Treatment Resistant DepressionTRANSCENDNCT06423430
Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
A study testing Active-stimulation in people with Treatment Resistant Depression, run by Abbott Medical Devices at 26 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Treatment Resistant Depression
- What is being tested?
- Active-stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 26 sitesUnited States
- Study dates
- 11 Sep 2024to Apr 2029
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must be diagnosed with non-psychotic unipolar Major Depressive Disorder.
- The patient must be in a major depressive episode for ≥12 months or have had at least 3 lifetime depressive episodes.
- The patient has tried and failed a minimum of four different types of antidepressant treatments as measured by a tool designed for this purpose.
- Depression medication and treatment regimen must be stable for a minimum of 4 weeks before the first baseline visit
Who cannot join
- Pregnant or those who plan to become pregnant during study
- 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.
- Current or lifetime history of psychotic features in any Major Depressive Episode.
- Has an intracranial Central Nervous System disease that impairs motor, sensory or cognitive function or that requires intermittent or chronic medication.
- Significant acute suicide risk.
- Diagnosis of Substance Use Disorder or Alcohol Use Disorder without sustained remission (12 months or longer).
- Current and ongoing use of neurostimulation treatment that may interfere with DBS therapy/system.
- Treatment with another investigational device or investigational drugs.
Trial locations and contacts
26 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Lyndahl Himes contact
26 sites in 1 country
United States26 sites, 26 recruiting
- Recruiting
Emory University Hospital
Atlanta, Georgia, 30322
Sinead Quinn, 404-727-9228, scquinn@emory.edu
Patricio Riva Posse, MD
- Recruiting
University of Texas Austin Dell Medical School
Austin, Texas, 78701
Amanda Winchester, 512-232-3596, amanda.winchester@austin.utexas.edu
Ali Arian, 512-232-1791, aliarain@austin.utexas.edu
- Recruiting
University of Alabama at Birmingham - Dept. of Psychiatry
Birmingham, Alabama, 35294
Kristine Pike, 2059758542, kristinepike@uabmc.edu
Matthew Macaluso
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Catherine Schuessler, 617-643-7690, cschuessler@mgh.harvard.edu
Cristina Cusin, MD
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Barshana Karki, 617-632-7028, bkarki@bidmc.harvard.edu
Joshua Aronson, MD
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Morgan Dancy, 843-876-5141, maddoxm@musc.edu
Mark George, MD
- Recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Linda Skaggs, 312-942-5592, Linda_skaggs@rush.edu
John Zajecka, MD
- Not yet recruiting
University of Chicago
Chicago, Illinois, 60637
Sofia Vicenzino, 773-702-9066, Sofia.Vicenzino@bsd.uchicago.edu
Peter Warnke
- Recruiting
The Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Katelyn Schwesinger, 216-425-7426, schwesk@ccf.org
Brian Barnett, MD
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
Gilles Fontgalland, gilles.fontgalland@osumc.edu
Kevin Reeves, MD
- Recruiting
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75390
Nadia Imran, 214-648-7585, nadia.imran@utsouthwestern.edu
Kala Bailey, MD
- Recruiting
CHI St. Luke's Health Baylor College of Medicine Med. Ctr
Houston, Texas, 77030
Autumn Hildebrand, Autumn.hildebrand@bcm.edu
Wayne Goodman, MD
- Recruiting
The Methodist Hospital
Houston, Texas, 77030
Amber Behne, 346.238.6424, abehne@houstonmethodist.org
Amir Faraji, MD
- Recruiting
Indiana University
Indianapolis, Indiana, 46202
Rebekah Dage, 4633279491, bdage@iu.edu
Susan Conroy, MD
- Recruiting
USC University Hospital
Los Angeles, California, 90033
Janet Sobell, (424)240-9310, sobell@med.usc.edu
Adam Frank, MD
- Recruiting
UCLA Department of Psychiatry
Los Angeles, California, 90095
Doan Ngo, 310-825-7797, ThucDoanNgo@mednet.ucla.edu
Andrew Leuchter, MD
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Kaitlin Goetschel, 414-955-7398, kgoetschel@mcw.edu
Kunal Gupta, MD
- Recruiting
University of Minnesota Medical Center Fairview
Minneapolis, Minnesota, 55455
Victoria Pipia, MD, 262-366-3918, pipia006@umn.edu
Alik Widge, MD
- Recruiting
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Christine Yohn, 908-328-4210, cy253@rwjms.rutgers.edu
Robert Gross, MD
- Recruiting
Mount Sinai Hospital
New York, New York, 10019
Ellie Rapp, ellie.rapp@mssm.edu
Martijn Figee, MD
- Recruiting
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
Austin Moran, 215-829-6720, austin.moran@pennmedicine.upenn.edu
Casey Halpern, MD
- Recruiting
Mayo Clinic
Rochester, Minnesota, 55905
Lesley Riess, 507-284-5775, Riess.Lesley@mayo.edu
Kendall Lee, MD
- Recruiting
University of California at Davis
Sacramento, California, 95817
Jessica Anne Beatty, 916-551-3243, jabeatty@ucdavis.edu
David Brandman, MD
- Recruiting
University of Utah Hospital
Salt Lake City, Utah, 84132
Valentina Biscounti, 801-587-8972, angelavalentina.bisconti@utah.edu
Brian Mickey, MD
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Hunter Brown, 314-747-7348, hunterb@wustl.edu
Charles Conway, MD
- Recruiting
USF Health
Tampa, Florida, 33613
Yvonne Bannon, 813-974-2832, ybannon@usf.edu
Ryan Wagoner, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Treatment Resistant Depression
- Being tested
- Sham-stimulation, Active-stimulation
- Keywords
- DBS, Major Depressive Disorder, Bilateral Stimulation, Antidepressant Treatment, neurostimulation, ABT-CIP-10494
- Medical subject headings
- Depressive Disorder, Treatment-Resistant, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham-stimulationDevice
Sham-stimulation
Active-stimulationDevice
Active DBS
| Study group | Role | What they receive |
|---|---|---|
| Sham-stimulation group | Sham comparator | 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. Receives: Device: Sham-stimulation |
| Active-stimulation group | Active comparator | Group will have DBS system activated 2 weeks post-implant. Receives: Device: Active-stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in MADRS total score
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.
Measured: 12 months
CGI-I response rate
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.
Measured: 12 months
Secondary outcomes (5)
Percent time in MADRS response
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.
Measured: 12 Months
Percent time in MADRS partial response
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.
Measured: 12 Months
Percent time in CGI-I partial response
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.
Measured: 12 Months
MADRS Response Rate
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.
Measured: 12 Months
Q-LES-Q score change
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.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start11 Sep 2024
- Primary completionApr 2027 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Resistant DepressionStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Kopell, MD, Principal investigator, MOUNT SINAI HOSPITALMark George, MD, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423430
- Sponsor's protocol ID
- ABT-CIP-10494
- Acronym
- TRANSCEND
- Status last verified
- Oct 2026
- First submitted
- 16 May 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No