CNS Response Provides Review of Treatment-Resistant Depressed Patients - A Pilot Study
November 07, 2008
Patients Using rEEG® -Guided Treatment Had Better Outcomes Than Patients Medicated According to TMAP Protocol
Costa Mesa, Calif. – November 7, 2008 – CNS Response, Inc. (OTCBB: CNSO) reported today the results of a study presented at the U.S. Psychiatric and Mental Health Congress by Charles DeBattista, D.M.H, M.D., Professor of Psychiatry and Behavioral Sciences, Director of Depression and Psychopharmacology Clinics, Stanford University School of Medicine, Palo Alto, Calif. The poster presentation, titled “Referenced-EEG Guidance of Medications for Treatment-Resistant Depressed Patients – A Pilot Study,” provided an analysis of medical outcomes of treatment-resistant depressed patients, when medicated based on a standard treatment approach, the TMAP depression algorithm (Texas Medication Algorithm Project), compared with patients medicated based on rEEG®-guided medication choices. The full poster presentation and analysis of results are available at www.cnsresponse.com/trdposterpresentation.
The study was a multicenter, randomized, blinded, controlled, parallel group with 18 patients. Patients included in the study had failed three or more antidepressant regimens with adequate dosing and treatment for a minimum of four weeks. The group underwent a washout of all current medications for at least five half-lives (elimination of 96.8 percent of all drugs from the body), and then had a rEEG analysis and report to determine a personalized medication strategy based on individual biomarkers of their brainwaves. Qualified patients were sent to the experimental group using rEEG–guided treatment, or to the control group using the modified TMAP for guidance.
“This pilot study included 18 treatment-resistant depressed (TRD) patients and formed the foundation of our larger academic study currently in process,” said Daniel Hoffman, M.D., Chief Medical Officer of CNS Response. “The same outcome measures, which were used in this pilot and the study currently underway, consisted of two self-rating scales: 1) QIDS (Quick Inventory of Depression Symptomatology) for depression; and 2) Q-LES-Q (Quality of Life Enjoyment and Satisfaction Questionnaire) for quality of life satisfaction.
“The patients fell into three groups: 1) those patients treated with rEEG guidance, which differed from TMAP guidance, 2) those patients treated with TMAP guidance, which differed from rEEG guidance, and 3) those patients whose treatment were equivalent under either protocol,” continued Dr. Hoffman. “Patients in the third group have been excluded from the current study now under way and were not included in the statistical analysis of the pilot study. It is an interesting statistic to note, however, that in the third group, TMAP and rEEG basically suggested equivalent treatment strategies in five (28 percent) of the eighteen patients’ analysis.
As shown in Figure 1, Patients in the first group, the rEEG group, recorded an average improvement in QIDS rating of 39.5% as compared to patients in the second group, the TMAP group, recording average improvement of 15.9%. As shown in Figure 2, on the Q-LES-Q rating, patients in the rEEG group recorded an average improvement of 14.9 points as compared to patients in the TMAP group recording an average improvement of 6.8 points.
Figure 1 QIDS Figure 2 Q-LES-Q
Median Mean Responders Median Mean Responders
rEEG 56.25 39.45 57.14 rEEG 11 14.9 2
TMAP 14.58 18.87 0 TMAP 7 6.8 0
The results of this pilot study showed patients guided with rEEG had statistically better outcomes than those medicated according to the TMAP standard. Statistical significance of the differences of the rEEG group and TMAP group means, using all of the bi-weekly measurements taken for these patients on the QIDS rating, was p<0.11, and on the Q-LES-Q rating was <0.039.
Len Brandt, CEO of CNS Response said, “Obviously we are pleased that this study demonstrates the advantages of rEEG over current pharmacotherapy guidance for treatment–resistant depression. The results of this study are consistent with other studies in this patient population, which were the subject of recently announced findings by United BioSource Corporation. They concluded ‘Evidence supporting rEEG appears superior to that supporting APA (American Psychiatric Association) or TMAP treatment guidelines.’ This is good news for managed care, insurance companies and Medicaid managed plans currently reviewing strategies for adherence to recently passed legislation mandating parity in addressing behavioral illnesses and recently-approved medical devices for depression.
The full poster presentation and analysis of results are available at www.cnsresponse.com/trdposterpresentation
Please join CNS Response CEO Len Brandt and CMO Daniel Hoffman for the company’s conference call, being held today, November 7, at 2:00 p.m. Eastern. Among other topics, Mr. Brandt and Dr. Hoffman will be discussing five recent poster presentations at the U.S. Psychiatric and Mental Health Congress.
The conference call dial-in number for both U.S. and international callers is 1-480-629-9039. Please dial in to the conference five minutes before the call is scheduled to begin. Ask the operator for the CNS Response call.
An audio replay of the conference call will be available from 5:00 p.m. EST, Friday, November 7, until Midnight EST, Friday, November 21, 2008. It can be accessed by dialing 1-303-590-3030 and entering conference number 3936802.
About CNS Response
CNS Response is a life-sciences data company whose patented system provides treatment guidance to psychiatrists and other physicians for patients with behavioral (mental or addictive) disorders. This technology allows CNS Response to create and provide simple reports (“rEEG® Reports”) that specifically guide physicians to treatment strategies based on the patient’s own physiology.
rEEG® utilizes traditional electroencephalography (EEG) in conjunction with a normative
database and a proprietary clinical (symptomatic) database to identify the following: (1) medication classes most likely to be needed; and (2) medications within these classes with the most probable treatment potential for each patient. Reports are provided to physicians in a relationship analogous to that of a reference laboratory. Prospective, retrospective and field studies of treatment-resistant patients have reported treatment success of 70% or greater in managed care, outpatient psychiatric and residential substance abuse clinical settings.
In addition to providing analytical support to physicians, CNS Response is also an aid to pharmaceutical developers, who can use rEEG to (1) stratify study populations to improve the success of FDA clinical trials; (2) provide insight on effective therapeutic dosing of investigational drugs; (3) identify additional indications for psychiatric medications; (4) provide insight into effective drug combinations; and (5) discover opportunities for decision analytics and support. In addition to these applications, CNS Response continues to investigate the use of rEEG analysis for development of proprietary pharmaceutical opportunities.
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995
Except for the historical information contained herein, the matters discussed are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. These statements involve risks and uncertainties as set forth in the Company's filings with the Securities and Exchange Commission. These risks and uncertainties could cause actual results to differ materially from any forward-looking statements made herein.
Contact:
Investor and Media Relations:
Marty Tullio
McCloud Communications LLC
949.553.9748
marty@mccloudcommunications.com
###
Back to News and Press