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CNS Response, Inc. Modifies rEEG(SM) Trial Protocol for 'Treatment-Resistant Depression' Study
Date:10/25/2007

rther, the fact that the treating physician was blind prevented the physician from considering the rEEGSM report alongside the standard clinical information of the patient when developing the treatment strategy. Of course, in clinical practice this integration of rEEG and clinical data is exactly what is done. So, this change will better mimic general clinical practice.

"As a result, we have concluded that a treatment design that attempts to blind the treating physician is operationally impractical. To adjust the design so that the measurement of outcomes is insulated from the treating physician, we will have an independent rater at all trial sites that will remain blind during the data collection and evaluation process. We will also use standard accepted patient self-rating scales as primary measures of outcome.

"Our interest in switching from TMAP, treatment algorithm to STAR*D is related to functionality and efficiency. The original study design involved comparing treatment results of patients guided using rEEGSM versus those directed by TMAP. However, one of TMAP's advantages in the field - providing multiple options to the treating physician - caused complications during the study.

"It was clear to our advisors that if we were to continue with the TMAP, a separate TMAP expert would be needed to guide the treating physicians. STAR*D, the nation's largest real-world study of depression, has recently completed an analysis suggesting treatment options with the highest probability of success for patients at various stages of treatment. By choosing the options shown to have the highest success, we can have a comparable arm with less variability and less need for expert interpretation. As such, we have concluded that the treatment design can be simplified by using the STAR*D results in the control arm of the study.

"Lastly, we encountered two obstacles with the trial subject qualifications that required attention. The first involved trial subje
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SOURCE CNS Response, Inc.
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