Event-Related Potential (ERP) Biomarkers in Subjects With Schizophrenia and Healthy Volunteer Subjects

Among the most replicated pathophysiological findings in schizophrenia is the impairment of Event-Related Potentials (ERPs) recorded during the auditory oddball procedure. In this procedure, time-locked electroencephalogram (EEG) responses are recorded during auditory processing of frequent and rare tones differing in pitch or duration. In addition, a smaller but substantial literature has reported deficits in the auditory steady-state EEG response (ASSR) to a 40 Hz train of auditory tones in subjects with schizophrenia versus healthy control subjects. While measurement of ERPs in the drug development setting has shown promise, the instruments, infrastructure, and standardization of these methods has lagged. New, portable, easy-to-use, Food and Drug Administration (FDA)-approved devices are now available for the automated collection and analysis of EEG and ERP data. This observational, non-interventional, clinical study will recruit healthy volunteer subjects (HV) and subjects with clinically confirmed schizophrenia (SZ), and will establish the mean and variance across HV and SZ cohorts, sites and repeated tests, of EEG and ERP measures collected with a standardized EEG/ERP device. The study will also examine the relationship between specific EEG/ERP features and measures of positive, negative, and cognitive symptoms and global function in SZ subjects. The data collected in this study is intended to replicate published observations of the magnitude of deficit in ERPs in SZ versus HV subjects, and to support the design of subsequent interventional studies that will make use of ERPs. Furthermore, these data will be submitted to support qualification of the ERP biomarkers through the FDA Drug Development Tools Biomarker Qualification Program.