Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
- Conditions
- Treatment Resistant Depression
- Interventions
- Device: Sham-stimulationDevice: Active-stimulation
- Registration Number
- NCT06423430
- Lead Sponsor
- Abbott Medical Devices
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham-stimulation group Sham-stimulation Group 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-stimulation Group will have DBS system activated 2 weeks post-implant.
- Primary Outcome Measures
Name Time Method The primary effectiveness endpoint: Montgomery Asberg Depression Rating Scale (MADRS) Rate of Response 12 months 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.
- Secondary Outcome Measures
Name Time Method MADRS Response Rates 12 months 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.
Change in MADRS Score 12 months Change in MADRS score over time
MADRS Remission Rates 12 months 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.
Trial Locations
- Locations (22)
University of Alabama at Birmingham - Dept. of Psychiatry
🇺🇸Birmingham, Alabama, United States
USC University Hospital
🇺🇸Los Angeles, California, United States
UCLA Department of Psychiatry
🇺🇸Los Angeles, California, United States
University of California at Davis
🇺🇸Sacramento, California, United States
USF Health
🇺🇸Tampa, Florida, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Minnesota Medical Center Fairview
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
Pennsylvania Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
University of Texas Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
CHI St. Luke's Health Baylor College of Medicine Med. Ctr
🇺🇸Houston, Texas, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
University of Utah Hospital
🇺🇸Salt Lake City, Utah, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States