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

cts whose treatment strategies would be similar under either TMAP or rEEGSM. In these situations, there is actually nothing to test, since under random assignment to either study arm, the patient would be treated the same. In addition to this being costly, depending on how such patients are assigned to either arm of the study, there is a chance that these patients can obfuscate study results. To combat this potential problem, we have concluded that the treatment design should exclude patients who would be treated the same way under both treatment arms.

"The second trial qualification involved defining treatment-resistant patients as those who failed a minimum of three previous treatment efforts. We found many challenges with this strict classification. In some cases, failed treatment included medication that had been successful for many years prior to failure but eventually lost effectiveness. While other patients who had seemingly failed many medications, in actuality, only failed a single class of medication, Selective Serotonin Reuptake Inhibitors or SSRIs. Still, others seemed to meet the qualifications, but were minimally dosed in some of their prior medication treatments. Categorizing these individuals as truly treatment-resistant is debatable.

"We concluded, therefore, that the trial design should be opened to include any patient that has failed at least one medication effort. If the subject has only been treated with SSRIs, he or she will be treated with one trial protocol. This group will receive either Venlafaxine XR, the medication that showed the greatest treatment success for SSRI non-responders in the STAR*D study, or a rEEGSM guided treatment.

"If, however, the patient has been previously treated with more than the SSRI medication class, then he or she will be treated with another trial protocol. This group will get either STAR*D guided medication in a defined treatment algorithm or rEEGSM recommended treatment.

"As a result, w
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SOURCE CNS Response, Inc.
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