Life sciences · Interventional Study
ClinicalTrials.gov · October 16, 2026
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Interventional Study.
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Registry record from ClinicalTrials.gov (NCT06423430). This is a study registration, not published results. Lead sponsor: Abbott Medical Devices. Recruitment status: RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Treatment Resistant Depression. Interventions: DEVICE: Sham-stimulation; DEVICE: Active-stimulation. Primary outcome measures: Change in MADRS total score , 12 months; CGI-I response rate , 12 months. Brief 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.