Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

NCT06423430 · tracked via the Priya Life Science USA tracker

Sponsor

Abbott Medical Devices

Phase

Not applicable

Started

2024-09-11

Last updated

2026-08-28

Condition(s) studied

Treatment Resistant Depression

Investigational drug(s) / intervention(s)

Sham-stimulationActive-stimulation

Sham-stimulation: Sham-stimulation

Active-stimulation: Active DBS

Study 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

Sex

ALL

Min age

22 Years

Max age

70 Years

Healthy volunteers

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.

Primary outcome measure(s)

Change in MADRS total score — 12 months
The MADRS absolute change is measured as score change from baseline to the endpoint evaluation period. The Montgomery Asberg Depression Rating Scale (MADRS) consists of 10 items, and each item is rated on a 7-point Likert scale. The sum of the item scores produces a MADRS total score that ranges from 0 to 60, with higher scores reflecting greater depression severity.
CGI-I response rate — 12 months
The CGI-I response is defined as a rating of "very much improved" or "much improved." The Clinical Global Impression of Severity and Improvement (CGI-I) is a clinician-rated tool used to measure the global impression of a treatment response in a patient's by comparing their baseline condition (i.e., before DBS system implant) with their current state.

Trial sites (25)

Facility	City	Region	Status
University of Alabama at Birmingham - Dept. of Psychiatry	Birmingham	Alabama	Recruiting
USC University Hospital	Los Angeles	California	Not Yet Recruiting
UCLA Department of Psychiatry	Los Angeles	California	Recruiting
University of California at Davis	Sacramento	California	Recruiting
USF Health	Tampa	Florida	Recruiting
Emory University Hospital	Atlanta	Georgia	Recruiting
Rush University Medical Center	Chicago	Illinois	Recruiting
Indiana University	Indianapolis	Indiana	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
Beth Israel Deaconess Medical Center	Boston	Massachusetts	Recruiting
University of Minnesota Medical Center Fairview	Minneapolis	Minnesota	Not Yet Recruiting
Mayo Clinic	Rochester	Minnesota	Recruiting
Washington University School of Medicine	St Louis	Missouri	Recruiting
Robert Wood Johnson University Hospital	New Brunswick	New Jersey	Recruiting
Mount Sinai Hospital	New York	New York	Recruiting
The Cleveland Clinic Foundation	Cleveland	Ohio	Recruiting
The Ohio State University	Columbus	Ohio	Recruiting
Pennsylvania Hospital	Philadelphia	Pennsylvania	Recruiting
Medical University of South Carolina	Charleston	South Carolina	Recruiting
University of Texas Austin Dell Medical School	Austin	Texas	Recruiting
University of Texas Southwestern Medical Center at Dallas	Dallas	Texas	Recruiting
CHI St. Luke's Health Baylor College of Medicine Med. Ctr	Houston	Texas	Recruiting
The Methodist Hospital	Houston	Texas	Recruiting
University of Utah Hospital	Salt Lake City	Utah	Recruiting
Medical College of Wisconsin	Milwaukee	Wisconsin	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06423430 on ClinicalTrials.gov ↗ ← All trials in the USA