Clinical trials have demonstrated the effectiveness of NeuroStar Advanced Therapy TMS in treating patients who have not benefited from prior antidepressant medication. NeuroStar Advanced Therapy TMS 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 NeuroStar Advanced Therapy TMS 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 NeuroStar Advanced Therapy TMS 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 NeuroStar Advanced 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
NeuroStar 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 Advanced 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
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 Advanced 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.
Please see the Treatment Algorithm for an effective illustration of the use of NeuroStar Advanced Therapy TMS early on in the treatment of depression.
NeuroStar Advanced Therapy has not been studied in patients who have not received prior antidepressant treatment.
TMS+YOU is an online community and national patient advocacy site for TMS Therapy. Those considering Transcranial Magnetic Stimulation can connect with patients who have had the treatment to answer questions, share insights, and get the latest information.
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Adult Indications for Use
The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode.
The NeuroStar Advanced Therapy System is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
Adolescent Indications for Use
NeuroStar Advanced Therapy is indicated as an adjunct for the treatment of Major Depressive Disorder (MDD) in adolescent patients (15-21). NeuroStar Advanced Therapy is only available by prescription. A doctor can help decide if NeuroStar Advanced Therapy is right for you. Patients’ results may vary.
Important Safety Information
The most common side effect is pain or discomfort at or near the treatment site. These events are transient; they occur during the TMS treatment course and do not occur for most patients after the first week of treatment. There is a rare risk of seizure associated with the use of TMS therapy (<0.1% per patient).
NeuroStar Advanced Therapy should not be used with patients who have non-removable conductive metal in or near the head. NeuroStar Advanced Therapy has not been studied in patients who have not received prior antidepressant treatment.