Upstate News

April 10, 2001
Doretta Royer 315 464-4833

SUNY Upstate to participate in national depression study

A therapy proven successful in controlling epilepsy is being tested at SUNY Upstate Medical University as a possible breakthrough therapy for treatment-resistant depression.

SUNY Upstate is one of 20 sites nationwide to participate in this Food and Drug Administration-approved three-year study of vagus nerve stimulation as a treatment for depression. The study is funded by Cyberonics Inc.

Vagus nerve stimulation (VNS) involves mild electrical pulses that are given to the vagus nerve in the neck that are in turn believed to regulate the function or activities of chemicals used by brain cells to communicate. VNS therapy is delivered by the Cyberonics’ NeuroCybernetic Prosthesis (NCP) System, an implantable medical device similar to a cardiac pacemaker.

A stopwatch-sized generator is implanted in the left chest and a nerve stimulation electrode is attached to the vagus nerve in the neck in a one hour procedure typically performed on an outpatient basis. Using an external programmer, the physician can set or reset the stimulation parameters of the device. The system continually delivers preprogrammed intermittent electrical pulses to the vagus nerve.

In order to determine the placebo effect, individuals are randomly assigned to control or treatment groups. However, ultimately all volunteers who participate in this study will have the opportunity for treatment.

“Our research volunteers represent a very select group of individuals who are moderately to severely depressed and who have failed medications and/or electroconvulsive therapy (ECT),” ” said the study’s principal investigator, Thomas Schwartz, M.D., assistant professor of psychiatry at SUNY Upstate. They will help us determine the degree and timing of antidepressant effects, and the safety and tolerability of VNS.”

The FDA approved VNS using the NCP System as a therapy for epilepsy in 1997. A year later, SUNY Upstate Medical University began using VNS therapy on patients with treatment resistant epilepsy. Since then, eighty patients have received the implant and therapy. Ten percent of these individuals are completely seizure-free; nearly everyone realized some decrease in seizures.

Depression, a mood disorder characterized by persistent, emotional disturbances in the normal cognitive functions of the brain, is an expensive and life-threatening disorder costing the United States an estimated $40 billion a year in lost work and healthcare costs. It is expected to be the second leading cause of disease burden in 2020.

Previous mood studies conducted at the University of Texas Southwestern Medical Center, the Medical University of South Carolina, the Columbia College of Physicians and Surgeons and Baylor College of Medicine, indicate that the use of VNS therapy is viable in controlling depression in people who are treatment-resistant, Schwartz said.

Cyberonics Inc. was founded in 1987 to develop medical devices for the treatment of epilepsy and other debilitating neurological disorders. To learn more about the study, visit the Cyberonics web site at www.cyberonics.com/depression or call 315-464-5631. Patients who are interested in the study may also call Cyberonics’ toll-free telephone number, 888-748-1652.

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