CNS Response, Inc. (OTCBB: CNSO) reported the results of a landmark study presented by Charles DeBattista, D.M.H, M.D., at the U.S. Psychiatric and Mental Health Congress. The poster presentation, titled Referenced-EEG® (rEEG) Efficacy Compared to STAR*D For Patients With Depression Treatment Failure: First Look At Final Results, highlighted a dramatic improvement in personalized medicine technology for use in treatment of patients with depression. In this study, rEEG proved effective at predicting medication response for treatment-resistant patients approximately 65 percent of the time.
The study included 114 patients in 12 medical centers, including Harvard, Stanford, Cornell, UCI and Rush. The 12-week study found that rEEG significantly outperformed the modified STAR*D treatment algorithm. The difference, or separation, between rEEG and the control group was 50 and 100 percent for the study's two primary endpoints. Typically, separation between a new treatment and a control group is about 10 percent in antidepressant studies.
"These outcomes are consistent with previous rEEG studies, which included three prospective, controlled trials and eight case series, but the robustness and statistical significance of these results exceeded our expectations," said CNS president and chief medical officer Daniel Hoffman, M.D.
"Psychiatry has lacked useful laboratory tests to select medications for treatment-resistant depressed patients. While needing further study, this trial is one of the larger ones to demonstrate that there may be a role for technology that assists physicians in selecting better treatment options for their patients," said Dr. Charles DeBattista, an award-winning doctor at Stanford University Medical Center, who helped lead the study on rEEG.
Depression costs U.S. employers $83 billion annually, with treatment-resistant depression accounting for over half of that cost. On average, these patients cost $8,500 more per year than patients with ordinary depression. rEEG is the first objective, physiology-based, personalized medical technology consistently shown to guide psychiatrists to appropriate treatment for the most challenging patients.
The CNS Response study, the largest in the company's history, was a randomized, blinded, controlled, parallel group, multicenter study. The patients in the study experienced depression treatment failure of one of more SSRIs and/or had failure with at least two classes of antidepressants. The patients fell into two groups: 1) those treated with rEEG medication guidance, and 2) those treated with the modified STAR*D treatment algorithm.
"This is the promise of personalized medicine, tailoring therapies to the unique medication response profile of each individual patient," said George Carpenter, chief executive officer of CNS Response, Inc., which developed the patented technology. "Those suffering from the most resistant forms of depression will now have an effective treatment option, and doctors will no longer have to play an extended and costly guessing game to see what works best."
Maternal stress and depression alter infant DNA, with potential lifelong impact