Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-02-20 @ 12:55 PM
Study NCT ID:
NCT02452892
Status:
COMPLETED
Last Update Posted:
2017-12-05
First Post:
2015-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)
Sponsor:
Tal Medical, Inc.
Organization:
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:
False
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?: