Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

Description

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.

Conditions

Treatment Resistant Depression

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Study Overview

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Study Details

Study overview

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.

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

Condition
Treatment Resistant Depression
Intervention / Treatment

-

Contacts and Locations

Los Angeles

USC University Hospital, Los Angeles, California, United States, 90033

Los Angeles

UCLA Department of Psychiatry, Los Angeles, California, United States, 90095

Sacramento

University of California at Davis, Sacramento, California, United States, 95817

Tampa

USF Health, Tampa, Florida, United States, 33613

Atlanta

Emory University Hospital, Atlanta, Georgia, United States, 30322

Chicago

Rush University Medical Center, Chicago, Illinois, United States, 60612

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Minneapolis

University of Minnesota Medical Center Fairview, Minneapolis, Minnesota, United States, 55455

Rochester

Mayo Clinic, Rochester, Minnesota, United States, 55905

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • *
  • 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.

Ages Eligible for Study

22 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abbott Medical Devices,

Brian Kopell, MD, PRINCIPAL_INVESTIGATOR, MOUNT SINAI HOSPITAL

Mark George, MD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

2029-04