RecruitingNot applicable

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

CA

FL

GA

IL

IN

MA

MN

MO

NJ

NY

OH

PA

SC

TX

UT

WI