The iconic symbol of the psychiatrist’s office–the psychoanalyst’s couch–could soon be supplemented with new medical devices that can help doctors treat patients or objectively assess how treatment is progressing. Two experimental devices–one to treat patients with drug-resistant depression, and one that can quickly assess if a particular medication is working–are currently in late-stage clinical development. They could transform psychiatry from a specialty practiced largely with a prescription pad into one that more closely resembles a typical medical specialty.
“Psychiatrists don’t do procedures; they do talk therapy and write scripts,” says Mark Bausinger, chief financial officer of Neuronetics, a medical-device company based in Malvern, PA, that is developing a noninvasive treatment device. “So this is really going to change the way they work.”
While antidepressants such as Prozac and Lexapro have been a huge boon to the treatment of depression, they possess some serious limitations. Antidepressants can take weeks or months to exert their full benefit, and different patients respond to different drugs. Because doctors have no way to predict the best drug for a particular patient, many people spend months or even years switching or tweaking their prescriptions to find the drug or combination best suited to them. In addition, recent studies have shown that about a third of patients do not respond to any medication they try, leaving them with options such as electroconvulsive therapy (ECT), which is effective but carries serious side effects.
A new device that measures brain waves could help solve the first problem. While it may take patients several weeks of medication to feel better, previous research has shown that brain-activity changes measured via electroencephalogram (EEG) can, within just one week, predict if that medicine will help. Patients who are likely to improve show a decrease in activity in certain parts of the brain.
In 2001, Aspect Medical Systems, a neurotechnology company based in Norwood, MA, began developing a commercial version of this EEG technology. Requiring only five electrodes to be placed on a subject’s forehead and temples, rather than 20 or more electrodes scattered over the entire scalp, the device is much easier to use than the EEG systems typically employed in research labs.
The company is now sponsoring a large, multicenter clinical trial to determine if the device can reliably detect antidepressant response. Initial results from the study, presented this week in San Diego at a meeting of the American Psychiatric Association, are promising. After a week of treatment, the device could predict if a particular drug would work in the longer term 70 to 80 percent of the time.
“Psychiatry is the last specialty without a good diagnostic test to guide treatment,” says Andrew Leuchter, a researcher and psychiatrist at the University of California, Los Angeles, and a study leader. “I think there is a lot of enthusiasm for a quick test that can be carried out in the doctor’s office and inform treatment.” Leuchter’s group did some of the early research underlying the device, and he heads Aspect’s science advisory board.
Aspect expects to finish the trial of more than 300 patients this year and is in talks with the Food and Drug Administration (FDA) about requirements for regulatory approval. The company eventually aims to market the device to psychiatrists. “Many patients will abandon their medications if they do not feel sufficient improvement in the first few weeks,” says Maurizio Fava, a psychiatrist at Harvard Medical School and Massachusetts General Hospital, in Boston. “So having a reliable prediction will help patients stay on track.”
A second device, developed by Neuronetics, could provide an alternative treatment for patients for whom drugs do not work. Known as NeuroStar, the device delivers short magnetic pulses to the part of the brain involved in mood. Delivered via a noninvasive wand attached to the head, the pulses travel through the skull to the cortex, activating brain cells in the target area. “This is the first truly novel outpatient treatment for decades,” says Bausinger, chief financial officer at Neuronetics.
The company sponsored a 325-person multisite trial of the device, which concluded last year. After six weeks of treatment for several hours a week, about 40 percent of patients reported a reduction in their symptoms of 50 percent or more. Fourteen percent were in remission, meaning they no longer qualified as being depressed, compared with 6 percent of the placebo group. While the remission rate may seem low, psychiatrists say this is a significant improvement for such a difficult to treat population. The study found no cognitive side effects, and the device is now under review by the FDA. Neuronetics also plans to market its device to psychiatrists.
The treatment is lengthy: patients in the trial underwent five sessions per week for four to six weeks. “I think people who failed a couple of trials of antidepressants will take the time to do it because they are suffering,” says Brent Solvason, a psychiatrist at Stanford University, in California, who led the trial. And it is likely to be more appealing to severely depressed patients than electroconvulsive therapy, which is effective but can trigger memory loss, or vagus nerve stimulation, which requires surgery.
Both devices are designed to be easy to use–so easy, in fact, that a nurse or technician, rather than a psychiatrist, might perform the procedure. Perhaps someday, a visit to the psychiatrist’s office will resemble a trip to the dentist’s or physical therapist’s office, where a mental hygienist, rather than a dental hygienist, will work on your brain before the doctor comes in to render his final opinion.
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