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Clinical trials have demonstrated the safety of TMS Therapy in treating patients who have had an inadequate response to prior antidepressant medications.
Treatment with TMS Therapy caused very few side effects and was generally well tolerated by patients. The most common side effect reported during clinical trials was scalp discomfort—generally mild to moderate and occurring less frequently after the first week of treatment.
Fewer than 5% of patients discontinued treatment with TMS Therapy due to adverse events.
Over 10,000 active treatments were performed across all clinical trials demonstrating its safety1
Clinical trials have demonstrated the effectiveness of TMS Therapy in treating patients who have not benefited from prior antidepressant medication. TMS Therapy was studied in adult patients suffering from Major Depressive Disorder, all of whom had not received satisfactory improvement with previous treatments.
In an independent, randomized, controlled trial funded by the National Institute of Mental Health, 307 patients were treated with the TMS Therapy for 4 to 6 weeks, similar to real clinical context.1
Patients were divided into two groups:
At the end of their treatments, patients who had received TMS Therapy were four times more likely to achieve remission compared to patients receiving a sham treatment. 1 in 2 patients experienced significant improvement in their depression symptoms and 1 in 3 experienced complete remission. Patients treated with TMS Therapy also experienced significant improvement in anxiety and physical symptoms (such as appetite changes, aches and pains, and lack of energy) associated with depression.1
In a trial with physician directed standard of care, meaning TMS Therapy could be used in conjunction with antidepressants as needed, patients who had received treatment then reported their symptom levels at 3, 6, 9 and 12 months to determine the durability of their treatments. By the end of the 12-month period, 2 out of 3 patients who had either responded or completely remitted after TMS treatment remained at the symptom levels they reported at the end of the treatment phase.1
After the end of the treatment period, only 1 in 3 patients needed to come back for maintenance TMS sessions, or ‘reintroduction’ during this 12-month period.1
This guideline is based on the 2010 American Psychiatric Association’s practice guidelines and TMS Therapy indication for use, which says:
TMS Therapy is indicated for the treatment of major depressive disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication at or above the minimal effective dose and duration in the current episode.
TMS Therapy has not been studied in patients who have not received prior antidepressant treatment.