Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

Abbott

Status: Enrolling

Conditions: Treatment Resistant Depression

Treatments: Device: Sham-stimulation; Device: Active-stimulation

Study type: Interventional

Funder types: Industry

Identifiers

NCT06423430

ABT-CIP-10494

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 22 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups

Sham-stimulation group

Sham Comparator group

Description:

Group will be implanted with DBS system but device is not activated for the first 12 months. After 12 months, this group can receive stimulation.

Treatment:

Device: Sham-stimulation

Active-stimulation group

Active Comparator group

Description:

Group will have DBS system activated 2 weeks post-implant.

Treatment:

Device: Active-stimulation