnetic field in a targeted area of the brain, which induces a small electrical field in the neurons that causes a seizure. Treatments will be administered three times a week.
In addition to the treatment sessions, this study will involve a number of assessments at different time-points (i.e., baseline prior to treatment, post-treatment, 2 months post-treatment and 6 months post-treatment) 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
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Electroconvulsive Therapy / Magnetic Seizure Therapy
| Arm | Type | Receives |
|---|---|---|
| Magnetic Seizure Therapy (MST) | Experimental | Device: MagVenture MagPro MSTMagVenture MagPro MST device |
| RUL ECT | Active comparator | Biological: RUL ECTRight Unilateral ECT with the Somatics Thymatron device using Ultrabrief stimulus |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 55-90
- Clinical diagnosis of major depressive episode, in the context of unipolar or bipolar disorder
- Willing and capable to provide informed consent
- Convulsive therapy clinically indicated
- Hamilton Rating Scale for Depression (HRSD24)≥ 20
Key exclusion criteria (9 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)
- 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, or vagus nerve stimulator implanted)
- History of head trauma with loss of consciousness for greater than 5 minutes
- History of schizophrenia, schizoaffective disorder, or rapid cycling bipolar disorder
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 |
|---|---|---|
| MagVenture MagPro MSTBrain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week. | Device | Magnetic Seizure Therapy (MST) |
| RUL ECTAlso: Right Unilateral Electroconvulsive TherapyRUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week. | Biological | RUL ECT |
Primary outcome
Hamilton Rating Scale for Depression, 24-Item (HRSD-24)
Time frame: baseline (pre-treatment) and post-treatment
The unabbreviated scale title is "Hamilton Rating Scale for Depression." As its title suggests, this is a clinical measure of major depressive disorder. The minimum score a participant could receive on this measure is 0. The maximum score that a participant could receive is 75. Please see a table written below that associates HRSD-24 values with clinical outcome: 0-7 = no depression 8-16 = mild depression 17-23 = moderate depression 24 and up = severe depression Calculation details: Outcome data corresponds to baseline HRSD-24 score subtracted from post-tx HRSD-24 score. The larger difference, therefore, corresponds to the more effective treatment for this study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BackgroundRowny, S., & Lisanby, S. H. (2009). Other Brain Stimulation Methods. In B. J. Sadock, V.A. Sadock & P. Ruiz (Eds.) . Kaplan and Sadock's Comprehensive Textbook of Psychiatry (9th ed.) (Pp. 3301-3314). Lippincott Williams & Wilkins. Philadelphia:PA.
- Background: PubMed 19348798Rowny SB, Benzl K, Lisanby SH. Translational development strategy for magnetic seizure therapy. Exp Neurol. 2009 Sep;219(1):27-35. doi: 10.1016/j.expneurol.2009.03.029. Epub 2009 Apr 5.
- Background: PubMed 22217479McClintock SM, DeWind NK, Husain MM, Rowny SB, Spellman TJ, Terrace H, Lisanby SH. Disruption of component processes of spatial working memory by electroconvulsive shock but not magnetic seizure therapy. Int J Neuropsychopharmacol. 2013 Feb;16(1):177-87. doi: 10.1017/S1461145711001866. Epub 2012 Jan 5.
- Background: PubMed 19497373Rowny SB, Cycowicz YM, McClintock SM, Truesdale MD, Luber B, Lisanby SH. Differential heart rate response to magnetic seizure therapy (MST) relative to electroconvulsive therapy: a nonhuman primate model. Neuroimage. 2009 Sep;47(3):1086-91. doi: 10.1016/j.neuroimage.2009.05.070. Epub 2009 Jun 2.
- BackgroundRowny, S., & Lisanby, S. H. (2008). Brain Stimulation in Psychiatry. In A. Tasman, J. Kay, J. A. Lieberman, M. B. First & M. Maj (Eds.), Psychiatry (3rd ed.) (pp.2354-2371). Chichester, UK: John Wiley & Sons. DOI: 10.1002/9780470515167.ch109
- 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.
- Individual participant dataSharing planned: No
Related trials for Depression
Not yet recruitingObservational study
Validation of Wearable Core Body Temperature-Based Circadian Rhythm Digital Biomarkers
Mood Disorders, Major Depressive Diorder
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
RecruitingPhase 3
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
Major Depressive Disorder
Recruiting
Anticipated Patient and Caregiver Burden
Amyotrophic Lateral Sclerosis
Recruiting
A Study of Brief Behavioral Activation for the Treatment of Depression in Older Adult Cancer Survivors
Survivorship
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.
Stefan B Rowny, MD, MFA principal investigator
NYSPI/Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MagVenture MagPro MST and RUL ECT in people with Depression and Major Depressive Episode, run by New York State Psychiatric Institute at 1 site 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 7 inclusion and 9 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 3 Sep 2020. 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 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 19 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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, 24-Item (HRSD-24) (time frame: baseline (pre-treatment) and post-treatment). 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 NCT01869374, which also lists 6 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 3 Sep 2020.