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Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
NCT06423430 · Abbott Medical Devices
In plain English
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Official title
Treatment ResistAnt Depression Subcallosal CingulatE Network DBS
About this study
The aim of this prospective, multi-centered, double-blind, randomized, delayed-stimulation/ Sham-stimulation controlled 12-month study is to evaluate the effectiveness and safety of bilateral stimulation of the subcallosal cingulate white matter (SCCwm) using the Infinity™ Deep Brain Stimulation (DBS) system as an adjunctive treatment of non-psychotic unipolar Major Depressive Disorder (MDD) for adults who are experiencing a Major Depressive Episode (MDE) with inadequate response to 4 or more antidepressant treatments.
In a double-blind fashion, half the subjects will receive active DBS therapy, while half will receive sham stimulation. After the 12-month endpoint, all subjects will be unblinded to their treatment group, and subjects in the control arm will receive active DBS therapy.
Eligibility criteria
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.
Study design
Enrollment target: 100 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2024-09-11
Estimated completion: 2029-04
Last updated: 2026-04-15
Interventions
Device: Sham-stimulationDevice: Active-stimulation
Primary outcomes
- • Change in MADRS total score (12 months)
- • CGI-I response rate (12 months)
Sponsor
Abbott Medical Devices · industry
Contacts & investigators
ContactBradley White · contact · bradley.white@abbott.com · +6164432812
ContactLyndahl Himes · contact · lyndahl.himes@abbott.com
InvestigatorBrian Kopell, MD · principal_investigator, MOUNT SINAI HOSPITAL
InvestigatorMark George, MD · principal_investigator, Medical University of South Carolina
All locations (28)
University of Alabama at Birmingham - Dept. of PsychiatryRecruiting
Birmingham, Alabama, United States
USC University HospitalRecruiting
Los Angeles, California, United States
UCLA Department of PsychiatryRecruiting
Los Angeles, California, United States
University of California at DavisRecruiting
Sacramento, California, United States
University of Connecticut Health CenterNot Yet Recruiting
Farmington, Connecticut, United States
USF HealthRecruiting
Tampa, Florida, United States
Emory University HospitalRecruiting
Atlanta, Georgia, United States
Rush University Medical CenterRecruiting
Chicago, Illinois, United States
University of ChicagoNot Yet Recruiting
Chicago, Illinois, United States
Indiana UniversityRecruiting
Indianapolis, Indiana, United States
Massachusetts General HospitalRecruiting
Boston, Massachusetts, United States
Beth Israel Deaconess Medical CenterRecruiting
Boston, Massachusetts, United States
University of Minnesota Medical Center FairviewRecruiting
Minneapolis, Minnesota, United States
Mayo ClinicRecruiting
Rochester, Minnesota, United States
Washington University School of MedicineRecruiting
St Louis, Missouri, United States
Robert Wood Johnson University HospitalRecruiting
New Brunswick, New Jersey, United States
Mount Sinai HospitalRecruiting
New York, New York, United States
University Hospitals Cleveland Medical CenterNot Yet Recruiting
Cleveland, Ohio, United States
The Cleveland Clinic FoundationRecruiting
Cleveland, Ohio, United States
The Ohio State UniversityNot Yet Recruiting
Columbus, Ohio, United States
Pennsylvania HospitalRecruiting
Philadelphia, Pennsylvania, United States
Medical University of South CarolinaRecruiting
Charleston, South Carolina, United States
University of Texas Austin Dell Medical SchoolNot Yet Recruiting
Austin, Texas, United States
University of Texas Southwestern Medical Center at DallasRecruiting
Dallas, Texas, United States
CHI St. Luke's Health Baylor College of Medicine Med. CtrRecruiting
Houston, Texas, United States
The Methodist HospitalRecruiting
Houston, Texas, United States
University of Utah HospitalRecruiting
Salt Lake City, Utah, United States
Medical College of WisconsinRecruiting
Milwaukee, Wisconsin, United States