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SchizophreniaNCT04025502

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

An observational study of Schizophrenia, run by ERP Biomarker Qualification Consortium at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Schizophrenia
What is being tested?
Event-Related Potentials (ERP) and Electroencephalogram (EEG) testing with the COGNISION® System
Type of treatment
Medical device
How many people
161 participants
Where
4 sitesUnited States
Study dates
7 Oct 2019to 31 Jan 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: There will be four different sites where the participants will be selected in the following states: California, New Jersey, and New York. Recruitment methods: * Database of individuals who have agreed to be contacted * Advertisements * Physician to physician referrals

Who may be able to join

  • Healthy male and female subjects 21-50 years of age (inclusive).
  • Are not currently or have not participated in any other clinical studies within 30 days of Screening.
  • Ability to understand the requirements of the study, provide written informed consent, abide by the study procedures, and agree to return for the required assessments.
  • Subject is in good and stable health with no history or evidence of clinically relevant medical or neuropsychiatric illness.
  • Fluent in English, even if English is not the primary language. Subjects must hold a U.S. citizenship only for eligibility to participate.
  • Otherwise healthy male and female subjects 21-50 years of age (inclusive).
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  • Are not currently or have not participated in any other clinical studies within 30 days of Screening.
  • Ability to understand the requirements of the study, provide written informed consent, abide by the study restrictions, and agree to return for the required assessments.
  • Current diagnosis of schizophrenia.
  • Duration of schizophrenia illness ≥ 1 years.
  • Clinically stable and in the residual (non-acute) phase of their illness for at least 6 weeks prior to the study as evidenced by a stable medication regimen and no recent hospitalizations for acute Schizophrenia. The subject's clinical stability is ultimately up to the Investigator.
  • Maintained on a stable regimen of antipsychotic and/or permitted concomitant medications for at least 6 weeks prior to screening and during the study.
  • Subjects receiving treatment with up to 2, first or second-generation antipsychotics or other concomitant medications commonly prescribed to this patient population, may be included. (see Allowed Medications List)
  • Fluent in English, even if English is not the primary language. Subjects must hold a U.S. citizenship only for eligibility to participate.

Who cannot join

  • Illicit drug use as determined by the saliva drug screen.
  • Current alcohol abuse as determined by the Investigator; or subject regularly consumed ≥3 alcoholic drinks/day during the 3 months prior to screening. One alcohol drink is approximately equivalent to: beer: 284 mL; wine: 125 mL (4 oz); or distilled spirits: 25 mL (1 oz).
  • Known (identifiable) biological family history of Schizophrenia spectrum disorders in a first or second degree relative.
  • Use of any first generation, sedating H1 antihistamines within 1 week prior to Screening or during the study. (see Medication Approval List)
  • Use of any sedative-hypnotic medications within 1 week prior to Screening or during the study. (see Medication Approval List)
  • Use of any other psychoactive medication known to interfere with ERP assessments within 1 week prior to Screening or during the study (see Medication Approval List).
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  • Evidence or history of significant cognitive disorders, or other injuries, conditions, impairments, or situations that in the judgement of the Investigator would prevent safe and satisfactory completion of the study protocol.
  • Evidence or history of psychiatric illness as determined by the Mini International Neuropsychiatric Interview (MINI) for Psychotic Disorders.
  • Evidence of cognitive impairment as determined by performing ≥ 1.5 standard deviations lower compared to the age, sex, and education corrected mean on either the BACS Symbol Coding and/or Verbal Memory.
  • Significant intellectual disability as evidenced by a standardized WRAT-4 Reading Test standardized score < 70.
  • Unable to detect a 1000 and 2000 Hz tone at 40 dB in both ears.
  • Unable to tolerate the electrode cap for the duration of the testing session.
  • Known allergy to latex.
  • Use of products containing nicotine and/or caffeine 60 minutes prior to EEG/ERP testing.
  • Illicit drug use as evidenced by the saliva drug screen.
  • Current alcohol abuse as determined by the Investigator; or subject regularly consumed ≥3 alcoholic drinks/day during the 3 months prior to screening. One alcohol drink is approximately equivalent to: beer: 284 mL; wine: 125 mL (4 oz); or distilled spirits: 25 mL (1 oz).
  • Use of any first-generation, sedating H1 antihistamines within 1 week prior to Screening or during the study (see Medication Approval List).
  • Use of any sedative-hypnotic medications within 1 week prior to Screening or during the study. (see Medication Approval List)
  • Use of any other psychoactive medication known to interfere with ERP assessments within 1 week prior to Screening or during the study (see Allowed Medications List).
  • Evidence or history of significant cognitive disorders, or other injuries, conditions, impairments, or situations that in the judgement of the Investigator would prevent safe and satisfactory completion of the study protocol.
  • Failure to confirm a diagnosis of Schizophrenia by the Investigator.
  • Significant intellectual disability as evidenced by a standardized WRAT-4 Reading Test score < 70.
  • Have no more than a moderate severity rating on hallucinations and delusions as evidenced by a PANSS items P1 ≥ 4 and P3 ≥ 4.
  • Have no more than a moderate severity rating on positive formal thought disorder as evidenced by a PANSS items G9 ≥ 4 and P2 ≥ 4.
  • Presence of more than minimal extrapyramidal symptoms as evidenced by a SAS score > 6.
  • Presence of more than minimal level of depressive symptoms as evidenced by a CDSS score ≥ 10.
  • Unable to detect a 1000 and 2000 Hz tone at 40 dB in both ears.
  • Unable to tolerate the electrode cap for the duration of the testing session.
  • Known allergy to latex.
  • Use of products containing nicotine and/or caffeine 60 minutes prior to EEG/ERP testing.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Collaborative Neuroscience Network, LLC

    Garden Grove, California, 92845

  • Hassman Research Institute

    Marlton, New Jersey, 08053

  • New York State Psychiatric Institute

    New York, New York, 10032

  • Collaborative Neuroscience Network, LLC

    Torrance, California, 90502

Other trials in United States

About this study

Official title: A Multi-Center Study of Event-Related Potential (ERP) Biomarkers in Subjects With Schizophrenia and Healthy Volunteer Subjects

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.

Read the detailed description

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.

Conditions
Schizophrenia
Being tested
Event-Related Potentials (ERP) and Electroencephalogram (EEG) testing with the COGNISION® System
Keywords
ERP, EEG, Event-related potential, MMN, Schizophrenia, Electroencephalogram, Mismatch Negativity, N100, P3a, P3b
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT04025502
Study groupRoleWhat they receive
Healthy Volunteer Subjects (HV)Male and female subjects 21-50 years of age, who are in good and stable health with no history or evidence of clinically relevant medical or neuropsychiatric illness. Healthy Volunteer Subjects will undergo Event-Related Potential (ERP)/electroencephalogram (EEG) testing with the COGNISION® System.
Receives: Device: Event-Related Potentials (ERP) and Electroencephalogram (EEG) testing with the COGNISION® System
Subjects with Schizophrenia (SZ)Otherwise healthy male and female subjects 21-50 years of age, who have a current diagnosis of Schizophrenia with a duration of illness greater than or equal to one year. Subjects with Schizophrenia (SZ) will undergo Event-Related Potential (ERP)/electroencephalogram (EEG) testing with the COGNISION® System.
Receives: Device: Event-Related Potentials (ERP) and Electroencephalogram (EEG) testing with the COGNISION® System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Amplitude (in microvolts) for parameters from the ERP tests.

    Amplitude (in microvolts) for the following parameters from the ERP tests will be collected as primary endpoints:

    1. Passive, Tone-deviant, Auditory Oddball ERP
    • N100
    • MMN
    • P3a
    1. Passive, Duration-deviant, Auditory Oddball ERP
    • N100
    • MMN
    • P3a
    1. Active, Auditory Oddball ERP
    • N100
    • P3b

    Measured: 12-18 months

  2. Latency (in milliseconds) for parameters from the ERP tests.

    Latency (in milliseconds) for the following parameters from the ERP tests will be collected as primary endpoints:

    1. Passive, Tone-deviant, Auditory Oddball ERP
    • N100
    • MMN
    • P3a
    1. Passive, Duration-deviant, Auditory Oddball ERP
    • N100
    • MMN
    • P3a
    1. Active, Auditory Oddball ERP
    • N100
    • P3b

    Measured: 12-18 months

  3. Task accuracy from the behavioral response during the active, auditory oddball ERP test.

    Task accuracy as a percentage of correct behavioral responses during the active, auditory oddball ERP test will be collected as a primary endpoint.

    Measured: 12-18 months

  4. Reaction time from the behavioral response during the active, auditory oddball ERP test.

    Reaction time for the correct behavioral responses to the test measured in milliseconds will be collected as a primary endpoint during the active, auditory oddball ERP test.

    Measured: 12-18 months

  5. Total Power from the auditory steady-state response (ASSR) paradigm.

    Total Power (measured in µv2/Hz) will be collected during the ASSR paradigm as a primary endpoint.

    Measured: 12-18 months

  6. Inter-trial coherence (ITC) from the auditory steady-state response (ASSR) paradigm.

    Inter-trial coherence (ITC) measured on a scale between 0 (no coherence) and 1 (maximum coherence) will be collected during the ASSR paradigm as a primary endpoint.

    Measured: 12-18 months

  7. Absolute Power for Pharmaco-EEG parameters per IPEG guidelines.

    Absolute Power (measured in µv2/Hz) will be collected from the Resting State EEG as a primary endpoint for the following Pharmaco-EEG parameters:

    • Delta power
    • Theta power
    • Alpha power
    • Beta power
    • Gamma power

    Measured: 12-18 months

  8. Relative Power for Pharmaco-EEG parameters per IPEG guidelines.

    Relative Power measured on a scale from 0 (no power in frequency band) to 1 (all EEG power in that frequency band) will be collected from the Resting State EEG as a primary endpoint for the following Pharmaco-EEG parameters:

    • Delta power
    • Theta power
    • Alpha power
    • Beta power

    Measured: 12-18 months

  9. Dominant frequency in the Alpha frequency band per IPEG guidelines

    Dominant frequency measured in Hz in the frequency interval between 6.0 and < 12.5 Hz will be collected from the Resting State EEG as a primary endpoint.

    Measured: 12-18 months

  10. Theta/Beta ratio and Slow Wave index per IPEG guidelines.

    Theta/Beta ratio and Slow Wave index (Alpha/Delta+Theta) measured in percentage will be collected from the Resting State EEG as primary endpoints.

    Measured: 12-18 months

  11. Functional assessments as derived from the Brief Assessment of Cognition in Schizophrenia (BACS).

    The following parameters will be collected for the BACS:

    BACS Variable Ranges Description Range Low Range High Unit Verbal Memory Total Score 0 75 n/a Digit Sequencing 0 28 n/a Token Motor Total Correct 0 100 n/a Verbal Fluency Total 0 100 n/a Symbol Coding 0 110 n/a Tower of London 0 22 n/a Verbal Memory T-Score -100 100 n/a Digit Sequencing T-Score -100 100 n/a Token Motor T-Score -100 100 n/a Verbal Fluency T-Score -100 100 n/a Symbol Coding T-Score -100 100 n/a Tower of London T-Score -100 100 n/a

    Measured: 12-18 months

  12. Functional assessments as derived from the Positive and Negative Symptom Scale for Schizophrenia (PANSS).

    The PANSS items are divided into three sections: Positive symptoms, negative symptoms, and general symptoms. The following parameters will be collected:

    PANSS Variable Ranges Description Range Low Range High Unit PANSS Items 1-30 1 7 n/a PANSS Total Score 30 210 n/a

    Measured: 12-18 months

  13. Functional assessments as derived from the Virtual Reality Functional Capacity Assessment Tool (VRFCAT).

    The following parameters for the VRFCAT will be collected:

    VRFCAT Variable Ranges Description Range Low Range High Unit VRFCAT- Adjusted Total Time 0 60000 msec VRFCAT- Total Error Count 0 60 n/a VRFCAT- Total Forced Progressions 0 12 n/a Adjusted Total Time T-Score -100 100 n/a Total Errors T-Score -100 100 n/a Total Forced Progressions T-Score -100 100 n/a

    Measured: 12-18 months

Secondary outcomes (1)

  1. Correlations between EEG/ERP measures and psychometric measures in Schizophrenia subjects.

    Pearson Correlation coefficients between EEG/ERP measures and scores from the functional assessments (BACS, PANSS, and VRFCAT) will be collected as secondary outcome measures.

    Measured: 12-18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jul 2019
  2. Study start7 Oct 2019
  3. Primary completion29 Dec 2020
  4. Study completion31 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
161 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04025502
Sponsor's protocol ID
EBS-A
Status last verified
Feb 2021
First submitted
23 Jun 2019
Last updated
24 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Jobert M, Wilson FJ, Ruigt GS, Brunovsky M, Prichep LS, Drinkenburg WH; IPEG Pharmaco-EEG Guidelines Committee. Guidelines for the recording and evaluation of pharmaco-EEG data in man: the International Pharmaco-EEG Society (IPEG). Neuropsychobiology. 2012;66(4):201-20. doi: 10.1159/000343478. Epub 2012 Oct 12.

    PubMed 23075830

  • Umbricht D, Krljes S. Mismatch negativity in schizophrenia: a meta-analysis. Schizophr Res. 2005 Jul 1;76(1):1-23. doi: 10.1016/j.schres.2004.12.002. Epub 2005 Jan 23.

    PubMed 15927795

  • Light GA, Hsu JL, Hsieh MH, Meyer-Gomes K, Sprock J, Swerdlow NR, Braff DL. Gamma band oscillations reveal neural network cortical coherence dysfunction in schizophrenia patients. Biol Psychiatry. 2006 Dec 1;60(11):1231-40. doi: 10.1016/j.biopsych.2006.03.055. Epub 2006 Aug 7.

    PubMed 16893524

  • Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.

    PubMed 9881538

  • Buchanan RW, Davis M, Goff D, Green MF, Keefe RS, Leon AC, Nuechterlein KH, Laughren T, Levin R, Stover E, Fenton W, Marder SR. A summary of the FDA-NIMH-MATRICS workshop on clinical trial design for neurocognitive drugs for schizophrenia. Schizophr Bull. 2005 Jan;31(1):5-19. doi: 10.1093/schbul/sbi020. Epub 2005 Feb 16.

    PubMed 15888422

  • Buchanan RW, Keefe RS, Umbricht D, Green MF, Laughren T, Marder SR. The FDA-NIMH-MATRICS guidelines for clinical trial design of cognitive-enhancing drugs: what do we know 5 years later? Schizophr Bull. 2011 Nov;37(6):1209-17. doi: 10.1093/schbul/sbq038. Epub 2010 Apr 21.

    PubMed 20410237

Questions about this trial

What is this clinical trial studying?

An observational study of Schizophrenia, run by ERP Biomarker Qualification Consortium at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Amplitude (in microvolts) for parameters from the ERP tests. (time frame: 12-18 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04025502, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2021.

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