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Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

Abbott Medical Devices · NCT06423430

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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
Treatment ResistAnt Depression Subcallosal CingulatE Network DBS… (NCT06423430) | Bored Studies