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.