Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Treatment Resistant Depression

In brief

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.

Key facts

Study ID

NCT06423430

Run by

Abbott Medical Devices

People needed

100

Starts

2024-09-11

Expected to finish

2029-04-01

Last updated by the study team

2026-06-29

Who can join

Age: 22 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The patient must be diagnosed with non-psychotic unipolar Major Depressive Disorder.
• The patient must be in a major depressive episode for ≥12 months or have had at least 3 lifetime depressive episodes.
• The patient has tried and failed a minimum of four different types of antidepressant treatments as measured by a tool designed for this purpose.
• Depression medication and treatment regimen must be stable for a minimum of 4 weeks before the first baseline visit

You may not qualify if…

• Pregnant or those who plan to become pregnant during study
• 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.
• Current or lifetime history of psychotic features in any Major Depressive Episode.
• Has an intracranial Central Nervous System disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication.
• Significant acute suicide risk.
• Diagnosis of Substance Use Disorder or Alcohol Use Disorder without sustained remission (12 months or longer).
• Current and ongoing use of neurostimulation treatment that may interfere with DBS therapy/system.
• Treatment with another investigational device or investigational drugs.

Where it is running

• University of Alabama at Birmingham - Dept. of Psychiatry — Birmingham, Alabama, United States (enrolling)
• USC University Hospital — Los Angeles, California, United States (enrolling)
• UCLA Department of Psychiatry — Los Angeles, California, United States (enrolling)
• University of California at Davis — Sacramento, California, United States (enrolling)
• USF Health — Tampa, Florida, United States (enrolling)
• Emory University Hospital — Atlanta, Georgia, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States (enrolling)
• Indiana University — Indianapolis, Indiana, United States (enrolling)
• Massachusetts General Hospital — Boston, Massachusetts, United States (enrolling)
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (enrolling)
• University of Minnesota Medical Center Fairview — Minneapolis, Minnesota, United States (enrolling)
• Mayo Clinic — Rochester, Minnesota, United States (enrolling)
• Washington University School of Medicine — St Louis, Missouri, United States (enrolling)
• Robert Wood Johnson University Hospital — New Brunswick, New Jersey, United States (enrolling)
• Mount Sinai Hospital — New York, New York, United States (enrolling)
• The Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• The Ohio State University — Columbus, Ohio, United States (enrolling)
• Pennsylvania Hospital — Philadelphia, Pennsylvania, United States (enrolling)
• Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
• University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States (enrolling)
• CHI St. Luke's Health Baylor College of Medicine Med. Ctr — Houston, Texas, United States (enrolling)
• The Methodist Hospital — Houston, Texas, United States (enrolling)
• University of Utah Hospital — Salt Lake City, Utah, United States (enrolling)
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)

Full record on ClinicalTrials.gov

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