Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
Treatment ResistAnt Depression Subcallosal CingulatE Network DBS
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 22 Years to 70 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how safe and helpful deep brain stimulation (DBS) is when added to other depression care. DBS uses electrical signals on both sides of a brain area called the subcallosal cingulate white matter. It is for adults with major depression, without bipolar disorder or psychosis, whose depression has not improved with treatment.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have major depression without bipolar disorder or psychosis (such as seeing or hearing things that are not there).
- Have a current period of major depression lasting at least 12 months, or have had at least 3 periods of depression in your life.
- Have tried at least 4 different types of antidepressant treatment that did not work, as checked with a study rating tool.
- Have no changes to depression medicines or treatment for at least 4 weeks before the first starting visit.
Who can't join
- Are pregnant or plan to become pregnant during the study.
- Have a body structure, health, social, or mental health issue that could limit participation or make study rules hard to follow.
- Have ever had psychosis, such as seeing or hearing things that are not there, during major depression.
- Have a brain disease that affects movement, senses, or thinking, or needs medicine from time to time or long term.
- Have a serious, immediate risk of suicide.
- Have a drug or alcohol use disorder that has not been in remission (under control) for at least 12 months.
- Currently use an ongoing nerve or brain stimulation treatment that could interfere with DBS.
- Are being treated with another experimental device or drug.
Simplified for readability. The official criteria below are what the study team uses.
Official 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.
Study sites (26)
AL
- University of Alabama at Birmingham - Dept. of Psychiatry · Birmingham, AL 35294Kristine Pike · Study contact · 2059758542 · kristinepike@uabmc.eduMatthew Macaluso · Principal investigatorMore trials in Birmingham
CA
- USC University Hospital · Los Angeles, CA 90033Janet Sobell · Study contact · (424)240-9310 · sobell@med.usc.eduAdam Frank, MD · Principal investigatorMore trials in Los Angeles
- UCLA Department of Psychiatry · Los Angeles, CA 90095Doan Ngo · Study contact · 310-825-7797 · ThucDoanNgo@mednet.ucla.eduAndrew Leuchter, MD · Principal investigatorMore trials in Los Angeles
- University of California at Davis · Sacramento, CA 95817Jessica Anne Beatty · Study contact · 916-551-3243 · jabeatty@ucdavis.eduDavid Brandman, MD · Principal investigatorMore trials in Sacramento
FL
- USF Health · Tampa, FL 33613Yvonne Bannon · Study contact · 813-974-2832 · ybannon@usf.eduRyan Wagoner, MD · Principal investigatorMore trials in Tampa
GA
- Emory University Hospital · Atlanta, GA 30322Sinead Quinn · Study contact · 404-727-9228 · scquinn@emory.eduPatricio Riva Posse, MD · Principal investigatorMore trials in Atlanta
IL
- Rush University Medical Center · Chicago, IL 60612Linda Skaggs · Study contact · 312-942-5592 · Linda_skaggs@rush.eduJohn Zajecka, MD · Principal investigatorMore trials in Chicago
- University of Chicago · Chicago, IL 60637Sofia Vicenzino · Study contact · 773-702-9066 · Sofia.Vicenzino@bsd.uchicago.eduPeter Warnke · Principal investigatorMore trials in Chicago
IN
- Indiana University · Indianapolis, IN 46202Rebekah Dage · Study contact · 4633279491 · bdage@iu.eduSusan Conroy, MD · Principal investigatorMore trials in Indianapolis
MA
- Massachusetts General Hospital · Boston, MA 02114Catherine Schuessler · Study contact · 617-643-7690 · cschuessler@mgh.harvard.eduCristina Cusin, MD · Principal investigatorMore trials in Boston
- Beth Israel Deaconess Medical Center · Boston, MA 02215Barshana Karki · Study contact · 617-632-7028 · bkarki@bidmc.harvard.eduJoshua Aronson, MD · Principal investigatorMore trials in Boston
MN
- University of Minnesota Medical Center Fairview · Minneapolis, MN 55455Victoria Pipia, MD · Study contact · 262-366-3918 · pipia006@umn.eduAlik Widge, MD · Principal investigatorMore trials in Minneapolis
- Mayo Clinic · Rochester, MN 55905Lesley Riess · Study contact · 507-284-5775 · Riess.Lesley@mayo.eduKendall Lee, MD · Principal investigatorMore trials in Rochester
MO
- Washington University School of Medicine · St Louis, MO 63110Hunter Brown · Study contact · 314-747-7348 · hunterb@wustl.eduCharles Conway, MD · Principal investigatorMore trials in St Louis
NJ
- Robert Wood Johnson University Hospital · New Brunswick, NJ 08901Christine Yohn · Study contact · 908-328-4210 · cy253@rwjms.rutgers.eduRobert Gross, MD · Principal investigatorMore trials in New Brunswick
NY
- Mount Sinai Hospital · New York, NY 10019Ellie Rapp · Study contact · ellie.rapp@mssm.eduMartijn Figee, MD · Principal investigatorMore trials in New York
OH
- The Cleveland Clinic Foundation · Cleveland, OH 44195Katelyn Schwesinger · Study contact · 216-425-7426 · schwesk@ccf.orgBrian Barnett, MD · Principal investigatorMore trials in Cleveland
- The Ohio State University · Columbus, OH 43210Gilles Fontgalland · Study contact · gilles.fontgalland@osumc.eduKevin Reeves, MD · Principal investigatorMore trials in Columbus
PA
- Pennsylvania Hospital · Philadelphia, PA 19107Austin Moran · Study contact · 215-829-6720 · austin.moran@pennmedicine.upenn.eduCasey Halpern, MD · Sub-investigatorKatherine W Scangos, MD · Principal investigatorMore trials in Philadelphia
SC
- Medical University of South Carolina · Charleston, SC 29425Morgan Dancy · Study contact · 843-876-5141 · maddoxm@musc.eduMark George, MD · Principal investigatorMore trials in Charleston
TX
- University of Texas Austin Dell Medical School · Austin, TX 78701Amanda Winchester · Study contact · 512-232-3596 · amanda.winchester@austin.utexas.eduAli Arian · Study contact · 512-232-1791 · aliarain@austin.utexas.eduRobert Seilheimer · Principal investigatorMore trials in Austin
- University of Texas Southwestern Medical Center at Dallas · Dallas, TX 75390Nadia Imran · Study contact · 214-648-7585 · nadia.imran@utsouthwestern.eduKala Bailey, MD · Principal investigatorMore trials in Dallas
- CHI St. Luke's Health Baylor College of Medicine Med. Ctr · Houston, TX 77030Autumn Hildebrand · Study contact · Autumn.hildebrand@bcm.eduWayne Goodman, MD · Principal investigatorMore trials in Houston
- The Methodist Hospital · Houston, TX 77030Amber Behne · Study contact · 346.238.6424 · abehne@houstonmethodist.orgAmir Faraji, MD · Principal investigatorMore trials in Houston
UT
- University of Utah Hospital · Salt Lake City, UT 84132Valentina Biscounti · Study contact · 801-587-8972 · angelavalentina.bisconti@utah.eduBrian Mickey, MD · Principal investigatorMore trials in Salt Lake City
WI
- Medical College of Wisconsin · Milwaukee, WI 53226Kaitlin Goetschel · Study contact · 414-955-7398 · kgoetschel@mcw.eduKunal Gupta, MD · Principal investigatorMore trials in Milwaukee