NCT02452892

Low Field Magnetic Stimulation (LFMS) in Subjects With Treatment-Resistant Depression (TRD)

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Tal Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-resistant
• Depressive Disorder, Major

Interventions

Type	Name	Description
DEVICE	LFMS	Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-09-01
• Completion: 2016-10-01
• First posted: 2015-05-25
• Last updated: 2017-12-05
• Results posted: 2017-12-05

Locations

12 sites across 1 country: United States