Major Depressive Disorder (MDD) Clinical Trial
Official title:
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)
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.
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.
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