Neuronetics, Inc., announced that results of a study designed to assess the long-term effectiveness of NeuroStar TMS Therapy in adult patients with Major Depressive Disorder (MDD) who have failed to benefit from prior treatment with antidepressant medications.
The study got published online in The Journal of Clinical Psychiatry
. The study found that TMS treatment with the NeuroStar TMS Therapy System induced statistically and clinically meaningful response and remission in patients with treatment resistant MDD during the acute phase of therapy, which were maintained through one year of follow-up. At the end of acute treatment, 62 percent of patients achieved symptomatic improvement while 41 percent reported complete remission. At 12 months, 68 percent of patients achieved symptomatic improvement while 45 percent reported complete remission. Maintenance of benefit was observed under a pragmatic regimen of continued antidepressant medication and TMS reintroduction for symptom recurrence.
"The durability of NeuroStar TMS Therapy demonstrated by this robust, real-world study is remarkable, as it's not typical to see durability of long-term benefit in patients who have treatment resistant forms of depression," said Dr. David Dunner, M.D., Director of the Center for Anxiety and Depression in Mercer Island, WA, and Professor Emeritus at the University of Washington in Seattle. "The publication of these findings is an important validation for the sustained efficacy of NeuroStar TMS Therapy in a majority of patients with depression who have not found relief through antidepressant medication."
With 42 clinical practices participating, 307 patients with a primary diagnosis of unipolar, non-psychotic major depressive disorder and who had failed to receive benefit from prior antidepressant medication, received NeuroStar TMS Therapy.
The objectives of this study were to assess the change in depressive symptomatology and functional capacities across the duration of acute and long-term follow-up treatment with NeuroStar TMS. Of the patient population, 257 patients completed their acute TMS treatment, then were tapered from their acute treatment regimen and consented to long-term observation over 52 weeks.
Clinical assessments were based on data obtained at three, six, nine and twelve months using the clinician-rated Clinical Global Impression Severity of Illness (CGI-S), and the patient-rated Patient Health Questionnaire (PHQ-9) and Inventory for Depressive Symptomatology-Self Report (IDS-SR).
Neuronetics, Inc. is building upon the robust clinical evidence base for the use of NeuroStar TMS Therapy in patients with depression. Most recently, Neuronetics initiated an open-label study to evaluate the safety and efficacy of NeuroStar in patients with MDD who are suffering from post-partum depression. Neuronetics also completed a 12-month randomized study on the utility of TMS as maintenance therapy.