Back to Trials
NCT06423430NARecruiting

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

Abbott Medical Devices

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

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.

Interventions

DEVICE

Sham-stimulation

DEVICE

Active-stimulation

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Treatment Resistant Depression

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