NCT05945602

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
29mo left

Started Oct 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Oct 2023Sep 2028

First Submitted

Initial submission to the registry

July 6, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 14, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2028

Last Updated

October 9, 2025

Status Verified

October 1, 2025

Enrollment Period

5 years

First QC Date

July 6, 2023

Last Update Submit

October 6, 2025

Conditions

Schizophrenia Spectrum Disorders

Keywords

SchizophreniaSchizophrenia Spectrum and Other Psychotic DisordeMental Disorders

Outcome Measures

Primary Outcomes (1)

  • 1-week psychometric reliability of Aperiodic Spectral Biomarkers (neurophysiologic biomarker)

    Estimates of aperiodic activity will be calculated from electroencephalography recordings collected at baseline (Day 1) and approximately 7 days later.

    Approximately 7 days

Secondary Outcomes (5)

  • Cognitive training performance

    Day 1/ Baseline

  • Cognition

    Day 1/ Baseline

  • Symptoms

    1 visit

  • Functioning

    Day 1/ Baseline

  • Functioning - Quality of Life

    Day 1/ Baseline

Study Arms (3)

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).

Other: Neurophysiologic Biomarker Assessments

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.

Other: Neurophysiologic Biomarker Assessments

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).

Other: Neurophysiologic Biomarker Assessments

Interventions

Neurophysiologic Biomarker AssessmentsOTHER

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

Biomarker Optimization - Healthy Comparison SubjectsBiomarker Optimization - PatientsBiomarker Validation in Chronic Psychotic Disorders

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Veterans who are enrolled in and/or receiving healthcare services at the VA San Diego Healthcare System.

You may qualify if:

  • 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).
  • Fluent in spoken and written English.
  • No impairment in hearing or vision.

You may not qualify if:

  • 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).
  • History of significant medical or neurological illness or intellectual disability.
  • Inability to comprehend or provide informed consent.
  • Specific to healthy comparison subjects: past or present diagnosis of schizophrenia, schizoaffective disorder, or other chronic psychotic disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Electrophysiological Recordings

MeSH Terms

Conditions

SchizophreniaMental Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Study Officials

  • Juan Molina, MD

    VA San Diego Healthcare System, San Diego, CA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Juan Molina, MD

CONTACT

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

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 6, 2023

First Posted

July 14, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

September 30, 2028

Study Completion (Estimated)

September 30, 2028

Last Updated

October 9, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)