Status:
COMPLETED
Event-Related Potential (ERP) Biomarkers in Subjects With Schizophrenia and Healthy Volunteer Subjects
Lead Sponsor:
ERP Biomarker Qualification Consortium
Collaborating Sponsors:
Novartis
Alkermes, Inc.
Conditions:
Schizophrenia
Eligibility:
All Genders
21-50 years
Brief 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 me...
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-lock...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Healthy Volunteer Subjects (HV)
- 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.
- Exclusion Criteria for Healthy Volunteer Subjects (HV)
- 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).
- 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.
- Inclusion Criteria for Subjects with Schizophrenia (SZ)
- Otherwise 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 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.
- Exclusion Criteria for Subjects with Schizophrenia (SZ)
- 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.
Exclusion
Key Trial Info
Start Date :
October 7 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT04025502
Start Date
October 7 2019
End Date
January 31 2021
Last Update
February 24 2021
Active Locations (4)
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1
Collaborative Neuroscience Network, LLC
Garden Grove, California, United States, 92845
2
Collaborative Neuroscience Network, LLC
Torrance, California, United States, 90502
3
Hassman Research Institute
Marlton, New Jersey, United States, 08053
4
New York State Psychiatric Institute
New York, New York, United States, 10032