Treatment ResistAnt Depression Subcallosal CingulatE Network DBS
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Abbott Medical Devices
- Enrollment
- 100
- Locations
- 45
- Primary Endpoint
- Change in MADRS total score
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 22 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Sham-stimulation group
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.
Intervention: Sham-stimulation (Device)
Active-stimulation group
Group will have DBS system activated 2 weeks post-implant.
Intervention: Active-stimulation (Device)
Outcomes
Primary Outcomes
Change in MADRS total score
Time Frame: 12 months
The MADRS absolute change is measured as score change from baseline to the endpoint evaluation period. The Montgomery Asberg Depression Rating Scale (MADRS) consists of 10 items, and each item is rated on a 7-point Likert scale. The sum of the item scores produces a MADRS total score that ranges from 0 to 60, with higher scores reflecting greater depression severity.
CGI-I response rate
Time Frame: 12 months
The CGI-I response is defined as a rating of "very much improved" or "much improved." The Clinical Global Impression of Severity and Improvement (CGI-I) is a clinician-rated tool used to measure the global impression of a treatment response in a patient's by comparing their baseline condition (i.e., before DBS system implant) with their current state.
Change in MADRS total score
Time Frame: 12 months
The MADRS absolute change is measured as score change from baseline to the endpoint evaluation period. The Montgomery Asberg Depression Rating Scale (MADRS) consists of 10 items, and each item is rated on a 7-point Likert scale. The sum of the item scores produces a MADRS total score that ranges from 0 to 60, with higher scores reflecting greater depression severity.
CGI-I response rate
Time Frame: 12 months
The CGI-I response is defined as a rating of "very much improved" or "much improved." The Clinical Global Impression of Severity and Improvement (CGI-I) is a clinician-rated tool used to measure the global impression of a treatment response in a patient's by comparing their baseline condition (i.e., before DBS system implant) with their current state.
Secondary Outcomes
- Percent time in MADRS response(12 Months)
- Percent time in MADRS partial response(12 Months)
- Percent time in CGI-I partial response(12 Months)
- MADRS Response Rate(12 Months)
- Q-LES-Q score change(12 Months)
- Percent time in MADRS response(12 Months)
- Percent time in MADRS partial response(12 Months)
- Percent time in CGI-I partial response(12 Months)
- MADRS Response Rate(12 Months)
- Q-LES-Q score change(12 Months)