Recruiting
Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
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.
ClinicalTrials.gov IDNCT06423430
PhaseNA
Enrollment100
SponsorAbbott Medical Devices
Age22 Years
SexALL
Conditions studied
Treatment Resistant Depression
About this study
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.
Interventions
- Device: Sham-stimulation — Sham-stimulation
- Device: Active-stimulation — Active DBS
Primary outcomes
- Change in MADRS total score (12 months)
- CGI-I response rate (12 months)
Eligibility information
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 locations
- 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
- USF Health, Tampa, Florida 33613 United States
- Emory University Hospital, Atlanta, Georgia 30322 United States
- Rush University Medical Center, Chicago, Illinois 60612 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
Showing 10 of 25 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.