Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
Abbott Medical Devices · NCT06423430
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 22–70 · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Not applicable
- Target enrollment
- 100
- US sites recruiting
- 25
- Study start
- September 11, 2024
- Record last updated
- October 16, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study 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.
Being studied: Sham-stimulation; Active-stimulation
Conditions: Treatment Resistant Depression
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
Recruiting US locations
University of Alabama at Birmingham - Dept. of Psychiatry
Birmingham, AL 35294
Site contact: Kristine Pike · 2059758542 · kristinepike@uabmc.edu
USC University Hospital
Los Angeles, CA 90033
Site contact: Janet Sobell · (424)240-9310 · sobell@med.usc.edu
UCLA Department of Psychiatry
Los Angeles, CA 90095
Site contact: Doan Ngo · 310-825-7797 · ThucDoanNgo@mednet.ucla.edu
University of California at Davis
Sacramento, CA 95817
Site contact: Jessica Anne Beatty · 916-551-3243 · jabeatty@ucdavis.edu
USF Health
Tampa, FL 33613
Site contact: Yvonne Bannon · 813-974-2832 · ybannon@usf.edu
Emory University Hospital
Atlanta, GA 30322
Site contact: Sinead Quinn · 404-727-9228 · scquinn@emory.edu
Rush University Medical Center
Chicago, IL 60612
Site contact: Linda Skaggs · 312-942-5592 · Linda_skaggs@rush.edu
Indiana University
Indianapolis, IN 46202
Site contact: Rebekah Dage · 4633279491 · bdage@iu.edu
Massachusetts General Hospital
Boston, MA 02114
Site contact: Catherine Schuessler · 617-643-7690 · cschuessler@mgh.harvard.edu
Beth Israel Deaconess Medical Center
Boston, MA 02215
Site contact: Barshana Karki · 617-632-7028 · bkarki@bidmc.harvard.edu
University of Minnesota Medical Center Fairview
Minneapolis, MN 55455
Site contact: Victoria Pipia, MD · 262-366-3918 · pipia006@umn.edu
Mayo Clinic
Rochester, MN 55905
Site contact: Lesley Riess · 507-284-5775 · Riess.Lesley@mayo.edu
Washington University School of Medicine
St Louis, MO 63110
Site contact: Hunter Brown · 314-747-7348 · hunterb@wustl.edu
Robert Wood Johnson University Hospital
New Brunswick, NJ 08901
Site contact: Christine Yohn · 908-328-4210 · cy253@rwjms.rutgers.edu
Mount Sinai Hospital
New York, NY 10019
Site contact: Ellie Rapp · ellie.rapp@mssm.edu
The Cleveland Clinic Foundation
Cleveland, OH 44195
Site contact: Katelyn Schwesinger · 216-425-7426 · schwesk@ccf.org
The Ohio State University
Columbus, OH 43210
Site contact: Gilles Fontgalland · gilles.fontgalland@osumc.edu
Pennsylvania Hospital
Philadelphia, PA 19107
Site contact: Austin Moran · 215-829-6720 · austin.moran@pennmedicine.upenn.edu
Medical University of South Carolina
Charleston, SC 29425
Site contact: Morgan Dancy · 843-876-5141 · maddoxm@musc.edu
University of Texas Austin Dell Medical School
Austin, TX 78701
Site contact: Amanda Winchester · 512-232-3596 · amanda.winchester@austin.utexas.edu
University of Texas Southwestern Medical Center at Dallas
Dallas, TX 75390
Site contact: Nadia Imran · 214-648-7585 · nadia.imran@utsouthwestern.edu
CHI St. Luke's Health Baylor College of Medicine Med. Ctr
Houston, TX 77030
Site contact: Autumn Hildebrand · Autumn.hildebrand@bcm.edu
The Methodist Hospital
Houston, TX 77030
Site contact: Amber Behne · 346.238.6424 · abehne@houstonmethodist.org
University of Utah Hospital
Salt Lake City, UT 84132
Site contact: Valentina Biscounti · 801-587-8972 · angelavalentina.bisconti@utah.edu
Medical College of Wisconsin
Milwaukee, WI 53226
Site contact: Kaitlin Goetschel · 414-955-7398 · kgoetschel@mcw.edu
Study contacts (from the official record)
- Natalie Danovsky · +16517563842 · natalie.richardson@abbott.com
- Lyndahl Himes · lyndahl.himes@abbott.com
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