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Journal publishes results from
depression study
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 MUSC, Baylor College of
Medicine, University of Texas Southwestern Medical Center and Columbia
University. Based on the last observation carried forward analyses,
response rates were 42 percent and remission rates were 22 percent
after two years of adjunctive VNS therapy 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, and George is a MUSC
distinguished professor of psychiatry, radiology and neurosciences.
“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,”
said 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 “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.
Friday, Sept. 30, 2005
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