Eligibility Details:
- 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.
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
