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Brain implant trial targets severe depression

NCT ID NCT06423430

Disease control Sponsor: Abbott Medical Devices Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study tests whether deep brain stimulation (DBS) can help people with severe depression that hasn't improved with multiple treatments. Researchers will implant a device that sends electrical pulses to a specific brain area. The trial includes 100 adults and compares active stimulation to a sham (inactive) device to see if it safely reduces depression symptoms.

What this could mean

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

Active substance
deep brain stimulation (DBS) device
What this could lead to
If it works, this could offer a new option for people with severe depression that hasn't responded to other treatments.
What could go wrong
This is an early-stage trial with only 100 participants, so results may not apply to everyone. Brain surgery carries risks like infection or bleeding, and the device may not work for all.

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

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Apr 2029

An estimate. End dates often move.

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 70 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: 1. The patient must be diagnosed with non-psychotic unipolar Major Depressive Disorder. 2. The patient must be in a major depressive episode for ≥12 months or have had at least 3 lifetime depressive episodes. 3. The patient has tried and failed a minimum of four different types of antidepressant treatments as measured by a tool designed for this purpose. 4. Depression medication and treatment regimen must be stable for a minimum of 4 weeks before the first baseline visit Exclusion Criteria: 1. Pregnant or those who plan to become pregnant during study 2. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that could limit participation in the study or interfere with adherence to the study protocol. 3. Current or lifetime history of psychotic features in any Major Depressive Episode. 4. Has an intracranial Central Nervous System disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication. 5. Significant acute suicide risk. 6. Diagnosis of Substance Use Disorder or Alcohol Use Disorder without sustained remission (12 months or longer). 7. Current and ongoing use of neurostimulation treatment that may interfere with DBS therapy/system. 8. Treatment with another investigational device or investigational drugs.

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Conditions

The condition(s) this trial relates to.

Depressive Disorder, Treatment-Resistant major depressive disorder

As listed by the trial registrant

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

Treatment-resistant depression

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    25 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beth Israel Deaconess Medical Center

    RECRUITING

    Boston, Massachusetts, 02215, United States

  • CHI St. Luke's Health Baylor College of Medicine Med. Ctr

    RECRUITING

    Houston, Texas, 77030, United States

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

  • Indiana University

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

  • Mayo Clinic

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Medical College of Wisconsin

    RECRUITING

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29425, United States

  • Mount Sinai Hospital

    RECRUITING

    New York, New York, 10019, United States

  • Pennsylvania Hospital

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

  • Robert Wood Johnson University Hospital

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Rush University Medical Center

    RECRUITING

    Chicago, Illinois, 60612, United States

  • The Cleveland Clinic Foundation

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • The Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • The Ohio State University

    RECRUITING

    Columbus, Ohio, 43210, United States

  • UCLA Department of Psychiatry

    RECRUITING

    Los Angeles, California, 90095, United States

  • USC University Hospital

    NOT_YET_RECRUITING

    Los Angeles, California, 90033, United States

  • USF Health

    RECRUITING

    Tampa, Florida, 33613, United States

  • University of Alabama at Birmingham - Dept. of Psychiatry

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of California at Davis

    RECRUITING

    Sacramento, California, 95817, United States

  • University of Minnesota Medical Center Fairview

    NOT_YET_RECRUITING

    Minneapolis, Minnesota, 55455, United States

  • University of Texas Austin Dell Medical School

    RECRUITING

    Austin, Texas, 78701, United States

  • University of Texas Southwestern Medical Center at Dallas

    RECRUITING

    Dallas, Texas, 75390, United States

  • University of Utah Hospital

    RECRUITING

    Salt Lake City, Utah, 84132, United States

  • Washington University School of Medicine

    RECRUITING

    St Louis, Missouri, 63110, United States

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