It's estimated in the U.S. that nearly 15 million people experience a depressive disorder every year and that nearly 17% of adults in the U.S. will experience major depression in their lifetime. And in that number, research has shown that many patients looking to treat their depression won't respond adequately to the first antidepressant treatment they are prescribed.

So finding the right kind of treatment for major depressive disorders is often challenging for patients and doctors alike, but a new application by Aspect Medical (Norwood, Massachusetts) might help eliminate some of the difficulties.

Results from the clinical study Biomarkers for Rapid Identification of Treatment Effectiveness Trial in Major Depression (BRITE), show that Aspect's EEG-based Antidepressant Treatment Response indicator, is a significant predictor of patient response and remission after one week of treatment with the commonly prescribed antidepressant escitalopram. The company suggests that ATR has the potential to positively impact depression treatment outcomes by helping clinicians select the most effective antidepressant for each patient early in their treatment.

The BRITE trial was conducted in collaboration with investigators from nine facilities throughout the country and saw 375 patients. Their response was defined by researchers as a 50% improvement in depression symptoms as measured by the Hamilton Depression Rating Scale after seven weeks of treatment, and remission was defined as recovery from depression after seven weeks of treatment.

In the study, ATR at one week predicted the response and remission with 74% accuracy in subjects treated for seven weeks with escitalopram, which was statistically significant. These results were then published in the September issue of the journal Psychiatry Research.

"The results of the trial have been reported in various scientific sessions, but this is the first peer-review publication of these results," Amy Siegel VP of Strategic Marketing for Aspect Medical told Medical Device Daily. "This is pretty significant."

ATR works by using six sensors to measure electrical activity in the brain and translate it into a number between 0 and 100. Two of the sensors are placed on the ears and the rest are placed along the head. The sensors hook up to a laptop which measures the EEG. The test can be taken in an office setting within 10 to 15 minutes.

Patients first get readings prior to taking medication, then another about a week after the anti-depressant medicine is administered.

The lower the score, derived from the ATR index the least likely a patient is to respond to the treatment.

"You don't know how someone is going to respond to treatments," Andrew Leuchter, MD a professor of Psychiatry at the Semel Institute for Neuroscience and Human Behavior at University of California Los Angeles, principal investigator for the trial, and chair of Aspect's Neuroscience Advisory Board told MDD. "What ATR does is lets us see within one week if patients are going to respond to the therapy or not."

Leuchter, who helped develop the device at UCLA back in 2002 added that, while using ATR on patients doesn't predict the right dose of medication, it does give info on if the right medication is being used to treat the illness.

"BRITE study results suggest that ATR could potentially provide the greatest clinical benefit for those patients who might be receiving a medication that is unlikely to help them. Our results suggest that it may be possible to switch these patients to a more effective treatment quickly. This would help patients and their physicians avoid the frustration, risk and expense of long and ineffective medication trials," said Leuchter. "Research has shown that depression patients who do not get better with a first treatment attempt experience prolonged suffering, are more likely to abandon treatment altogether from lack of efficacy and may become more resistant to treatment over time."

In the future, the company plans to continue the ATR research effort and conduct a multi-year follow-on study of ATR called the PRISE-MD study (Personalized Response Indicators of SSRI Effectiveness in Major Depression). This study will is expected to prospectively evaluate the ability of ATR to predict response to escitalopram as well as the clinical utility of ATR-directed treatment with escitalopram or an alternate treatment with bupropion. Funding for this study comes from a grant from the National Institutes of Health.

Phillip Devlin, VP of Emerging Tech at Aspect said that the company is currently in talks with the FDA to decide what regulatory path it would proceed down to obtain market clearance of ARS, but stopped short of saying what that clearance might be.

"This is very promising research," Devlin touted.

Based on the findings, the company said it would be realistic to expect to see the device commercialized in the next five years.

Omar Ford, 404-262-5546;