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

Summary

This is an observational, non-interventional study that will recruit Healthy Volunteers (HV) and subjects with clinically confirmed Schizophrenia (SZ). The purpose of this study is to establish the mean and variance across the HV and SZ cohorts, sites, and repeated tests of the electroencephalogram(EEG)/Event-related potentials (ERP) measures.

Conditions

• Schizophrenia

Interventions

DEVICE

Event-Related Potentials (ERP) and Electroencephalogram (EEG) testing with the COGNISION® System

The testing protocol consists of an auditory oddball Event-Related Potential (ERP) paradigm, 40Hz ASSR, and the collection of 6 minutes of resting electroencephalogram (EEG). During the ERP paradigm a variety of auditory stimuli are played through the system's earphones while voltage potentials are recorded from the subject's scalp. At the end of the ERP session, 6 minutes of EEG data will be recorded while the subject is resting. The entire procedure, including set up, instructions to the subject and actual test is expected to take 60-75 minutes.

Sponsors & Collaborators

• Novartis

  collaborator INDUSTRY

• Alkermes, Inc.

  collaborator INDUSTRY

• Anavex Life Sciences Corp.

  collaborator INDUSTRY

• Merck Sharp & Dohme LLC

  collaborator INDUSTRY

• Takeda

  collaborator INDUSTRY

• Sage Therapeutics

  collaborator INDUSTRY

• H. Lundbeck A/S

  collaborator INDUSTRY

• Astellas Pharma Inc

  collaborator INDUSTRY

• Apex Innovative Sciences

  collaborator UNKNOWN

• Columbia University

  collaborator OTHER

• COGNISION

  collaborator UNKNOWN

• ERP Biomarker Qualification Consortium

  lead INDUSTRY

Principal Investigators

• Marco Cecchi, PhD · ERP Biomarker Qualification Consortium

Eligibility

Min Age

21 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-10-07

Primary Completion

2020-12-29

Completion

2021-01-31

Countries

• United States

Study Locations