Fighting Depression

October 19, 2005 (WLS) -- An estimated four million adults are living with depression so serious it can't be treated with therapy or pills. But now an implanted device is offering hope.

Some epilepsy patients have been using VNS, or vagus nerve stimulation, for years to reduce seizures. But doctors also noticed an odd side effect; it seemed to improve mood. That launched studies of the device, and now the FDA has approved VNS for hard to treat depression. But some say it is risky.

Terri Cavin is once again savoring the sweetness of life. She loves spending time with her grandchildren and grown children. But, for two decades, her severe bouts with depression left her unable to function. She attempted suicide, was in and out of the hospital and many days couldn't get out of bed.

"I don't think there is a medication on the market that I haven't either been on by itself or in combination with others," said Cavin.

But nothing seemed to work. Her treatment resistant depression made her a candidate for the vagus nerve stimulator. This flat little machine is now planted in her chest.

Terri's family was a bit skeptical.

"It seemed a bit weird to me that a device could do something a medication couldn't," said Faith Poirier, daughter.

A thin wire connected to the tiny machine is wrapped around Terri's vagus nerve on the left side of her neck. Every five minutes the device sends an electrical charge up the wire through the nerve to stimulate Terri's brain. Exactly why it improves mood is unknown, but there are theories.

"When you stimulate the vagus nerve it actually releases a number of brain chemicals. Many of these are the brain chemicals we know are responsible for controlling mood and helping mood especially for people who may be depressed," said Dr. John Zajecka, psychiatrist, Rush University Medical Center.

Zajecka has been testing VNS therapy in clinical trials at Chicago's Rush University Medical Center. His studies and others showed that after having VNS for a year about 30 percent of the patients were less depressed. Researchers also say those effects are long term..

"For those people where other treatments have failed to work this is a real breakthrough," Zajecka said.

But not everyone in the medical community is embracing VNS.

The Food and Drug Administration approved the device for depression several months ago. Now, critics are questioning that approval. The consumer watchdog group Public Citizen says there is not enough science to prove it works or is safe.

"The main dangers that cropped up in clinical trials were sudden death, increase in suicidal thinking and worsening depression, all things you don't want to see in an implantable device or any device," said Dr. Peter Lurie, Public Citizen health research group. "The company has done a series of studies, and together, they are totally unconvincing. This device should not have been approved."

But a spokesman for Cyberonics says two years of clinical studies show the device works. And, of the more than 30,000 patients, including those with epilepsy who have been implanted with VNS therapy, there have been no serious adverse events directly related to the device.

Terri Cavin has been on the VNS therapy for about four years. She says she doesn't feel the slight electrical pulses and recently had an even smaller model of the device implanted at Rush North Shore Medical Center. Terri still takes medication, but coupled with the VNS, she says her depression is manageable. She is a believer and so is her family.

"I'm getting back to where I'm decorating cakes for some people and making candy and stuff, and it feels good.. it feels good," Cavin said.

The price tag for this treatment is $20,000 and insurance may not cover it. To reiterate, this surgery is only for patients who have tried four other depression therapies without success.

VNS is also being studied as a treatment for anxiety disorders, Alzheimer's, migraines and bulimia.

Rush North Shore Medical Center
847-677-9600
www.rnsmc.org

Rush University Med Center
312-942-5000
www.rush.edu

Evanston Hospital
847-570-2000
847-570-2000
www.enh.org

Vagus Nerve Stimulator
www.vagusnervestimulator.com

Cyberonics
www.cyberonics.com

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