Clinical trial NCT06423430: Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
Official title: Treatment ResistAnt Depression Subcallosal CingulatE Network DBS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Treatment Resistant Depression
Keywords: DBS
Major Depressive Disorder
Bilateral Stimulation
Antidepressant Treatment
neurostimulation
ABT-CIP-10494
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2024-05-21
Enrollment: 100
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: * 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 outcomes:
measure: The primary effectiveness endpoint: Montgomery Asberg Depression Rating Scale (MADRS) Rate of Response
timeFrame: 12 months
Secondary outcomes:
measure: MADRS Response Rates
timeFrame: 12 months
measure: Change in MADRS Score
timeFrame: 12 months
measure: MADRS Remission Rates
timeFrame: 12 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham - Dept. of Psychiatry
state: Alabama
city: Los Angeles
country: United States
facility: USC University Hospital
state: California
city: Los Angeles
country: United States
facility: UCLA Department of Psychiatry
state: California
city: Sacramento
country: United States
facility: University of California at Davis
state: California
city: Tampa
country: United States
facility: USF Health
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center Fairview
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New Brunswick
country: United States
facility: Robert Wood Johnson University Hospital
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
city: Philadelphia
country: United States
facility: Pennsylvania Hospital
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: CHI St. Luke's Health Baylor College of Medicine Med. Ctr
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Brian Kopell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Mark George, MD
role: PRINCIPAL_INVESTIGATOR
References: