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

COSTA MESA, Calif., Oct. 25 /PRNewswire-FirstCall/ -- CNS Response, Inc. (OTC Bulletin Board: CNSO) announced today that it has conducted a quality assurance analysis of its current multi-center trial of rEEGSM -guided pharmacotherapy for individuals with treatment-resistant depression. Based on the evaluation, CNS Response is amending the design of the study in order to address issues related to functionality and operability.

Changes to the trial design will include (i) un-blinding the treatment physicians, (ii) incorporating the STAR*D treatment algorithm instead of the Texas Medication Algorithm Project (TMAP) as a comparative measure against which rEEGSM will be evaluated, and, (iii) modifying the inclusion criteria of the trial subjects. The modifications resulted from a joint review by CNS Response's executive staff, the Company's Scientific Advisory Board, its regional medical directors, specific trial site medical leadership, and the clinical study management team.

Implementation of these changes will result in a delay in interim and completed trial results from this study. The delay is dependent on the individual site's approval processing of the protocol amendment. The amendment, however, also creates a second depressive patient group study that will be started alongside the first. It will leverage, recruiting, trial management and site training efforts associated with the first study. This will result in CNS Response reporting results of this second study sooner than previously anticipated by corporate plans.

The current nationwide study was designed to examine the efficacy of rEEGSM-guided pharmacotherapy in comparison to generally accepted therapies for individuals with treatment-resistant depression. This follows a pilot study in which 87% of patients guided by rEEGSM were successfully treated as compared to 17% of patients treated without the benefits of rEEGSM analytical reports. In total, eleven sites were to participate wit
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SOURCE CNS Response, Inc.
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