Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Abbott Medical Devices
Study ID
NCT06423430
Status
Recruiting
Apply to this trial

Conditions

  • Treatment Resistant Depression

Eligibility Criteria

Sex
ALL
Age
22 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Sham-stimulation — DEVICE
    Sham-stimulation
  • Active-stimulation — DEVICE
    Active DBS

Study Details

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.

Key Dates

Start date
Sep 11, 2024
Status verified
Sep 2025
Primary completion
Apr 30, 2027
Completion
Apr 30, 2029

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • Active Comparator: Active-stimulation group
    Group will have DBS system activated 2 weeks post-implant.

Primary Outcome Measure

Change in MADRS total score [ Time Frame: 12 months ]

Central Contacts

Locations (24)

FacilityCityStateZIPSite coordinators
University of Alabama at Birmingham - Dept. of PsychiatryBirminghamAlabama35294
Samantha White
[email protected]
205-975-8542
Matthew Macaluso (PRINCIPAL_INVESTIGATOR)
UCLA Department of PsychiatryLos AngelesCalifornia90095
Doan Ngo
[email protected]
310-825-7797
Andrew Leuchter, MD (PRINCIPAL_INVESTIGATOR)
USC University HospitalLos AngelesCalifornia90033
Janet Sobell
[email protected]
213-740-6000
Adam Frank, MD (PRINCIPAL_INVESTIGATOR)
University of California at DavisSacramentoCalifornia95817
Jessica Anne Beatty
[email protected]
916-551-3243
David Brandman, MD (PRINCIPAL_INVESTIGATOR)
USF HealthTampaFlorida33613
Angela McDowell
[email protected]
813-440-9438
Ryan Wagoner, MD (PRINCIPAL_INVESTIGATOR)
Emory University HospitalAtlantaGeorgia30322
Sinead Quinn
[email protected]
404-727-9228
Patricio Riva Posse, MD (PRINCIPAL_INVESTIGATOR)
Rush University Medical CenterChicagoIllinois60612
Linda Skaggs
[email protected]
312-942-5592
John Zajecka, MD (PRINCIPAL_INVESTIGATOR)
Indiana UniversityIndianapolisIndiana46202
Caiden Eastmond
[email protected]
317-278-4771
Susan Conroy, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Domenic Annand, RC
[email protected]
617-632-7031
Joshua Aronson, MD (PRINCIPAL_INVESTIGATOR)
Massachusetts General HospitalBostonMassachusetts02114
Catherine Schuessler
[email protected]
617-643-7690
Cristina Cusin, MD (PRINCIPAL_INVESTIGATOR)
University of Minnesota Medical Center FairviewMinneapolisMinnesota55455
alik Widge, MD
[email protected]
612-625-7594
Alik Widge, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicRochesterMinnesota55905
Adam Loudermilk
[email protected]
Kendall Lee, MD (PRINCIPAL_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
Hunter Brown
[email protected]
314-747-7348
Charles Conway, MD (PRINCIPAL_INVESTIGATOR)
Robert Wood Johnson University HospitalNew BrunswickNew Jersey08901
Christine Yohn
[email protected]
908-328-4210
Robert Gross, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai HospitalNew YorkNew York10019
Isha Trivedi
[email protected]
212-523-8242
Martijn Figee, MD (PRINCIPAL_INVESTIGATOR)
The Cleveland Clinic FoundationClevelandOhio44195
Brian Barnett, MD
[email protected]
216-636-5860
Brian Barnett, MD (PRINCIPAL_INVESTIGATOR)
The Ohio State UniversityColumbusOhio43210
Ann-Marie Duchemin
[email protected]
614-293-5517
Kevin Reeves, MD (PRINCIPAL_INVESTIGATOR)
Pennsylvania HospitalPhiladelphiaPennsylvania19107
Mark Moran
[email protected]
240-713-2717
Casey Halpern, MD (SUB_INVESTIGATOR)
Katherine W Scangos, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29425
Morgan Dancy
[email protected]
843-876-5141
Mark George, MD (PRINCIPAL_INVESTIGATOR)
University of Texas Southwestern Medical Center at DallasDallasTexas75390
Tashinga Mupambo
[email protected]@utsouthwestern.edu
214-645-1355
Kala Bailey, MD (PRINCIPAL_INVESTIGATOR)
CHI St. Luke's Health Baylor College of Medicine Med. CtrHoustonTexas77030
Autumn Hildebrand
[email protected]
Wayne Goodman, MD (PRINCIPAL_INVESTIGATOR)
The Methodist HospitalHoustonTexas77030
346.238.6424
Amir Faraji, MD (PRINCIPAL_INVESTIGATOR)
University of Utah HospitalSalt Lake CityUtah84132
Valentina Biscounti
[email protected]
801-587-8972
Brian Mickey, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Kaitlin Goetschel
[email protected]
414-955-7398
Kunal Gupta, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham - Dept. of Psychiatry· Birmingham, ALUCLA Department of Psychiatry· Los Angeles, CAUSC University Hospital· Los Angeles, CAUniversity of California at Davis· Sacramento, CAUSF Health· Tampa, FLEmory University Hospital· Atlanta, GA

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