Recruiting

Neurophysiologic Biomarkers

Sponsor:

VA Office of Research and Development

Code:

NCT05945602

Conditions

Schizophrenia Spectrum Disorders

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Neurophysiologic Biomarker Assessments

Study Details

Brief summary:

Cognitive symptoms of schizophrenia interfere with daily life-from managing self-care, to more complex tasks like taking medications and living independently. Unfortunately, these cognitive symptoms are not corrected by 'standard of care' treatments (antipsychotic medications), although some schizophrenia patients may experience modest clinical and cognitive benefits from cognitive remediation. To enhance the clinical impact of cognitive remediation and other rehabilitative interventions for Veterans living with chronic psychosis, this study will develop novel brain-based tools to help identify those Veterans who are most likely to benefit from pro-cognitive therapies. These studies may advance predictive algorithms that improve functional outcomes and life quality in Veterans with schizophrenia.

Conditions

Schizophrenia Spectrum Disorders

Study ID

NCT05945602

Start date

Oct 1, 2023

Status verified date

Oct, 2025

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Have a DSM-5 diagnosis of a chronic psychotic disorder (e.g., schizophrenia, schizoaffective disorder, or delusional disorder); or b) are in good general mental and physical health (i.e., no active mental health condition).
2. Fluent in spoken and written English.
3. No impairment in hearing or vision.

Exclusion Criteria:

1. Active substance other than cannabis within the last 30 days as determined by self-report or positive urine toxicology (obtained as part of the screening process).
2. History of significant medical or neurological illness or intellectual disability.
3. Inability to comprehend or provide informed consent.
4. Specific to healthy comparison subjects: past or present diagnosis of schizophrenia, schizoaffective disorder, or other chronic psychotic disorder.

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Biomarker Optimization - Patients

Veterans currently enrolled for healthcare services at the VA San Diego Healthcare System who have a diagnosis of a chronic psychotic disorder (e.g., schizophrenia or schizoaffective disorder).

Biomarker Optimization - Healthy Comparison Subjects

Veterans currently enrolled for healthcare services at the VA San Diego Healthcare System who have no history of mental illness.

Biomarker Validation in Chronic Psychotic Disorders

Veterans currently enrolled for healthcare services at the VA San Diego Healthcare System with a diagnosis of a chronic psychotic disorder (e.g., schizophrenia or schizoaffective disorder).

Interventions

Neurophysiologic Biomarker Assessments

Non-invasive electroencephalography will be recorded to derive neurophysiologic biomarkers.

Primary outcome measure

  • 1-week psychometric reliability of Aperiodic Spectral Biomarkers (neurophysiologic biomarker) [ Time Frame: Approximately 7 days ]

Central Contacts and Locations

Central contacts

Juan Molina, MD

(202) 555-8975Juan.Molina@va.gov

Locations

VA San Diego Healthcare System, San Diego, CA

Recruiting

San Diego, California, United States, 92161-0002

Contacts

Juan Molina, MD

(202) 555-8975Juan.Molina@va.gov

Principal Investigator:

Juan Molina, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Oct 9, 2025

Last verified

Oct, 2025

Keywords

  • Schizophrenia
  • Schizophrenia Spectrum and Other Psychotic Disorde
  • Mental Disorders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-10-09.