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New brain stimulation method could ease depression

NCT ID NCT06357832

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested a new way of using deep transcranial magnetic stimulation (Deep TMS) to treat major depression. Researchers compared the new stimulation protocol to the standard one in 104 adults with depression. The goal was to see if the new method is safe and works as well as the current approach.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Deep transcranial magnetic stimulation (Deep TMS) device
What this could lead to
If successful, this could offer a new, non-invasive treatment option for major depression that is as effective as current TMS protocols.
What could go wrong
This is a completed study comparing a new protocol to standard care, so it may not show a meaningful improvement. The results are limited to 104 participants and may not apply to all depression patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

104 people

The number who actually took part.

Started

Apr 2024

Finished

Mar 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 to 68 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Outpatients. * Men and women 22-68 years of age. * Primary Diagnostic and Statistical Manual (DSM-V) diagnosis of Major Depression, single or recurrent episode confirmed by the Quick Structured Clinical Interview for the DSM-5 Disorders (QuickSCID-5), with the additional requirements of a current episode ≥4 weeks and CGI-S ≥4. * Current depressive episode is less than 5 years in duration (the definition of an episode is demarcated by a period of ≥2 months in which the patient did not meet full criteria for the DSM-V definition of major depressive episode); * Total HDRS-21 ≥20 and Item 1 score ≥2 at the screening visit; * The patient did not respond to at least one antidepressant treatment, i.e., a minimum of 1 and a maximum of 4 antidepressant drug trials, of adequate dose and duration (defined as a minimum level of 3 on the Antidepressant Treatment History Form - Short Form (ATHF-SF)) in the current episode; or Patients who have not completed antidepressant trials of adequate dose and duration (defined as a level of 1-2 on the ATHF-SF) due to intolerance to therapy, if they have demonstrated intolerance to 2 or more antidepressant medications in the current episode. * Capable and willing to provide informed consent * Able to adhere to the treatment schedule. * Patient is stable on medication for 2 month and is not expected to change medication during the study period. * Satisfactory safety screening questionnaire for transcranial magnetic stimulation. Exclusion Criteria: * Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption); * Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated): * Depression secondary to a general medical condition, or substance-induced; * Substance abuse disorder within the past 3 months (except nicotine and caffeine). Note that use of cannabis for medical reasons in a stable regimen is permitted as long as the investigator excludes abuse of the substance. * Any psychotic disorder (lifetime), including schizoaffective disorder or major depression with psychotic features or Bipolar disorder. * Post-traumatic stress disorder (current or within the past year) * Current (within 12 months of baseline) generalized anxiety disorder, panic disorder or social anxiety disorder as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD. * Presence (within 12 months of baseline) of a personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic) as assessed by the investigator to be primary, causing a higher degree of distress or impairment than MDD. * Individuals with a significant neurological disorder or insult including (but not limited to): * Any condition likely to be associated with increased intracranial pressure * Space occupying brain lesion * Any history of seizure EXCEPT those therapeutically induced by Electroconvulsive T Therapy (ECT) or febrile seizures * History of cerebrovascular accident * Transient ischemic attack within two years * Cerebral aneurysm * Dementia * Mini Mental State Exam score of less than or equal to 24 * Parkinson's disease * Huntington's chorea * Multiple sclerosis * Individuals with a first-degree relative family history of seizure. * ECT treatment within 3 months prior to the screening visit * History of treatment with Vagus Nerve Stimulation (VNS) * History of treatment with Deep Brain Stimulation (DBS) * Use of any investigational drug within 4 weeks of the baseline visit * Present suicidal risk as assessed by the investigator or significant suicide risk based on HDRS-21 item 3 score of 3 or 4, or significant suicide risk as assessed using the Scale for Suicide Ideation (SSI), or a history of attempted suicide in the last year. * Any self-inflicted harm in the past 3 months not in the context of suicidal ideation. * Conductive, ferromagnetic or other magnetic-sensitive metals implanted in the head (excluding the mouth) or within 10 cm of the treatment coil (e.g., cochlear implants, implanted electrodes/stimulators, aneurysm clips or coils, stents, bullet fragments, shrapnel, surgical clips, fragments from welding or metal work). * Individuals who have cardiac pacemakers or active implantable electrodes/neurostimulators within 30 cm of the treatment coil. * If participating in psychotherapy, must have been in stable treatment for at least 3 months prior to entry into the study, with no anticipation of change in the frequency of therapeutic sessions, or the therapeutic focus over the duration of the rTMS trial * Clinically significant medical condition in the opinion of the Investigator. * Known or suspected pregnancy * Women who are breast-feeding * Women of childbearing potential and not using a medically accepted form of contraception when engaging in sexual intercourse.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Asha Neuromodulation Clinic

    Hyderabad, Telangana, 500032, India

  • Be'er Ya'aqov-Ness Ziona Mental Health Center

    Be’er Ya‘aqov, 70350, Israel

  • ClearPath Psychiatry

    Seattle, Washington, 98105, United States

  • Complete Mind Care of PA

    Abington, Pennsylvania, 19001, United States

  • DTMS Center LLC

    Palm Beach, Florida, 33401, United States

  • Fermata Health

    Brooklyn, New York, 11249, United States

  • Inland Psychiatric Medical Group, Inc.

    Redlands, California, 92373, United States

  • Novus Neurology

    Tuscaloosa, Alabama, 35401, United States

  • PsyCare

    South Charleston, West Virginia, 25303, United States

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