FDA Clears Stimulation Device for Decreasing Anxiety Symptoms in Depressed Patients
September 7, 2021   

The BrainsWay Deep Transcranial Magnetic Stimulation (Deep TMS) System has received expanded labeling by the U.S. Food and Drug Administration (FDA), allowing marketing for the treatment of comorbid anxiety symptoms in major depressive disorder (MDD), also known as anxious depression. As part of the indication, patients must also have failed to achieve satisfactory improvement from antidepressant medication treatment in the current major depressive episode. The expanded depression indication is based on data from 11 studies (N=573) showing consistent and robust declines in anxiety symptoms in adult patients with MDD. Data from three randomized controlled trials demonstrated effect sizes (Cohen’s d) ranging from 0.34 (when compared to sham) to 0.90 (when compared to medication), and an overall weighted, pooled effect size of 0.55. By contrast, effect sizes for drug-based anxiety treatments range from 0.2 to 0.37 when prescribed to patients suffering from anxious depression and general anxiety disorder.

>> BrainsWay Press Release

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