Contact: Ellen Bank
843.792.2626
Sept. 13, 2005
MUSC Investigators Participated in Study Which Shows 42 Percent Response and 22 Percent Remission Rates Seen After Two Years of Adjunctive VNS
Two-year results from a peer-reviewed study using vagus nerve stimulation (VNS) for treatment-resistant depression were published in the September 2005 issue of the Journal of Clinical Psychiatry (J. Clin Psychiatry 66:9, September 2005).
The article, entitled "Two-Year Outcome of Vagus Nerve Stimulation (VNS) for Treatment of Major Depressive Episodes," by MUSC's Ziad Nahas, M.D., and Mark S. George, M.D., et. al. presents the three-month, one-year and two-year response and remission rates from the 60-patient VNS pilot study conducted at Medical University of South Carolina (MUSC), Baylor College of Medicine, University of Texas Southwestern Medical Center and Columbia University. Based on last observation carried forward analyses, response rates were 42 percent and remission rates were 22 percent after two years of adjunctive VNS Therapy TM in patients that had received a mean of 15.7 unsuccessful clinical treatments in the current depressive episode, the median of which was 6.8 years. At two years, 81 percent of the study participants were still receiving VNS Therapy.
Nahas is medical director of the Brain Stimulation Lab and director of the Mood Disorder Program at MUSC, and George is distinguished professor of psychiatry, radiology and neurosciences at the Medical University of South Carolina
"The two-year results from the pilot study for VNS Therapy found short-term and long-term benefits for more than one-third of treatment-resistant depression patients in the trial. Benefits seen at one year were largely sustained for the group at two years, and one of two initial responders continued to evidence response after two years," commented George, who oversaw the first VNS implant for depression at MUSC in 1998. "These long-term data on these initial patients are part of a growing body of peer-reviewed literature further confirming the significant relationship between VNS Therapy and long-term improvements in overall presence of depression and its symptoms. VNS Therapy's availability for treatment-resistant depression patients provides a new option to try when first-line treatments are unable to provide relief from chronic depression."
The publication of peer-reviewed data follows FDA approval of VNS Therapy as an adjunctive long-term treatment of chronic or recurrent depression for patients 18 years of age or older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.
VNS Therapy is the first implantable device-based treatment for depression and the first treatment specifically developed, studied, approved and labeled for treatment-resistant depression. In addition to treatment-resistant depression and pharmacoresistant epilepsy indications, VNS Therapy is at various stages of investigational clinical studies as a potential treatment for anxiety disorders, Alzheimer's disease, bulimia and chronic headache/migraine.
The VNS Therapy System was approved by the FDA on July 15, 2005 "as an adjunctive long-term treatment for chronic or recurrent depression for patients 18 years of age and older who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments." The VNS Therapy System has been approved for sale in the European Economic Area and in Canada as a treatment for depression in patients with treatment-resistant or treatment-intolerant major depressive episodes, including unipolar depression and bipolar disorder (manic depression) since 2001.
#####