This is a prospective, multi-center, open-label study.~Up to 1000 adult subjects, in a major depressive episode, who have failed to receive satisfactory improvement from a prior antidepressant medication in the current episode, are eligible to participate in this study if they are deemed to be appropriate candidates for TMS.~Overall study duration is expected to be approximately 4 years. The study duration per subject is anticipated to be approximately 1 year.~Hypothesis: The SAINT® Neuromodulation System will demonstrate effectiveness in the treatment of MDD as measured by CGI-I at the end of the treatment (cessation of stimulation).
The goal of this observational study is to demonstrate effectiveness in the treatment of Major Depressive Disorder~The primary objective is to assess the effectiveness in the treatment of Major Depressive Disorder using the CGI-I at the end of the treatment~Participants will receive 10 treatments per day for 5 days (M-F) of SAINT®