Actively Recruiting

Phase Not Applicable
Age: 22Years - 70Years
All Genders
NCT06423430

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

Led by Abbott Medical Devices · Updated on 2026-04-15

100

Participants Needed

28

Research Sites

237 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

Who Can Participate

Age: 22Years - 70Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with non-psychotic unipolar Major Depressive Disorder
  • Currently in a major depressive episode lasting 12 months or more, or with at least 3 lifetime depressive episodes
  • Tried and failed at least four different types of antidepressant treatments
  • Depression medication and treatment regimen stable for at least 4 weeks before baseline visit
Not Eligible

You will not qualify if you...

  • Pregnant or planning to become pregnant during the study
  • Any other medical, social, or psychological condition that could limit study participation or adherence
  • Current or past history of psychotic features in any Major Depressive Episode
  • Intracranial Central Nervous System disease impairing motor, sensory, or cognitive function, or requiring ongoing medication
  • Significant acute suicide risk
  • Diagnosis of Substance Use Disorder or Alcohol Use Disorder without remission for 12 months or more
  • Current use of neurostimulation treatment that might interfere with DBS
  • Treatment with other investigational devices or drugs

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 28 locations

1

University of Alabama at Birmingham - Dept. of Psychiatry

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

USC University Hospital

Los Angeles, California, United States, 90033

Actively Recruiting

3

UCLA Department of Psychiatry

Los Angeles, California, United States, 90095

Actively Recruiting

4

University of California at Davis

Sacramento, California, United States, 95817

Actively Recruiting

5

University of Connecticut Health Center

Farmington, Connecticut, United States, 06030

Not Yet Recruiting

6

USF Health

Tampa, Florida, United States, 33613

Actively Recruiting

7

Emory University Hospital

Atlanta, Georgia, United States, 30322

Actively Recruiting

8

Rush University Medical Center

Chicago, Illinois, United States, 60612

Actively Recruiting

9

University of Chicago

Chicago, Illinois, United States, 60637

Not Yet Recruiting

10

Indiana University

Indianapolis, Indiana, United States, 46202

Actively Recruiting

11

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

12

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215

Actively Recruiting

13

University of Minnesota Medical Center Fairview

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

14

Mayo Clinic

Rochester, Minnesota, United States, 55905

Actively Recruiting

15

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

16

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, United States, 08901

Actively Recruiting

17

Mount Sinai Hospital

New York, New York, United States, 10019

Actively Recruiting

18

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Not Yet Recruiting

19

The Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Actively Recruiting

20

The Ohio State University

Columbus, Ohio, United States, 43210

Not Yet Recruiting

21

Pennsylvania Hospital

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

22

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Actively Recruiting

23

University of Texas Austin Dell Medical School

Austin, Texas, United States, 78712

Not Yet Recruiting

24

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States, 75390

Actively Recruiting

25

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

Houston, Texas, United States, 77030

Actively Recruiting

26

The Methodist Hospital

Houston, Texas, United States, 77030

Actively Recruiting

27

University of Utah Hospital

Salt Lake City, Utah, United States, 84132

Actively Recruiting

28

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

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Research Team

B

Bradley White

CONTACT

L

Lyndahl Himes

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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