Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
Start Date
9/11/2024
Completion Date
4/1/2029
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.
Eligibility Criteria
Age Range: 22 years to 70 years
Interventions
Sham-stimulation
Active-stimulation
Conditions
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
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota 55455
United States
Mayo Clinic
Rochester, Minnesota 55905
United States
Washington University School of Medicine
St 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
The Ohio State University
Columbus, Ohio 43210
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
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States