NEW YORK, May 5, 2014 - Neuronetics, Inc. announced today results from a new, dual-arm randomized pilot study that showed a trend toward symptomatic improvements with once-monthly TMS maintenance therapy in medication-free patients treated with NeuroStar TMS Therapy® for Major Depressive Disorder (MDD). Six weeks of acute NeuroStar TMS Therapy induced remission in 61.2 percent of all enrolled patients. At three months, 62.5 percent of medication-free patients randomized to once-monthly treatment with NeuroStar TMS Therapy maintained response as compared to 43.8 percent of patients who did not receive maintenance treatment. The complete findings will be presented at the 167th American Psychiatric Association Annual Meeting in New York City.
"This pilot study supports the notion that maintenance TMS may be useful in the prevention of recurrence of major depression and is an important step in learning what the optimum treatment parameters will be," said Scott Aaronson, M.D., Director of Clinical Research Programs, and Associate Medical Director at Sheppard Pratt. "This preliminary information will help define an approach to TMS as a maintenance therapy as we extend our understanding of the long-term usefulness of TMS in the treatment of people with this debilitating illness."
In the study, medication-free patients with a diagnosis of unipolar, non-psychotic MDD, who had failed to receive benefit from prior antidepressant medication were treated with 6 weeks of NeuroStar TMS Therapy; patients who met response criteria were randomized to either once monthly maintenance TMS treatments or monthly observation. Patients in either cohort could receive TMS reintroduction for protocol-defined symptomatic worsening. The primary outcome was the proportion of patients without symptomatic worsening throughout the three months of the maintenance treatment phase.
"As evidenced by this first pharmacotherapy-free maintenance trial, Neuronetics is committed to investing in continued research efforts that provide validation of NeuroStar TMS Therapy, and which may help better our understanding of depression and improve patients' therapeutic outcomes," said David Brock, M.D, Medical Director at Neuronetics.