By Jim Schutze
By Rachel Watts
By Lauren Drewes Daniels
By Anna Merlan
By Lee Escobedo
Everything was dark. Her eyes. Her clothes. The very core of her being.
The psychiatrist asked how she felt.
"That's the thing," said Lauri Sandoval, scrunching her face. "I don't feel."
That numbness. Sandoval knew its source: the depression that had been her life's shadow and had led to two suicide attempts, one at 20 when she downed pills from her mother's medicine cabinet and slit her wrists, the other in 1995 when she swallowed some tranquilizers with alcohol.
Now, her accomplishments, being a ballet dancer for 15 years, and later, an assistant to former Secretary of State James Baker, didn't matter. Her illness had dragged her down; her focus was shot, her fatigue heavy, and she had ballooned to a size 18, all because a common anti-depressant, Remeron, had fueled her appetite but done nothing to quash her illness. As for her two-year job as Baker's assistant, it ended badly. On one of his world missions, she put him on the wrong flight. He was kind about the misstep and simply said that mistakes like that couldn't happen. But she cried inconsolably in his presence. She still had a job, but she was slipping into a place so dark she didn't know if she could emerge. Soon, she quit her job and found the only work of which she was capable: cleaning dog cages and people's homes.
"Maybe," she continued, "if this device works for me and other people, it would be like being given a gift."
She was speaking of an experimental treatment, a mere 3-ounce device placed in the chest beneath the skin. The size of a small pocket watch, it sends electrical impulses to a crucial nerve in the neck. The vagus nerve, as it's called, is an information superhighway that goes to parts of the brain that control emotion, sleep, appetite, the very things that can be affected by depression. For a decade, the vagus nerve stimulation (VNS) device had been used to treat epilepsy, a condition for which the Food and Drug Administration approved its use in 1997. Along the way, scientists also noticed a curious side effect, that it lifted some patients' moods. The next step was to try it on those suffering from treatment-resistant depression, some of the one million people nationwide for whom a slew of medications, therapy, and, in some cases, electroconvulsive therapy, hadn't worked.
Sandoval was ready, hoping that the device could bring her the lasting peace that anti-depressants hadn't. "I'd love to feel joy," she said, tearing up. "Just to be able to feel that."
"You know that this is experimental," said her doctor of the device that some see as a brain pacemaker, a way to regulate mood as a mechanism might similarly manage the heart. "We don't know if it'll work or not."
Sandoval nodded. "It might work," she said, "but if it doesn't, I won't be worse off...knock on wood." She let out a nervous laugh.
"There's no wood here," Marangell said.
It's been about two years since Sandoval and 29 other people, about half from the Dallas area, joined doctors trying to answer one of the most pressing questions facing the world of psychiatry: Could the VNS device be a last-ditch hope for the chronically depressed and succeed when all other therapies had failed? There were four hospitals in the study, in New York, South Carolina, Houston, and at Dallas' University of Texas Southwestern Medical Center. That initial trial offered encouraging results; after 10 weeks, 40 percent of the patients showed a significant improvement in mood. Of that number, about 17 percent even said their depression was now totally gone.
Of the remaining 60 percent who saw no improvement, only two became worse, but that, as Southwestern's Dr. John Rush says, is only because of the nature of depression itself. "It waxes and wanes," he says, adding that no one attempted suicide or has since.
Of the success rate, Rush, who was chosen by the device's manufacturer, Cyberonics, to lead both studies, says: "We would have been excited if we would have gotten anything over 10 percent. It was surprising."
Now, doctors are seeking to determine if those results were merely a fluke or if they can be replicated. A second, larger trial, this time a controlled, double-blind study, is under way. About 210 patients, at both UT Southwestern and 19 other medical sites, are receiving implants, and as before, Rush is leading the entire study. "To my knowledge, it's the only device currently under investigation," he says, "and it's the only device that is being developed for depression. So it's pretty cutting-edge."
In the current study, half of all the patients' devices will be activated for 10 weeks while the remainder stays off. At a later point, the second group will have its devices activated, but the patients won't know when. "We're certainly very excited," says Dr. Mustafa Husain, a lead investigator of the trial at UT Southwestern, "but we want to approach it in an objective way. Our main interest is the safety of the patient."