Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

Launched by ABBOTT MEDICAL DEVICES · May 16, 2024

Keywords

ClinConnect Summary

The TRANSCEND trial is studying a new treatment for adults who have severe depression that hasn’t improved with standard medications. This study is looking at a technique called Deep Brain Stimulation (DBS), which involves sending small electrical signals to a specific area in the brain known as the subcallosal cingulate white matter. The goal is to see if this treatment can help those who have been struggling with major depressive episodes for a long time, especially if they have tried multiple medications without success.

To participate in this study, individuals must be diagnosed with a certain type of depression called non-psychotic unipolar Major Depressive Disorder and have had symptoms for at least a year or have experienced multiple episodes in their lifetime. They should also have tried at least four different antidepressants without finding relief. It’s important to note that pregnant individuals and those with certain other health conditions may not be eligible. Participants can expect to receive careful monitoring and support throughout the trial as researchers assess the safety and effectiveness of this new treatment approach.

Gender

ALL

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.

Trial Officials