BRITE Major Depression National Study

A trial to assess accuracy of Aspect's brain assessment technology in predicting the effectiveness of antidepressant medications

Aspect Medical Systems, Inc. (NASDAQ: ASPM) is collaborating with leading depression researchers at nine academic facilities across the United States to initiate the BRITE Major Depression trial (Biomarkers for Rapid Identification of Treatment Efficacy in Major Depression). The study seeks to determine the accuracy of using Aspect's brain assessment technology that analyzes electrical activity in the brain to predict the effectiveness of antidepressant medications.

"The current approach to treating patients suffering from depression is based largely on trial and error. In many cases, it can take months before a patient responds to antidepressant medication and feels better," 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 builds upon previous research to establish whether brain monitoring technology can determine much earlier - in as soon as one week - whether a patient will respond to a specific antidepressant medication." Earlier research conducted at Massachusetts General Hospital in Boston, and Cedars-Sinai and UCLA in Los Angeles, found that Aspect's brain assessment technology predicted response to antidepressant treatment with more than 80 percent accuracy.

In the United States alone, more than 15 million people experience a major depressive episode each year, and nearly 17 percent of adults will experience major depression in their lifetime. Currently, practitioners have many treatment options to choose from in caring for depressed patients. Most patients being treated for major depression are prescribed an antidepressant medication, usually a selective serotonin reuptake inhibitor (SSRI). While treatment with an SSRI will eventually lead to remission in the majority of treated patients, many will require a second, third or fourth treatment before experiencing relief. The opportunity to improve this sequential treatment process was highlighted in a recent study sponsored by the National Institutes of Mental Health called STAR*D (Sequenced Treatment Alternatives to Relieve Depression). The STAR*D trial evaluated more than 4,000 depressed patients to determine how to better manage patients who fail to respond to a standard trial of treatment with an SSRI by defining which subsequent treatment strategies provide the best results with the least side effects.

"Recent results from the first phase of the STAR*D trial showed that only one-third of patients receiving an SSRI achieved remission on the initial treatment. One in three depressed patients who did not achieve remission became symptom-free with the help of an additional medication and one in four achieved remission after switching to a different antidepressant." said Maurizio Fava, M.D., associate chief of Psychiatry for Clinical Research at the Massachusetts General Hospital and clinical investigator participating in both the STAR*D and BRITE trial. "This means that the majority of patients who take antidepressants must go through multiple rounds of treatment before finding relief. We also know that many patients become discouraged and give up when repeated attempts at treatment prove ineffective or cause severe side effects. This underscores why the BRITE trial is relevant and important. A technology that could help clinicians identify the best antidepressant therapies so that patients feel better sooner, could profoundly impact clinical practice, treatment adherence and quality of life for millions of patients."

Clinical research sites participating in the BRITE trial include:

-- Harbor-UCLA Medical Center, Los Angeles, CA

-- Semel Institute for Neuroscience and Human Behavior at UCLA, Los Angeles, CA

-- Massachusetts General Hospital, Boston MA

-- Northwestern University, Chicago IL

-- Baylor College of Medicine, Houston TX

-- Cedars-Sinai Medical Center, Los Angeles, CA

-- University of Pittsburgh, Pittsburgh, PA

-- UT Southwestern Medical School, Dallas, TX

-- UCSD, San Diego, CA

 

The BRITE trial is currently enrolling patients at most of the trial sites and is open to men and women between ages 21-75 who have been diagnosed with major depression with the most recent episode lasting two or more weeks, and who are not currently on a stable medication regimen. Participants in the trial will be evaluated, placed on FDA-approved medication (Lexapro, Wellbutrin XL or a combination) and closely monitored for 13 weeks; nine of those weeks will include office visits that involve a brief EEG recording. The study is blinded so that neither physicians nor participants will have access to the individual processed EEG results until the conclusion of the nationwide trial.

"The BRITE trial represents an important milestone for Aspect to develop a better understanding of the role and value of Aspect's brain assessment technology in helping clinicians improve the care of patients suffering from depression," said Philip Devlin, vice president and general manager of Aspect's neuroscience division. "We believe that this trial will help us to prospectively confirm the predictive accuracy of our present brain monitoring algorithm and better define the optimum design of our subsequent pivotal trial."

Aspect's neuroscience division was founded to expand upon the company's expertise in brain monitoring to improve patient care for people suffering from neurologically based diseases. In May 2005 the company entered into a $25 million strategic alliance with Boston Scientific to support the development and commercialization of neuroscience-related products. "In the past year, Aspect has made significant progress in defining the necessary research and clinical milestones to develop new brain assessment tools that aid the treatment of neurological conditions like depression," said Larry Best, executive vice president for finance and administration, and chief financial officer of Boston Scientific. "We remain confident in Aspect's expertise and we look forward to working with Aspect to support the BRITE trial and to ultimately introduce innovative products that address this significant clinical need."

 

 

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The BRITE trial is currently (3/28/2006) enrolling patients at most of the trial sites and is open to men and women between ages 21-75 who have been diagnosed with major depression with the most recent episode lasting two or more weeks, and who are not currently on a stable medication regimen. Please volunteer by contacting the research institutions listed above.