Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
TRANSCEND
1 other identifier
interventional
100
1 country
28
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2024
Longer than P75 for not_applicable
28 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2024
CompletedFirst Posted
Study publicly available on registry
May 21, 2024
CompletedStudy Start
First participant enrolled
September 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2029
April 15, 2026
September 1, 2025
2.6 years
May 16, 2024
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change in MADRS total score
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.
12 months
CGI-I response rate
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.
12 months
Secondary Outcomes (5)
Percent time in MADRS response
12 Months
Percent time in MADRS partial response
12 Months
Percent time in CGI-I partial response
12 Months
MADRS Response Rate
12 Months
Q-LES-Q score change
12 Months
Study Arms (2)
Sham-stimulation group
SHAM COMPARATORGroup will be implanted with DBS system but device is not activated for the first 12 months. After 12 months, this group can receive stimulation.
Active-stimulation group
ACTIVE COMPARATORGroup will have DBS system activated 2 weeks post-implant.
Interventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (28)
University of Alabama at Birmingham - Dept. of Psychiatry
Birmingham, Alabama, 35294, United States
USC University Hospital
Los Angeles, California, 90033, United States
UCLA Department of Psychiatry
Los Angeles, California, 90095, United States
University of California at Davis
Sacramento, California, 95817, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030, United States
USF Health
Tampa, Florida, 33613, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
University of Chicago
Chicago, Illinois, 60637, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
Mount Sinai Hospital
New York, New York, 10019, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
The Ohio State University
Columbus, Ohio, 43210, United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
University of Texas Austin Dell Medical School
Austin, Texas, 78712, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
CHI St. Luke's Health Baylor College of Medicine Med. Ctr
Houston, Texas, 77030, United States
The Methodist Hospital
Houston, Texas, 77030, United States
University of Utah Hospital
Salt Lake City, Utah, 84132, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Kopell, MD
MOUNT SINAI HOSPITAL
- PRINCIPAL INVESTIGATOR
Mark George, MD
Medical University of South Carolina
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2024
First Posted
May 21, 2024
Study Start
September 11, 2024
Primary Completion (Estimated)
April 1, 2027
Study Completion (Estimated)
April 1, 2029
Last Updated
April 15, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share