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Clinical trials have demonstrated the effectiveness of NeuroStar® TMS Therapy in treating patients who have not benefited from prior antidepressant medication. NeuroStar TMS Therapy was studied in adult patients suffering from Major Depressive Disorder, all of whom had not received satisfactory improvement with previous treatments.
An Effective and Durable Option for Treating Major Depressive Disorder
In an independent, randomized, controlled trial funded by the National Institute of Mental Health, 307 patients were treated with the NeuroStar TMS System for 4 to 6 weeks, similar to real clinical context.1
Patients were divided into two groups:
Low Treatment Resistance: Patients who have failed to improve their depression symptoms after a single antidepressant treatment of adequate dose and duration.
High Treatment Resistance: Patients who have failed to improve their depression symptoms after a multiple (2-14) antidepressant treatments of adequate dose and duration.
At the end of their treatments, patients who had received NeuroStar 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 the NeuroStar TMS System also experienced significant improvement in anxiety and physical symptoms (such as appetite changes, aches and pains, and lack of energy) associated with depression.
Durability of TMS Treatments
NeuroStar TMS is the only TMS system with the durability of its effects established over 12 months.
In a trial with physician directed standard of care, meaning Neurostar 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.
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.
Additionally, Neuronetics has developed a new tool to use in educating patients on the best practices of treating depression. The Best Practices Treatment Guideline for Depression has been developed to help patients understand TMS Therapy as an option if their first line antidepressant medications stop working. This guideline is based on the 2010 American Psychiatric Association's practice guidelines and NeuroStar TMS Therapy indication for use, which says: NeuroStar 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.
Clinical trials have demonstrated the safety of NeuroStar TMS Therapy® in treating patients who have had an inadequate response to prior antidepressant medications.
Treatment with NeuroStar 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 NeuroStar TMS Therapy due to adverse events.
Over 10,000 active treatments were performed across all NeuroStar® clinical trials demonstrating its safety1
No systemic side effects
No weight gain
No sexual dysfunction
No dry mouth
No adverse effects on concentration or memory
No drug interactions
NeuroStar TMS Therapy should not be used in patients with implanted metallic devices or non-removable metallic objects in or around the head. This does not include metallic fillings in teeth.
NeuroStar TMS Therapy should not be used in patients with implants controlled by physiological signals. This includes pacemakers, implantable cardioverter defibrillators (ICDs), and vagus nerve stimulators (VNS).