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Study to Compare Use of Vagal Nerve Stimulator with Antidepressants

WINSTON-SALEM, N.C. – Wake Forest University Baptist Medical Center will participate in a national research study to observe the effects of vagal nerve stimulators and antidepressants in participants with treatment-resistant depression.

Wake Forest Baptist will be one of about 100 centers in the study, which will involve 1,000 people who have had a vagal nerve stimulator implanted for treatment-resistant depression and 1,000 participants who are on antidepressant drug therapy.

Similar to a pacemaker, a vagal nerve stimulator is a silver-dollar-sized device that is implanted under the skin near the collarbone. A wire lead under the skin connects the device to the vagus nerve in the neck. The battery-powered device produces weak electrical signals that travel along the vagus nerve to the brain at regular intervals.

Peter B. Rosenquist, M.D., associate professor of psychiatry and behavioral medicine, will be the principal investigator at Wake Forest Baptist, which will seek to enroll up to 24 participants.

The focus of the study is on those people who have major depression who have had an inadequate response to a series of four or more antidepressants, said Rosenquist. The study is aimed at observing what happens to these participants over the course of their current treatment. It will analyze response to treatment, quality of life, productivity and use of health care services.

“The objective is to follow the clinical course and outcome for participants with and without the addition of vagal nerve stimulation therapy,” said Rosenquist. “The ultimate goal is to improve treatment for those with severe and chronic depression who have not found relief with antidepressant medications.”

The vagal nerve stimulator participants will be followed for five years, as will one-third of the participants on antidepressants. The remaining participants will be followed for two years. If a participant enrolls in the antidepressant arm of the study and later decides to get vagal nerve stimulation therapy, the participant could remain in the study for an additional five years.

The national study is called the Treatment-Resistant Depression Registry and is being paid for by Cyberoncs, Inc. of Houston , Texas, which makes the vagal nerve stimulator.

According to the company, the registry is the first that involves treatment-resistant depression. Cyberonics said the registry would include data on symptoms of depression, response to treatments, women’s health issues, job-related activities, quality of life, sexual experience, suicide and suicidal thoughts, side effects, medical conditions and dosage and length of various antidepressants. Participant data will be kept confidential.

About one in six Americans will have a bout of depression over the course of a lifetime, and as many as one-third of those will have treatment-resistant depression.

For further information on the study, call 336-716-9234.

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Media Contacts: Robert Conn, rconn@wfubmc.edu, Karen Richardson, krchrdsn@wfubmc.edu, or Shannon Koontz, shkoontz@wfubmc.edu, at (336) 716-4587.

Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital and Wake Forest University Health Sciences, which operates the university’s School of Medicine. The system comprises 1,187 acute care, psychiatric, rehabilitation and long-term care beds and is consistently ranked as one of “America’s Best Hospitals” by U.S. News & World Report.

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