Results from the BRITE-MD trials published in Psychiatry Research: Aspect Medical Systems

Sep 11 2009

Aspect Medical Systems, Inc. (NASDAQ: ASPM) today announced that two companion articles highlighting results from the BRITE-MD (Biomarkers for Rapid Identification of Treatment Effectiveness trial in Major Depression) were published in the September issue of the journal Psychiatry Research. The BRITE trial results demonstrate that Aspect’s EEG-based Antidepressant Treatment Response (ATR) indicator is a significant predictor of patient response and remission after one week of treatment with the commonly prescribed antidepressant escitalopram. Retrospective analysis of BRITE data also 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 publication of BRITE trial results is a major milestone in our efforts to develop clinically useful biomarkers for predicting treatment response in Major Depressive Disorder. The BRITE results demonstrate that early changes in frontal EEG may help predict treatment outcome in as short a time as one week after the start of medication. We are hopeful that these results will be replicated by other researchers, and that an EEG biomarker can be used to help clinicians improve the care of patients suffering from depression,” said Andrew Leuchter, M.D., professor of Psychiatry at the Semel Institute for Neuroscience and Human Behavior at UCLA, principal investigator for the trial, and chair of Aspect’s Neuroscience Advisory Board.

The BRITE trial was conducted in collaboration with leading investigators from nine facilities across the United States and enrolled 375 patients. Patient response was defined by researchers as a 50 percent improvement in depression symptoms as measured by the Hamilton Depression Rating Scale (HAM-D) after seven weeks of treatment, and remission was defined as recovery from depression (HAM-D <7) after seven weeks of treatment. In the BRITE study, ATR at one week predicted response and remission with 74 percent accuracy in subjects treated for seven weeks with escitalopram, which was statistically significant. Modeled study data also indicates that subjects who were ATR predicted non-responders to escitalopram had better outcomes if they were randomized to switch to bupropion, an antidepressant with a different mechanism of action than escitalopram.

“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.” An estimated 15 million people in the United States experience a depressive episode each year, and nearly 17 percent of adults will experience major depression in their lifetime.

Data from a study at Massachusetts General Hospital (MGH) investigating ATR as a predictor of treatment response was also recently published in European Neuropsychopharmacology. The MGH study evaluated ATR in 82 major depression patients receiving selective serotonin reuptake inhibitors (SSRI), and venlafaxine, and showed that use of ATR after the first week of antidepressant treatment may be predictive of treatment efficacy.

Continuing the ATR research effort, BRITE trial investigator Dr. Ian Cook at UCLA received a significant grant from the National Institutes of Mental Health to conduct a multi-year follow-on study of ATR called the PRISE-MD study (Personalized Response Indicators of SSRI Effectiveness in Major Depression). The PRISE-MD study will 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.

“There is now a growing body of literature supporting the potential role of frontal EEG, and ATR specifically, in the management of patients with major depression. We believe that the use of biomarkers such as ATR to optimize treatment efficacy and efficiency is well aligned with the objectives of current healthcare reform efforts,” said Nassib Chamoun, President and CEO of Aspect Medical Systems. “The UCLA grant award helps to validate the importance of this research and also cost-effectively advances the ATR program. We will continue to explore the commercial potential and partnership opportunities for ATR.”