Validation of a suite of ERP and QEEG biomarkers in a pre-competitive, industry-led study in subjects with schizophrenia and healthy volunteers

Complexity and lack of standardization have mostly limited the use of event-related potentials (ERPs) and quantitative EEG (QEEG) biomarkers in drug development to small early phase trials. We present results from a clinical study on healthy volunteers (HV) and patients with schizophrenia (SZ) that...

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Published in:	Schizophrenia research Vol. 254; pp. 178 - 189
Main Authors:	Cecchi, M., Adachi, M., Basile, A., Buhl, D.L., Chadchankar, H., Christensen, S., Christian, E., Doherty, J., Fadem, K.C., Farley, B., Forman, M.S., Honda, S., Johannesen, J., Kinon, B.J., Klamer, D., Marino, M.J., Missling, C., O'Donnell, P., Piser, T., Puryear, C.B., Quirk, M.C., Rotte, M., Sanchez, C., Smith, D.G., Uslaner, J.M., Javitt, D.C., Keefe, R.S.E., Mathalon, D., Potter, W.Z., Walling, D.P., Ereshefsky, L.
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier B.V 01-04-2023
Subjects:	Automated data analysis Biomarkers Electroencephalography - methods ERP Biomarker Qualification Consortium Event related potentials Evoked Potentials, Auditory - physiology Healthy Volunteers Humans Quantitative EEG Reproducibility of Results Schizophrenia Schizophrenia - diagnosis Test-retest reliability Schizophrenia ERP Biomarker Qualification Consortium Quantitative EEG Automated data analysis Test-retest reliability Event related potentials
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Summary:	Complexity and lack of standardization have mostly limited the use of event-related potentials (ERPs) and quantitative EEG (QEEG) biomarkers in drug development to small early phase trials. We present results from a clinical study on healthy volunteers (HV) and patients with schizophrenia (SZ) that assessed test-retest, group differences, variance, and correlation with functional assessments for ERP and QEEG measures collected at clinical and commercial trial sites with standardized instrumentation and methods, and analyzed through an automated data analysis pipeline. 81 HV and 80 SZ were tested at one of four study sites. Subjects were administered two ERP/EEG testing sessions on separate visits. Sessions included a mismatch negativity paradigm, a 40 Hz auditory steady-state response paradigm, an eyes-closed resting state EEG, and an active auditory oddball paradigm. SZ subjects were also tested on the Brief Assessment of Cognition (BAC), Positive and Negative Syndrome Scale (PANSS), and Virtual Reality Functional Capacity Assessment Tool (VRFCAT). Standardized ERP/EEG instrumentation and methods ensured few test failures. The automated data analysis pipeline allowed for near real-time analysis with no human intervention. Test-retest reliability was fair-to-excellent for most of the outcome measures. SZ subjects showed significant deficits in ERP and QEEG measures consistent with published academic literature. A subset of ERP and QEEG measures correlated with functional assessments administered to the SZ subjects. With standardized instrumentation and methods, complex ERP/EEG testing sessions can be reliably performed at clinical and commercial trial sites to produce high-quality data in near real-time.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0920-9964 1573-2509
DOI:	10.1016/j.schres.2023.02.018