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Bipolar DisorderNCT04080778

Magnetic Seizure Therapy in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD)

A study testing magnetic seizure therapy (MST) and electroconvulsive therapy (ECT) in people with Bipolar Disorder, run by Joao L. DeQuevedo at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to compare the efficacy and side effects magnetic seizure therapy (MST) and electroconvulsive therapy (ECT) in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD). Read more about this study

Who is it for?
Ages 22 to 85 years
Conditions the study is for
Bipolar Disorder
What is being tested?
magnetic seizure therapy (MST) and electroconvulsive therapy (ECT)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
24 Aug 2024to 30 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 22 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The condition under study: Patients who are diagnosed by Bipolar I or II, current episode depressed according to the ICD-10 diagnostic criteria (F31.3, F31.4, F31.5, F31.81) or treatment resistant depression defined below who require a rapid response due to the severity of their psychiatric or medical condition. ICD-10 Diagnostic Criteria for Bipolar Depression is as follows: A disorder characterized by two or more episodes in which the patient's mood and activity levels are significantly disturbed, this disturbance consisting on some occasions of an elevation of mood and increased energy and activity (hypomania or mania) and on others of a lowering of mood and decreased energy and activity (depression). Repeated episodes of hypomania or mania only are classified as bipolar. The patient is currently depressed, as in a depressive episode and has had at least one authenticated hypomanic, manic, or mixed affective episode in the past. Subjects with treatment resistant depression and have severe depression will be enrolled to the study. Severe depression will be defined as Hamilton Depression Severity Rating Scale score above 19 and also treatment resistance is described as a lack of clinically meaningful improvement in depressive symptoms after treatment with at least two different oral antidepressant medications as monotherapy, taken at adequate doses for adequate duration (at least 6 weeks) for their current episode of depression. The previous oral antidepressants could be from the same or different drug classes, which could include SSRIs, SNRIs, tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), or any other oral antidepressants (FDA, 2019). Since its development in 1960 by Dr. Max Hamilton of the University of Leeds, England, Hamilton Depression Severity Rating Scale has been widely used in clinical practice and become a standard in pharmaceutical trials
  • Both males and females any race and ethnic group.
  • Age range between 22-85 years old.
  • Ability to provide informed consent or assent.
  • Ability to adhere to the study procedures.
  • For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional one week after the end of ECT/TMS administration. Of note, ECT is indicated in depression during pregnancy and has been safely used for decades but MST's effects on fetus are still unknown
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  • For males of reproductive potential: use of condoms or other methods to ensure effective contraception with partner.
  • Has sufficient English in completing self-rated scales.
  • Good general health evidenced by obtained medical clearance before the procedures from another provider.
  • On a stable drug regimen of psychotropic medication for at least 6 weeks at the time of entry into the study. Medication changes can be made during patient's study participation but would be limited to the clinical judgment of the PI.

Who cannot join

  • Condition or diagnosis that precludes participation, including: Patients who have an implanted device that is activated or controlled in any way by physiological signals (examples: pacemakers, implantable cardioverter defibrillators [ICD's], vagus nerve stimulators [VNS] and wearable cardioverter-defibrillators [WCD's],ocular implants, deep brain stimulators, implanted medication pumps, intracardiac lines, even when removed; Patients who have conductive, ferromagnetic or other magnetic sensitive metals implanted in their head or within 30 cm of the treatment coil such as stents and bullet fragments). NOTE: Standard amalgam dental fillings are not affected by the magnetic field and are acceptable in patients]; Patients suffering from vascular, traumatic, infectious, or metabolic lesions of the brain, even without a history of seizure, or without anticonvulsant medication; Patient suffering from sleep deprivation or alcoholism; Current or unstably remitted substance use disorder except nicotine or caffeine use disorder. Stable remission is defined as remission for at least 6 months; Pregnant or nursing patients; Patients with a history of epilepsy or unexplained seizures; Subjects with a history of space-occupying intracranial pathology; diseases which render a patient likely to suffer hemorrhage, including subdural hematoma, and aortic aneurysm; degenerative diseases of the central nervous system such as dementia or medical illness affecting brain function; Any anesthesia contraindications including significant cardiac or other medical risk factors; Body Mass Index over 60, as our ECT suite stretchers are not equipped to handle overweight patients; History of severe personality disorder, where, based on the judgment of the investigators, the personality disorder will interfere with the patient's ability to complete the follow-up protocol, e.g. borderline personality disorder; Imminent risk of suicide (based on the judgment of the investigators; e.g. patient has a plan for suicide, patient is not likely to seek medical attention in case of suicide, patient exhibits the presence of current suicidal ideation; Not able to comply with the operational and administrative requirements of participation in the study (based on the judgment of the investigators); Terminal illness associated with expected survival of <12 months; Bipolar Depression with psychotic features (ICD-10 code:F31.5)
  • Known allergic reactions to components of anaesthetic or induction agents including succinylcholine, metohexitol, ketamine, propofol, ketorolac.
  • Participation in another drug, device, or biologics trial within the preceding 30 days
  • Disallowed concomitant medications: antiepileptics and benzodiazepines as they are against seizure therapies, short or mid acting benzodiazepines such as alprazolam, temazepam, midazolam, lorazepam will be allowed but they should be skipped at least 10 hours before the procedures. Medications that are supposed to have weak antiepileptic features such as lamotrigine, topiramate, gabapentin will be reviewed by the PI and either tapered down or discontinued based upon clinical judgment. Lithium will be tapered off before the procedure because of the increased risk of postictal disorientation and delirium.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

    Joao L. De Quevedo, MD,PhD, 713-486-2705, Joao.L.DeQuevedo@uth.tmc.edu

    Ana Ruiz, (713) 741-3951, Ana.C.Ruiz@uth.tmc.edu

    Recruiting

Other trials in United States

About this study

The purpose of this study is to compare the efficacy and side effects magnetic seizure therapy (MST) and electroconvulsive therapy (ECT) in Bipolar Depression (MST-BpD) and Treatment Resistant Depression (MST-TRD).

Being tested
magnetic seizure therapy (MST), electroconvulsive therapy (ECT)
Medical subject headings
Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • magnetic seizure therapy (MST)Device

    MST will be performed with the MagPro XP (120 V) device under anesthesia 2-3 times a week up to 15 sessions.Treatment is performed by magnetic stimulation of both hemispheres inducing a focal stimulation above vertex, using a serial of pulse trains with a frequency of at least 25 Hz but up to 100 Hz for 4-6 s (up to 10 s), which is sufficient to induce a tonic clonic seizure.

  • electroconvulsive therapy (ECT)Device

    ECT will be performed with MECTA 5000Q, 4th generation ECT devices provided by MECTA Corporation under anesthesia 2-3 times a week up to 15 sessions. For initial procedure Seizure Threshold (ST) will be estimated by empiric titration in the first session of each participant. ST will be then determined as by the manufacturer of ECT Device by the titration schedule for the initial titration session. The subsequent treatment sessions were dosed at 6 times the charge of the seizure threshold.

Study groups in NCT04080778
Study groupRoleWhat they receive
magnetic seizure therapy (MST)ExperimentalNot described
Receives: Device: magnetic seizure therapy (MST)
electroconvulsive therapy (ECT)Active comparatorNot described
Receives: Device: electroconvulsive therapy (ECT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants who go into remission

    Remission is defined as a score of 4 or below as assessed by The Severity Measure for Depression-Adult measure (adapted from the Patient Health Questionnaire-9 [PHQ-9]). The Severity Measure for Depression-Adult measure is a 9-item scale, and each item on the measure is rated on a 4-point scale. The total score ranges from 0 to 27, with higher scores indicating greater severity of depression.

    Measured: From baseline to week 6

Secondary outcomes (1)
  1. Change in cognitive impairment as measured by the Montreal Cognitive Assessment (MoCA)

    Total score on the Montreal Cognitive Assessment (MoCA) range from 0 to 30, with a higher score indicating a better outcome.

    Measured: Baseline, week 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2019
  2. Study start24 Aug 2024
  3. Primary completion30 Dec 2027 (estimated)
  4. Study completion30 Dec 2027 (estimated)

Resources

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04080778
Sponsor's protocol ID
HSC-MS-19-0468
Status last verified
Nov 2025
First submitted
23 Aug 2019
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing magnetic seizure therapy (MST) and electroconvulsive therapy (ECT) in people with Bipolar Disorder, run by Joao L. DeQuevedo 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 10 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 3 Dec 2025. 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.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Joao L. De Quevedo, MD, PhD ((713) 486-2705, Joao.L.DeQuevedo@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who go into remission (time frame: From baseline to week 6). 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 3 Dec 2025.

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