Ignite Creation Date:
2024-05-06 @ 1:24 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01801319
Status:
UNKNOWN
Last Update Posted:
2017-04-26
First Post:
2013-02-26
Brief Title:
A Clinical Evaluation of Subcallosal Cingulate Gyrus Deep Brain Stimulation for Treatment-Resistant Depression
Sponsor:
Abbott Medical Devices
Organization:
Abbott Medical Devices
Study Overview
Official Title:
A Clinical Evaluation of Subcallosal Cingulate Gyrus Deep Brain Stimulation for Treatment-Resistant Depression
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized placebo-controlled double-blind cross-over trial evaluating the safety efficacy daily functioning and health-related quality of life of Subcallosal Cingulate Gyrus Deep Brain Stimulation SCG DBS for participants with Treatment-Resistant Depression TRD A total of 40 eligible participants will be randomized to four treatment sequences 10 participants per sequence Each participant will be treated over a 6-month period with active or sham stimulation in which both the participants and the attending psychiatrists will be blinded to treatment allocation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Health Canada 148956 | OTHER | Health Canada | None |