Ignite Creation Date:
2024-05-06 @ 1:14 AM
Last Modification Date:
2024-10-26 @ 11:01 AM
Study NCT ID:
NCT01760681
Status:
UNKNOWN
Last Update Posted:
2013-01-04
First Post:
2012-12-18
Brief Title:
A Randomized Sham-Controlled Study of H-Coil Repetitive Transcranial Magnetic Stimulation for Treatment-Resistant Late-Life Depression
Sponsor:
Shalvata Mental Health Center
Organization:
Shalvata Mental Health Center
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2012-06
Last Known Status:
NOT_YET_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:
The purpose of the study is to explore the efficacy and safety of H-Coil rTMS in comparison to a sham H-Coil rTMS in older patients with treatment-resistant major depressive disorderSubjects will be randomized to receive H1-Coil rTMS or sham H1-Coil rTMS The acute treatment phase will last four weeks Treatment is administered daily 5 days per week ie 20 treatments Depressive symptoms will be assessed using the HDRS-24 If subjects achieve the pre-defined primary outcome criteria of remission HDRS-24 score 10 and 60 reduction in symptoms they will continue with twice weekly treatment for two more weeks to ensure the durability of the remission Subjects who do not achieve remission will exit the study after the acute treatment phase of four weeks The blind will not be broken to subjects until the completion of the study
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