CNS Response, Inc. Modifies rEEG(SM) Trial Protocol for 'Treatment-Resistant Depress...(h atarget enrollment of 120 subjects. .....),Health

Len Brandt, CEO of CNS Response, commented, "The original design of our Treatment-Resistant Depression Study developed from conversations with scientific and academic advisors, but there really was not a model for such a study. Following our quality assurance assessment, we reached the conclusion that the methodology was not as practical to implement as hoped. As a result, we are modifying the trial design in order to enhance its overall functionality and ensure the integrity of the results.

"This process will delay our ability to complete the multi-site study as originally projected. We expect, however, that the new trial design will ultimately improve the speed by which patients can be tested and treated. The new design will also allow us to introduce an additional arm involving patients with a different depression indication. We expect that the re-design will eliminate the need for a previously-contemplated second study and will now allow us to generate a robust set of results earlier than previously estimated. Together these two studies, along with the prior-reported successful pilot study, should provide CNS Response with a strong set of results showing the efficacy of rEEGSM in guiding patients who failed initial depressive treatment.

"The three key changes that we are making to the trial design involve un- blinding the treatment physicians, using the STAR*D treatment algorithm instead of TMAP, and adjusting certain trial subject qualifications.

"The need to blind the treatment physicians was a product of the original trial design which called for the patients, treating physicians, raters and rEEGSM technicians to be blind to which patients were in each arm of the study. This arrangement proved difficult to implement because many of the site's treating physicians felt the ethical need to understand the basis of treatment with selected medications in order to better dose and monitor the patients. Fu
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