NCT06423430

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS (TRANSCEND)

Treatment ResistAnt Depression Subcallosal CingulatE Network DBS

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: 22 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Treatment Resistant Depression

Interventions

Type	Name	Description
DEVICE	Sham-stimulation	Sham-stimulation
DEVICE	Active-stimulation	Active DBS

Timeline

• Start date: 2024-09-11
• Primary completion: 2027-04-01
• Completion: 2029-04-01
• First posted: 2024-05-21
• Last updated: 2026-04-15

Locations

28 sites across 1 country: United States

Regulatory

• FDA-regulated device study