Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

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.

Inclusion 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

Exclusion criteria

• 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.