Investigational device-based therapies will lead to entirely new treatment options for chronic depression sufferers as early as late 2006, according to an American Psychiatric Association symposium to be presented this week on treatment-resistant depression.
Researchers said that developing brain stimulation techniques such as transcranial magnetic stimulation (TMS), vagal nerve stimulation and deep brain stimulation are emerging as significant treatment options for the millions of patients "poorly served" by existing therapies. Of the 14 million U.S. adults who suffer from a major depressive disorder each year, 7.2 million receive treatment, of which 4 million get little to no relief from existing therapies or are unable to tolerate antidepressant drugs.
"Despite major advances in disease awareness, delivery of care, and safer, more tolerable pharmacologic options, the effectiveness of drug therapy for major depression is fundamentally no better than it was two decades ago," said Dr. Mark A. Demitrack, Vice President and Chief Medical Officer of Neuronetics, Inc. and chairman of the symposium in a presentation entitled, "Difficult to Treat Depression: Better Choices, Better Outcomes."
"Because the social, economic, medical and personal consequences of depression are substantial, the need for clinical study of effective new treatments such as neurostimulation is urgent."
Demitrack called for a "more effective paradigm" for treatment-resistant depression, incorporating a more balanced selection of treatment options, such as neurostimulation. One such therapy, TMS, produces pulses of magnetic energy that are directly targeted at the part of the brain believed to control mood, with the goal of improving the function of these key brain pathways. A clinical trial is currently underway nationwide to provide data in support of a regulatory application to the U.S. Food and Drug Administration (FDA) for marketing clearance of the Neuronetics TMS System for the treatment of depression.
"If it is proven effective, TMS would be an innovative and non-invasive therapeutic option, especially for people who have struggled with existing therapies," said Demitrack. "The safety of TMS is well documented in the clinical literature. If the results of the current study show positive antidepressant effects, and if the U.S. FDA clears the TMS technology for marketing, physicians will have an entirely new tool to combat major depression." The company anticipates seeking FDA approval in 2006.
Demitrack will make his remarks as part of a symposium entitled "Difficult Depression: Looking for Our Keys Beyond the Light We Can See." Other presentations will focus on the study of difficult depression as well as new antidepressant treatments.