New York-Presbyterian Hospital/Columbia University Medical Center is the first in the greater New York City-area to offer Vagus Nerve Stimulation (VNS) Therapy as a long-term treatment specifically approved by the FDA for treatment-resistant depression (TRD).
VNS Therapy is approved as a long-term adjunctive (add-on) treatment 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. VNS Therapy was approved for the treatment of drug-resistant epilepsy in 1997, and is now the first treatment specifically studied and approved for TRD. Major depressive disorder is one of the most prevalent and serious illnesses in the U.S., affecting nearly 19 million Americans every year. Of those, one fifth, or approximately four million people, do not respond to multiple antidepressant treatments. For these people, psychotherapy, antidepressant medications, and even sometimes electroconvulsive therapy do not work, or only work for a short while and stop working over time. VNS Therapy is a newly approved treatment option for these people.
"Patients with treatment-resistant depression need safe and effective therapeutic options. The availability of an FDA-approved treatment for the long-term management of depression is an important development for the disturbingly large number of people with depression who have not responded to other approved treatment options," says Dr. Sarah H. Lisanby, director of the Columbia Brain Stimulation Service at NewYork-Presbyterian/Columbia and associate professor of clinical psychiatry at Columbia University College of Physicians and Surgeons. She is also director of the Brain Stimulation and Neuromodulation Division, director of the Brain Behavior Clinic, and research scientist in the Department of Neuroscience at the New York State Psychiatric Institute.
"Open studies suggest that the benefits from VNS were sustained over time, and that VNS was very tolerable with few side effects," continues Dr. Lisanby.
Early clinical research of VNS Therapy for TRD was conducted at study sites, including NewYork-Presbyterian/Columbia, beginning in 2001. Recent studies have found that half of patients with an average of 25 years of major depressive disorder and multiple treatment trials realized some clinical benefit; one-third of patients had at least a 50 percent improvement in their depression; and one out of six was depression-free after treatment with VNS Therapy. Patients also reported significant improvements in quality-of-life areas, such as vitality, mental health, emotional well-being, and social functioning.
"VNS Therapy is delivered from a small pacemaker-like device implanted in the chest area that sends mild pulses to the brain via the vagus nerve in the neck. A thin, insulated wire, attached to the generator, runs under the skin to the left vagus nerve," says Dr. Guy M. McKhann II, Florence Irving Assistant Professor of Neurological Surgery at Columbia University College of Physicians and Surgeons and assistant attending neurosurgeon at NewYork-Presbyterian/Columbia University Medical Center. The vagus nerve, one of the 12 cranial nerves, serves as the body's "information highway" connecting the brain to many major organs. Several studies have shown that VNS Therapy may modulate neurotransmitters such as serotonin and norepinephrine thought to be involved in mood regulation.
Cyberonics, Inc., of Houston, manufactures the VNS Therapy System.