RECRUITING

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

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Conditions

Treatment Resistant DepressionDBSMajor Depressive DisorderBilateral StimulationAntidepressant TreatmentneurostimulationABT-CIP-10494

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS

Quick Facts

Study Start:2024-09-11
Study Completion:2029-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06423430

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.

Ages Eligible for Study:22 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. The patient must be diagnosed with non-psychotic unipolar Major Depressive Disorder.
  2. 2. The patient must be in a major depressive episode for ≥12 months or have had at least 3 lifetime depressive episodes.
  3. 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. 4. Depression medication and treatment regimen must be stable for a minimum of 4 weeks before the first baseline visit
  5. *
  1. 1. Pregnant or those who plan to become pregnant during study
  2. 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. 3. Current or lifetime history of psychotic features in any Major Depressive Episode.
  4. 4. Has an intracranial Central Nervous System disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication.
  5. 5. Significant acute suicide risk.
  6. 6. Diagnosis of Substance Use Disorder or Alcohol Use Disorder without sustained remission (12 months or longer).
  7. 7. Current and ongoing use of neurostimulation treatment that may interfere with DBS therapy/system.
  8. 8. Treatment with another investigational device or investigational drugs.

Contacts and Locations

Study Contact

Bradley White
CONTACT
+6164432812
bradley.white@abbott.com
Lyndahl Himes
CONTACT
lyndahl.himes@abbott.com

Principal Investigator

Brian Kopell, MD
PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Mark George, MD
PRINCIPAL_INVESTIGATOR
Medical University of South Carolina

Study Locations (Sites)

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
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
United States
Mount Sinai Hospital
New York, New York, 10019
United States
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
United States
Medical University of South Carolina
Charleston, South Carolina, 29425
United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390
United States
CHI St. Luke's Health Baylor College of Medicine Med. Ctr
Houston, Texas, 77030
United States
The Methodist Hospital
Houston, Texas, 77030
United States
University of Utah Hospital
Salt Lake City, Utah, 84132
United States

Collaborators and Investigators

Sponsor: Abbott Medical Devices

  • Brian Kopell, MD, PRINCIPAL_INVESTIGATOR, MOUNT SINAI HOSPITAL
  • Mark George, MD, PRINCIPAL_INVESTIGATOR, Medical University of South Carolina

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-11
Study Completion Date2029-04

Study Record Updates

Study Start Date2024-09-11
Study Completion Date2029-04

Terms related to this study

Keywords Provided by Researchers

  • DBS
  • Major Depressive Disorder
  • Bilateral Stimulation
  • Antidepressant Treatment
  • neurostimulation
  • ABT-CIP-10494

Additional Relevant MeSH Terms

  • Treatment Resistant Depression