Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND) (TRANSCEND)

August 26, 2026 updated by: Abbott Medical Devices

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham - Dept. of Psychiatry
        • Principal Investigator:
          • Matthew Macaluso
        • Contact:
    • California
      • Los Angeles, California, United States, 90033
        • Not yet recruiting
        • USC University Hospital
        • Principal Investigator:
          • Adam Frank, MD
        • Contact:
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Department of Psychiatry
        • Principal Investigator:
          • Andrew Leuchter, MD
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California at Davis
        • Principal Investigator:
          • David Brandman, MD
        • Contact:
    • Florida
      • Tampa, Florida, United States, 33613
        • Recruiting
        • USF Health
        • Contact:
        • Principal Investigator:
          • Ryan Wagoner, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Contact:
        • Principal Investigator:
          • Patricio Riva Posse, MD
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • Rush University Medical Center
        • Principal Investigator:
          • John Zajecka, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University
        • Principal Investigator:
          • Susan Conroy, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Cristina Cusin, MD
        • Contact:
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Beth Israel Deaconess Medical Center
        • Principal Investigator:
          • Joshua Aronson, MD
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Not yet recruiting
        • University of Minnesota Medical Center Fairview
        • Principal Investigator:
          • Alik Widge, MD
        • Contact:
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic
        • Principal Investigator:
          • Kendall Lee, MD
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Principal Investigator:
          • Charles Conway, MD
        • Contact:
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Recruiting
        • Robert Wood Johnson University Hospital
        • Principal Investigator:
          • Robert Gross, MD
        • Contact:
    • New York
      • New York, New York, United States, 10019
        • Recruiting
        • Mount Sinai Hospital
        • Principal Investigator:
          • Martijn Figee, MD
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • The Cleveland Clinic Foundation
        • Principal Investigator:
          • Brian Barnett, MD
        • Contact:
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University
        • Principal Investigator:
          • Kevin Reeves, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Pennsylvania Hospital
        • Sub-Investigator:
          • Casey Halpern, MD
        • Principal Investigator:
          • Katherine W Scangos, MD
        • Contact:
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina
        • Contact:
        • Principal Investigator:
          • Mark George, MD
    • Texas
      • Austin, Texas, United States, 78701
        • Recruiting
        • University of Texas Austin Dell Medical School
        • Contact:
        • Principal Investigator:
          • Robert Seilheimer
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University Of Texas Southwestern Medical Center At Dallas
        • Principal Investigator:
          • Kala Bailey, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • The Methodist Hospital
        • Principal Investigator:
          • Amir Faraji, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • CHI St. Luke's Health Baylor College of Medicine Med. Ctr
        • Principal Investigator:
          • Wayne Goodman, MD
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah Hospital
        • Principal Investigator:
          • Brian Mickey, MD
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
        • Principal Investigator:
          • Kunal Gupta, MD

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham-stimulation group
Group will be implanted with DBS system but device is not activated for the first 12 months. After 12 months, this group can receive stimulation.
Device: Sham-stimulation
Sham-stimulation
Active Comparator: Active-stimulation group
Group will have DBS system activated 2 weeks post-implant.
Device: Active-stimulation
Active DBS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in MADRS total score
Time Frame: 12 months

The MADRS absolute change is measured as score change from baseline to the endpoint evaluation period.

The Montgomery Asberg Depression Rating Scale (MADRS) consists of 10 items, and each item is rated on a 7-point Likert scale. The sum of the item scores produces a MADRS total score that ranges from 0 to 60, with higher scores reflecting greater depression severity.
12 months
CGI-I response rate
Time Frame: 12 months
The CGI-I response is defined as a rating of "very much improved" or "much improved." The Clinical Global Impression of Severity and Improvement (CGI-I) is a clinician-rated tool used to measure the global impression of a treatment response in a patient's by comparing their baseline condition (i.e., before DBS system implant) with their current state.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent time in MADRS response
Time Frame: 12 Months
The Montgomery Asberg Depression Rating Scale (MADRS) consists of 10 items, and each item is rated on a 7-point Likert scale. The sum of the item scores produces a MADRS total score that ranges from 0 to 60, with higher scores reflecting greater depression severity.
12 Months
Percent time in MADRS partial response
Time Frame: 12 Months
The Montgomery Asberg Depression Rating Scale (MADRS) consists of 10 items, and each item is rated on a 7-point Likert scale. The sum of the item scores produces a MADRS total score that ranges from 0 to 60, with higher scores reflecting greater depression severity.
12 Months
Percent time in CGI-I partial response
Time Frame: 12 Months
The Clinical Global Impression of Severity and Improvement (CGI-I) is a clinician-rated tool used to measure the global impression of a treatment response in a patient's by comparing their baseline condition (i.e., before DBS system implant) with their current state.
12 Months
MADRS Response Rate
Time Frame: 12 Months
The Montgomery Asberg Depression Rating Scale (MADRS) consists of 10 items, and each item is rated on a 7-point Likert scale. The sum of the item scores produces a MADRS total score that ranges from 0 to 60, with higher scores reflecting greater depression severity.
12 Months
Q-LES-Q score change
Time Frame: 12 Months
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report measure that assess the degree of enjoyment and satisfaction experienced by patients in various areas of daily functioning.
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Medical Devices

Investigators

  • Principal Investigator: Mark George, MD, Medical University of South Carolina
  • Principal Investigator: Brian Kopell, MD, Mount Sinai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

September 11, 2024

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2029

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 26, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABT-CIP-10494

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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