Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06423430
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-16
Brief Title:
Treatment ResistAnt Depression Subcallosal CingulatE Network DBS TRANSCEND
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
Treatment ResistAnt Depression Subcallosal CingulatE Network DBS
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRANSCEND
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None