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Clinical Trials in the USA / NCT06423430
Recruiting Not applicable

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

NCT06423430 · tracked via the Priya Life Science USA tracker
Sponsor
Abbott Medical Devices
Phase
Not applicable
Started
2024-09-11
Last updated
2026-10-16

Condition(s) studied

Treatment Resistant Depression

Investigational drug(s) / intervention(s)

Sham-stimulationActive-stimulation

Sham-stimulation: Sham-stimulation

Active-stimulation: Active DBS

Study 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.

Eligibility

Sex
ALL
Min age
22 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change in MADRS total score — 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.
  • CGI-I response rate — 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.

Trial sites (26)

FacilityCityRegionStatus
University of Alabama at Birmingham - Dept. of Psychiatry Birmingham Alabama Recruiting
USC University Hospital Los Angeles California Recruiting
UCLA Department of Psychiatry Los Angeles California Recruiting
University of California at Davis Sacramento California Recruiting
USF Health Tampa Florida Recruiting
Emory University Hospital Atlanta Georgia Recruiting
Rush University Medical Center Chicago Illinois Recruiting
University of Chicago Chicago Illinois Not Yet Recruiting
Indiana University Indianapolis Indiana Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Beth Israel Deaconess Medical Center Boston Massachusetts Recruiting
University of Minnesota Medical Center Fairview Minneapolis Minnesota Recruiting
Mayo Clinic Rochester Minnesota Recruiting
Washington University School of Medicine St Louis Missouri Recruiting
Robert Wood Johnson University Hospital New Brunswick New Jersey Recruiting
Mount Sinai Hospital New York New York Recruiting
The Cleveland Clinic Foundation Cleveland Ohio Recruiting
The Ohio State University Columbus Ohio Recruiting
Pennsylvania Hospital Philadelphia Pennsylvania Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
University of Texas Austin Dell Medical School Austin Texas Recruiting
University of Texas Southwestern Medical Center at Dallas Dallas Texas Recruiting
CHI St. Luke's Health Baylor College of Medicine Med. Ctr Houston Texas Recruiting
The Methodist Hospital Houston Texas Recruiting
University of Utah Hospital Salt Lake City Utah Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting

More Abbott Medical Devices trials in the USA

Abbott DBS Post-Market Study of Outcomes for Indications Over Time Recruiting
TRILUMINATE Pivotal Trial Active, not recruiting
SyncAV Post-Market Trial Active, not recruiting
LIFE-BTK PK Sub-study Active, not recruiting
LIFE-BTK Randomized Controlled Trial Active, not recruiting

Other trials for the same condition

A Randomized, Double-Blind Controlled Comparison of NRX-101 vs. Placebo for Adults Being Treated With Robotic Transcranial Magnetic Stimulation for Treatment Resistant Depression: The SPARC-TMS Trial Recruiting
Efficacy, Safety, and Tolerability of Two Administrations of COMP360 in Participants With TRD Active, not recruiting
Studying Patterns in Patient Engagement Among Treatment Resistant Depression Patients Starting soon
A Prospective, Multi-center, Randomized Controlled Blinded Trial Demonstrating the Safety and Effectiveness of VNS Therapy® System as Adjunctive Therapy Versus a No Stimulation Control in Subjects With Treatment-Resistant Depression Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06423430 on ClinicalTrials.gov ↗ ← All trials in the USA