RecruitingNot ApplicableNCT06423430

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS

Sponsor

Abbott Medical Devices

Enrollment

100 participants

Start Date

Sep 11, 2024

Study Type

INTERVENTIONAL

Conditions

Treatment Resistant Depression

Summary

The goal of this clinical trial is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using Deep Brain Stimulation (DBS) as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) in adults.

Eligibility

Min Age: 22 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study (called TRANSCEND) is testing deep brain stimulation (DBS) — a small device implanted in the brain — as a treatment for people with severe depression that has not responded to other treatments. DBS delivers small electrical pulses to a specific brain region to help regulate mood. **You may be eligible if...** - You have been diagnosed with major depressive disorder (without psychosis) - You have been in a depressive episode for at least 12 months, or have had 3 or more lifetime episodes - You have tried and failed at least four different types of antidepressant treatments - Your current medications have been stable for at least 4 weeks **You may NOT be eligible if...** - You are pregnant or plan to become pregnant during the study - You have a history of psychotic symptoms during depression - You have significant suicidal risk - You have an active substance use disorder (without at least 12 months of remission) - You have another brain condition affecting motor or cognitive function - You are currently using other neurostimulation devices Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESham-stimulation

Sham-stimulation

DEVICEActive-stimulation

Active DBS

Locations(28)

University of Alabama at Birmingham - Dept. of Psychiatry

Birmingham, Alabama, United States

USC University Hospital

Los Angeles, California, United States

UCLA Department of Psychiatry

Los Angeles, California, United States

University of California at Davis

Sacramento, California, United States

University of Connecticut Health Center

Farmington, Connecticut, United States

USF Health

Tampa, Florida, United States

Emory University Hospital

Atlanta, Georgia, United States

Rush University Medical Center

Chicago, Illinois, United States

University of Chicago

Chicago, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States

Mount Sinai Hospital

New York, New York, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

University of Texas Austin Dell Medical School

Austin, Texas, United States

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

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

Houston, Texas, United States

The Methodist Hospital

Houston, Texas, United States

University of Utah Hospital

Salt Lake City, Utah, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06423430

Related Trials

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

Conditions

Summary

Eligibility

Plain Language Summary

Interventions

Locations(28)

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