Treatment Resistant Depression study: Active-stimulation
Official title Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)
ClinicalTrials.gov ID: NCT06423430
What this study is testing
- What it's testing
- This study aims to find out if a specific type of brain stimulation is safe and effective for people with severe depression.
- Who it's for
- The study is looking for adults with severe depression that has not improved with other treatments.
- What's involved
- Participants will receive deep brain stimulation, which involves placing small devices in the brain to send electrical signals.
- Time commitment
- The source text does not specify the duration or visit schedule for this study.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 to 70
You may be able to join if
- 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
You likely can't join if
- 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...
- 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...
- Significant acute suicide risk.
- Diagnosis of Substance Use Disorder or Alcohol Use Disorder without sustained remission (12 months or longer).
See the full eligibility criteria
- 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
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Los Angeles, California, United States
- Sacramento, California, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Rochester, Minnesota, United States
- St Louis, Missouri, United States
- New Brunswick, New Jersey, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Charleston, South Carolina, United States
- Austin, Texas, United States
- Dallas, Texas, United States
- Houston, Texas, United States
+ 2 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Los Angeles, California, United States; Sacramento, California, United States; Tampa, Florida, United States; Atlanta, Georgia, United States; Chicago, Illinois, United States and 16 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.