Ignite Creation Date:
2024-05-06 @ 4:06 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02452892
Status:
COMPLETED
Last Update Posted:
2017-12-05
First Post:
2015-05-19
Brief Title:
Low Field Magnetic Stimulation LFMS in Subjects With Treatment-Resistant Depression TRD
Sponsor:
Tal Medical Inc
Organization:
Tal Medical Inc
Study Overview
Official Title:
A Phase 2 Multicenter Double-Blind Placebo-Controlled Dose Optimization Study of Low Field Magnetic Stimulation LFMS in Subjects With Treatment-Resistant Depression TRD
Status:
COMPLETED
Status Verified Date:
2017-09
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:
The purpose of this study is to compare the relative effectiveness of 20 and 60 minutes of Low-Field Magnetic Stimulation in relieving symptoms in patients with major depression who are treatment resistant
Detailed Description:
The primary objective of this study
To compare the relative efficacy as measured by a change in the 6-item Hamilton Rating Scale for Depression HAM-D6 of 20 and 60 minutes of LFMS compared to sham placebo in subjects with treatment resistant depression TRD
Secondary objectives
To determine if subjects with TRD may respond to 120 minutes of LFMS
To determine the persistence of response to LFMS therapy during the observation period
To evaluate the safety and tolerability of LFMS
To compare the relative efficacy as measured by a change in the 6-item Hamilton Rating Scale for Depression HAM-D6 of 20 and 60 minutes of LFMS compared to sham placebo in subjects with treatment resistant depression TRD
Secondary objectives
To determine if subjects with TRD may respond to 120 minutes of LFMS
To determine the persistence of response to LFMS therapy during the observation period
To evaluate the safety and tolerability of LFMS
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