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Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

RecruitingNA

Sponsor: Abbott Medical Devices

Conditions: Treatment Resistant Depression

Interventions: Sham-stimulation, Active-stimulation

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 22 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (25)

Birmingham, Alabama, United States
Los Angeles, California, United States
Los Angeles, California, United States
Sacramento, California, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
New Brunswick, New Jersey, United States
New York, New York, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Milwaukee, Wisconsin, United States