NCT03012724

Efficacy of H7-Coil DTMS Compared to H1-Coil DTMS in Subjects With Major Depression Disorder (MDD)

A Prospective Multicenter Double Blind Randomized Controlled Trial to Demonstrate That the Efficacy of the H7-Coil is as Good as the Efficacy of the H1-Coil Deep Transcranial Magnetic Stimulation (DTMS) in Subjects With Major Depression Disorder (MDD)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Brainsway · Industry
• Sex: All
• Age: 22 Years – 68 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to demonstrate that the efficacy and safety of deep brain rTMS, (Transcranial Magnetic Stimulation) H7-Coil treatment as add on treatment, is as good as the FDA cleared, H1-Coil, in subjects with major depressive disorder that have been previously unsuccessfully treated with antidepressant medications.

Detailed description

This is a prospective, 6 week, double blind, randomized, controlled, multi-center trial. The study will explore the safety and efficacy of deep brain rTMS (Transcranial Magnetic Stimulation) H7-Coil treatment and demonstrate that it is as good as the FDA cleared, H1-Coil treatment as add-on for a treatment with antidepressant drugs (a bi-therapeutic treatment ) in subjects with major depressive disorder that have been previously unsuccessfully treated with antidepressant medication. Approximately 146 subjects will be enrolled in the study. The study population consists of subjects with MDD who have failed adequate medication treatment and who are in a current depressive episode. The patients will be of all racial, ethnic and gender categories, ranging from 22 to 68 years of age, and have HDRS-21≥20. Outpatients will be recruited from both academic and private research centers. The study duration is 8 weeks, with a 2 week period of screening and baseline, followed by 4 weeks of 5 daily treatments and 2 weeks of biweekly treatments. Mood and mental state will be carefully monitored through standard psychological scales and assessments during the screening and baseline and throughout treatment.

Conditions

• Major Depressive Disorder (MDD)

Interventions

Type	Name	Description
DEVICE	H7-Coil	Deep transcranial magnetic stimulation for the treatment of major dispersion disorder with the H7-Coil
DEVICE	H1-Coil	Deep transcranial magnetic stimulation for the treatment of major depression disorder with the FDA cleared H1-Coil

Timeline

• Start date: 2017-03-30
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2017-01-06
• Last updated: 2020-07-15

Locations

9 sites across 3 countries: United States, Canada, Israel

Regulatory

• FDA-regulated device study