Honolulu, Hawaii — Results of a Neuronetics-sponsored, multisite observational study of patients with major depressive disorder (MDD) treated with Neuronetics' NeuroStar Transcranial Magnetic Stimulation (TMS) Therapy in clinical practice showed outcome and adherence rates that were consistent with those observed in patients treated in controlled clinical trial settings.
Approved by the
FDA in October 2008, NeuroStar TMS Therapy is a non-systemic (does not circulate in the bloodstream throughout the body) and non-invasive (does not involve surgery) form of neuromodulation. It stimulates nerve cells in an area of the brain that has been linked to depression by delivering highly focused MRI-strength magnetic field pulses. Treatment is typically administered daily for four to six weeks. Last month, Neuronetics reported that a study of patients with MDD who were treated with TMS Therapy exhibited
no negative effects in cognitive function after six-month follow-up. In the new study, 99 patients with a primary diagnosis of MDD and who had previously been treated with antidepressant medications without benefit were evaluated. The study was conducted in 40 clinical practices in the United States and the findings were presented this week at the American Psychiatric Association meeting in Honolulu, Hawaii.
"In conjunction with data from randomized controlled clinical trials, information obtained from observational studies of patients treated in real world settings provides an important perspective on how research-based findings translate to treatment in clinical practice," said Mark A. Demitrack, MD, Chief Medical Officer at Neuronetics.
"There are few studies that have examined the effectiveness of TMS Therapy in a large sample of patients across multiple real world practice settings, and we are pleased that the results validate the data of prior controlled studies and support the use of NeuroStar TMS as an effective treatment for patients who have failed to receive benefit from initial antidepressant medication."
In the overall study population, as measured by the Inventory of Depressive Symptoms Self-Report scale (IDS-SR) criteria, 53.6 percent—or one in two patients—achieved response and 35.1 percent—or one in three patients—achieved remission by the end of acute treatment. Similarly, using the Patient Health Questionnaire Nine item scale (PHQ-9), 66.7 percent—or two in three patients—reported no or only mild depression scores (a PHQ-9 total score of less than 10) at the end of acute treatment.
Similar to these patient-rated outcomes, forty-four percent of patients—or nearly one in two—achieved a final score of one (normal, not at all ill) or two (borderline ill) out of seven (extremely ill) using the physician-rated Clinician Global Impressions Severity of Illness scale (CGI-S).
Thus, patient self-report measures were consistent with physician observation.
"These data add to the impressive body of evidence that support the positive impact that TMS Therapy may have on patients living with major depression," said Karl Lanocha, MD, Medical Director of The TMS Center of New England.
Patients with a primary diagnosis of MDD, who had failed to receive adequate benefit from prior antidepressant medication, sought acute treatment with NeuroStar TMS Therapy in a clinical practice.
NeuroStar TMS was provided as clinically determined by the evaluating physician and outcome assessments were performed prior to initiation of the first TMS treatment; at two weeks after treatment began; at the point at which the physician determined that maximal acute treatment had been reached; and, at six weeks if the final acute treatment was longer than six weeks. Assessments included the CGI-S, the PHQ-9, and the IDS-SR.
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