Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320372
Status:
COMPLETED
Last Update Posted:
2015-12-23
First Post:
2006-05-01
Brief Title:
Treatment-Resistant Depression Registry
Sponsor:
Cyberonics Inc
Organization:
Cyberonics Inc
Study Overview
Official Title:
A Long-term Prospective Observational Multi-center Patient Outcome Registry to Collect Data in Patients With Treatment-resistant Depression TRD Who Are Currently in a Major Depressive Episode
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
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 registry will collect information about patients with treatment-resistant depression TRD who are currently in a major depressive episode For the purposes of this study TRD is defined as an ongoing depression lasting at least 2 years or that has recurred at least 3 times to include the current episode during the patients lifetime AND has not adequately responded to 4 or more adequate antidepressive treatments The registry will follow the clinical course and outcomes for patients with TRD who are treated with and without adjunctive used along with other treatments for depression vagus nerve stimulation VNS therapy
Detailed Description:
Enrollment of TRD patients treated with VNS Therapy will consist of patients originally enrolled in the registry as well as patients who have completed the D-21 Dosing Study and are enrolled in the Registry for Long-Term Follow-up Sites will maintain a screening log of all patients who have been screened for original TRD Registry patients
Please note that because this is a post-approval registry Cyberonics does not cover the cost of VNS Therapy implantation
Please note that because this is a post-approval registry Cyberonics does not cover the cost of VNS Therapy implantation
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