Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

Not Applicable

Recruiting

• Conditions: Treatment Resistant Depression

• Registration Number: NCT06423430
• Lead Sponsor: Abbott Medical Devices

Brief 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.

Study Timeline

• Study First Submitted: 2024-05-16
• Study First Submitted QC: 2024-05-16
• Study First Posted: 2024-05-21
• Study Start: 2024-09-11
• Status Verified: 2025-09
• Last Update Submitted: 2025-10-02
• Last Update Posted: 2025-10-06
• Primary Completion: 2027-04
• Study Completion: 2029-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Percent time in MADRS response	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.
Percent time in MADRS partial response	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.
Percent time in CGI-I partial response	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.
MADRS Response Rate	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.
Q-LES-Q score change	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.

Trial Locations

Locations (22)

University of Alabama at Birmingham - Dept. of Psychiatry; 🇺🇸 Birmingham, Alabama, United States

USC University Hospital; 🇺🇸 Los Angeles, California, United States

UCLA Department of Psychiatry; 🇺🇸 Los Angeles, California, United States

University of California at Davis; 🇺🇸 Sacramento, California, United States

USF Health; 🇺🇸 Tampa, Florida, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States

University of Minnesota Medical Center Fairview; 🇺🇸 Minneapolis, Minnesota, United States

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