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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Sham-stimulation
Active DBS
Change in MADRS total score
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.
Time frame: 12 months
CGI-I response rate
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.
Time frame: 12 months
Percent time in MADRS response
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.
Time frame: 12 Months
Percent time in MADRS partial response
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.
Time frame: 12 Months
Percent time in CGI-I partial response
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.
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University of Alabama at Birmingham - Dept. of Psychiatry
Birmingham, Alabama, United States
RECRUITINGUSC University Hospital
Los Angeles, California, United States
RECRUITINGUCLA Department of Psychiatry
Los Angeles, California, United States
RECRUITINGUniversity of California at Davis
Sacramento, California, United States
RECRUITINGUniversity of Connecticut Health Center
Farmington, Connecticut, United States
NOT_YET_RECRUITINGUSF Health
Tampa, Florida, United States
RECRUITINGEmory University Hospital
Atlanta, Georgia, United States
RECRUITINGRush University Medical Center
Chicago, Illinois, United States
RECRUITINGUniversity of Chicago
Chicago, Illinois, United States
NOT_YET_RECRUITINGIndiana University
Indianapolis, Indiana, United States
RECRUITING...and 18 more locations
Time frame: 12 Months
MADRS Response Rate
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.
Time frame: 12 Months
Q-LES-Q score change
The Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) is a self-report measure that assess the degree of enjoyment and satisfaction experienced by patients in various areas of daily functioning.
Time frame: 12 Months