Researchers at the University of Nebraska Medical Center Department
of Psychiatry are involved in a nationwide study that could become the
first new treatment for depression in 50 years. Out of more than 100 sites
that applied to participate in the study, UNMC was one of 20 centers selected
to test the safety and effectiveness of an implantable device.
UNMC has received a $275,000 grant from Cyberonics, Inc., to conduct
a 12-week study that will test the companys NeuroCybernetic Prosthesis
system, an implantable device similar to a cardiac pacemaker. The device
is a stopwatch-sized generator implanted in the chest with a nerve stimulation
electrode attached to the vagus nerve in the neck. It delivers preprogrammable,
intermittent electrical pulses 24 hours a day.
The device will be studied for its effectiveness in people with moderate
to severe depression who have not responded to other treatments. Current
treatments options for depression include anti-depressant drugs, psychotherapy,
and electroconvulsive therapy.
UNMC is seeking from 10 to 30 patients age 19 to 65 with recurring,
severe to moderate depression who have failed to respond to conventional
treatment. About 200 patients will be enrolled nationwide.
This may give people with severe depression another option, said William
Burke, M.D., professor and director of the UNMC Psychopharmacology Research
Center. We have good therapy for probably 90 percent of people with depression
but there have been a group of about 10 percent who have more persistent
depression that does not respond to treatment.
We are encouraged by the results from the pilot study. Forty percent
of the 30 patients in an initial study met criteria for having recovered
from their depression. That is pretty amazing given the average length
of time that those persons had been depressed was more than 10 years. Rates
of relapse have also been low in those who recovered, which is also impressive
given that relapse for this type of depression is not unusual.
He said no one knows for sure how the device helps treat depression.
The theory is that the vagus nerve, which sends signals up to the part
of the brain that controls sleep, appetite and energy, may work like many
of the drugs we use as antidepressants. This device may deliver a more
direct electrical stimulation to those parts of the brain that weve been
trying to stimulate with medicine.
The device, not yet approved for treating depression in the U.S., was
approved in 1994 in Europe and 1997 in the U.S. for the treatment of epilepsy
and has been used over 10,000 patients with epilepsy.
Chosen to participate in the study to date are: UNMC, the University
of Minnesota; University of Miami, Saint Louis University; Medical University
of South Carolina in Charleston; Baylor College of Medicine in Houston;
Stanford University, Brown University/Butler Hospital, Via Christi Psychiatric
Research Institute in Kansas City; SUNY Upstate Medical University at Syracuse
and Emory University in Atlanta.
The reason the device is even being tested in depression is that when
the device has been used in epilepsy, neurologists reported that it was
having positive effect on peoples mood and their sense of well-being even
if it didnt reduce the number of seizures.
Patients will be screened for eligibility in the study. Patients accepted
into the study will have the device implanted free by UNMC surgeons, Drs.
Dan and Bill Lydiatt, followed by an estimated two-week recovery period.
Implanting the device typically takes one to two hours in an outpatient
basis. During the 12-week controlled study following surgical recovery,
half of the patients devices will be turned on while the other half will
be turned off. During that time patients will remain on whatever
medications they had been taking.
Dr. Burke said most people in the study wont be aware the device is
on. After the 12-week controlled study, all devices will be tuned on and
treatment will continue with periodic visits. There are no costs to persons
participating in the study.
Depression is one of the most painful human conditions, Dr. Burke
said. Depression causes low mood, lack of interest, makes it very hard
to get things done, and can deprive people of any sense of pleasure. They
may have problems sleeping, poor appetite, low energy, and may walk around
in a fog. They may think life isnt worth living and consider suicide
as a way out. Its a horrible condition to live with.
It is telling that the primary concern of the people weve talked to
so far has been whether this will help their depression my expectation
was that they would be far more focused on the surgical procedure, Dr.
Burke said. Theyve been depressed for so long and feel so lousy that
their focus is simply finding something to help them.
For more information about the study, call UNMC at (402) 559-5056. Information
about the device and study also can be found at www.cyberonics.com.
Cyberonics, Inc. was founded in 1987 to design, develop and market medical
devices for the treatment of epilepsy and other debilitating disorders
using a unique therapy, vagus nerve stimulation. The company’s initial
target market is epilepsy, the world’s second most prevalent neurological
disorder, which is characterized by recurrent seizures.
UNMC is the only public academic health science center in the state.
Its educational programs are responsible for training more health professionals
practicing in Nebraska than any other institution. Through its commitment
to research, education, outreach and patient care, UNMC has established
itself as one of the country’s leading centers for research in cancer,
genetics, cardiovascular diseases, neurodegenerative diseases and arthritis.
During the past year, UNMCs research funding increased by 31 percent and
now exceeds $40 million, including more than $25 million in federal funding
from such sources as the National Institutes of Health, the National Science
Foundation, Department of Defense and Veterans Administration.