Treatment ResistAnt Depression Subcallosal CingulatE Network DBS
Abbott Medical Devices
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.
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 thera…
Eligibility
- Age range
- 22–70 years
- Sex
- All
- Healthy volunteers
- No
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 othe…
Interventions
- DeviceSham-stimulation
Sham-stimulation
- DeviceActive-stimulation
Active DBS
Locations (28)
- University of Alabama at Birmingham - Dept. of PsychiatryBirmingham, Alabama
- USC University HospitalLos Angeles, California
- UCLA Department of PsychiatryLos Angeles, California
- University of California at DavisSacramento, California
- University of Connecticut Health CenterFarmington, Connecticut
- USF HealthTampa, Florida