Abstract

Abstract Title: The use of the Psychiatric Electroencephalography Evaluation Registry (PEER) to personalize pharmacotherapy

Author: George Carpenter IV

Purpose: This study (interim report) aims to determine whether Psychiatric Electroencephalography Evaluation Registry (PEER) Interactive (an objective, adjunctive tool based on a comparison of a quantitative electroencephalogram to an existing registry of patient outcomes) is more effective than the current standard of care in treatment of subjects suffering from depression. Patients and methods: This is an interim report of an ongoing, 2-year prospective, randomized, double blind, controlled study to evaluate PEER Interactive in guiding medication selection in subjects with a primary diagnosis of depression vs standard treatment. Subjects in treatment at two military hospitals were blinded as to study group assignment and their self-report symptom ratings were also blinded. Quick Inventory of Depressive Symptomatology, Self-Report (QIDS-SR16) depression scores were the primary efficacy endpoint. One hundred and fifty subjects received a quantitative electroencephalography exam and were randomized to either treatment as usual or PEER-informed pharmacotherapy. Subjects in the control group were treated according to Veterans Administration/Department of Defense Guidelines, the current standard of care. In the experimental group, the attending physician received a PEER report ranking the subject’s likely clinical response to on-label medications. Results: In this post hoc interim analysis subjects were separated into Report Followed and Report Not Followed groups – based on the concordance between their subsequent treatment and PEER medication guidance. We thus evaluated the predictive validity of PEER recommendations. We found significantly greater improvements in depression scores (QIDS-SR16 P,0.03), reduction in suicidal ideation (Concise Health Risk Tracking Scale-SR7 P,0.002), and post-traumatic stress disorder (PTSD) score improvement (PTSD Checklist Military/Civilian P,0.04) for subjects treated with PEER-recommended medications compared to those who did not follow PEER recommendations. Conclusion: This interim analysis suggests that an objective tool such as PEER Interactive can help improve medication selection. Consistent with results of earlier studies, it supports the hypothesis that PEER-guided treatment offers distinct advantages over the current standard of care. Keywords: EEG, depression, antidepressant, suicide, predictive analytics Word count: 313

Co Author/Co-Investigator Names/Professional Title: Dr. Dan V Iosifescu, PhD: Director, Adult Psychopharmacology Program, Psychiatry and Neuroscience, Icahn School of Medicine at Mount Sinai, New York, NY, USA Dr. Robert J Neborsky, MD: Faculty, School of Medicine, University of California, San Diego, CA, USA; University of California, Los Angeles, CA, USA; and Medical Corps, US Navy Dr. Robert J Valuck, PhD: Faculty, Pharmacy, Epidemiology, and Family Medicine, University of Colorado, Denver, CO, USA; Center for Pharmaceutical Outcomes Research, University of Colorado, Denver, CO, USA; and Colorado Consortium for Prescription Drug Abuse

Funding Acknowledgement (If Applicable): Funding for the study provided by the Sponsor - MYnd Analytics, Inc. and the Department of Defense.