CNS Amends Trial for Treatment-Resistant Depression

CNS Response, a Costa Mesa, CA, company whose database-analysis technology helps guides psychiatrists toward appropriate treatments for mentally ill patients, is amending the design of its ongoing trial for treatment-resistant depression.

The changes — unblinding the treating physicians, using a new treatment algorithm as a comparative measure for CNS’s technology, and modifying the inclusion criteria of the trial subjects — follow a quality assurance analysis performed by CNS executives, the company’s scientific advisory board and its regional medical directors, specific trial site medical leadership, and the clinical study management team.

CNS’s system, known as rEEG (for referenced electroencephalogram) utilizes EEG in conjunction with a normative database and a clinical database to identify abnormal patient physiology. Appropriate medications are then statistically selected to normalize discovered abnormalities.

The current nationwide study was designed to examine the efficacy of rEEG-guided pharmacotherapy in comparison to generally accepted therapies for individuals with treatment-resistant depression. In a pilot study, 87% of patients guided by rEEG were successfully treated as compared with 17% of patients treated without CNS’s analytical reports.

Implementing the above-mentioned changes to the current trial will delay interim an completed results. The amendment, however, also creates a second depressive patient group study that will be started alongside the first, which will deliver results for a second study sooner than originally projected by CNS.

“This process will delay our ability to complete the multi-site study as originally projected,” said CNS CEO Len Brandt, in a statement. “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.”

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