Among patients with MDD, almost 90% have moderate to very severe depression.¹ Kessler et al¹ reported that almost half of patients who experienced a depressive episode received no health care treatment during a 1-year follow-up, and of those who did, nearly 60% received inadequate treatment. Unfortunately, even among patients being treated adequately, response (ie, symptom reduction ≥ 50%)⁷ without remission is common; the STAR*D study⁸ found that initial treatment led to remission in only one-third of patients. Further, relapse occurred in 34% of patients who reached remission after 1 treatment step and 50% of patients who required 4 treatment steps to reach remission.

The impact of MDD on quality of life can be as great as or greater than that of chronic medical diseases such as diabetes.^9,10 Depending on depression severity, an average of 59% of patients with MDD report severe or very severe role impairment in at least 1 of the following domains: work, home, relationship, and social roles (AV 2).^{1… [Continue Reading]}

On the basis of a US Food and Drug Administration (FDA) approved clinical trial protocol, the study included 233 patients at 14 medical centers in the United States, 4 in Israel, 2 in Germany, and 1 in Canada.

All trial participants suffered from major depression and had previously failed to respond to therapeutic treatments or could not tolerate antidepressant medication owing to side effects.

Brainsway says it expects the study results will support its application for FDA approval to market its deep TMS system for the treatment of major depression in the United States.