State Representation in Early Psychosis

NCT05273164 | Completed

• 2 other identifiers: STUDY000099645P50MH119569
• Study Type: observational
• Target: 277
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine state representation in individuals aged 15-45 who have been diagnosed with a psychotic illness, as well as young adults who do not have a psychiatric diagnosis. State Representation is our ability to process information about our surroundings. Participants will complete computerized tasks that measure state representation while having their brain activity measured.

Conditions

Psychosis; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Schizoaffective Disorder

Outcome Measures

Primary Outcomes (5)

• Change in Performance of Dot Pattern Expectancy (DPX) Task Variant

  The DPX task variant consists of a series of pattern sequences. One pattern is designated the "A" cue, and another the "X" cue, which requires one response (AX, 60-70% of trials, e.g. respond with the left button), while other sequences require a different response (AY or BX, 12-15% of trials each, or BY, 6-10% of trials, e.g. respond with the right button). Given the strong expectation that X's evokes a valid response, BX trials place demands on the fidelity (stability, memory) of the "B" cue state representation to overcome this tendency. Performance is assessed based on accuracy and response time.

  Baseline, 6 month follow up

• Change in Performance of Bandit Task Variant

  This is a task variant that uses choice options (neutral images) that are rewarded probabilistically. The rewarded stimulus with the highest reward is changed over time. State learning associated with staying or switching stimuli too quickly (lose-switching) can be evaluated. Performance is based on accuracy, response time, and behavior of reward seeking.

  Baseline, 6 month follow up

• Change in Test My Brain Neurocognitive Assessment performance: Global Cognition Z Score.

  The investigators will examine global cognition scores from the Test My Brain neurocognitive battery. Z scores range from -5 to 5, with higher score indicating increased cognitive functioning.

  Baseline, 6 month follow up

• Change in EEG Variables

  Analysis will examine variables including phase synchrony, slope of the spectral power density (indexing E-I balance), and prefrontal/parietal theta as a measure of perceptual noise.

  Baseline, 6 month follow up

• Change in MRI Variables

  MRI assessments will include structural MRI, Diffusion-weighted MRI, Resting State fMRI.

  Baseline, 6 month follow up

Secondary Outcomes (12)

• Change in symptoms and functioning as indicated by Minnesota Symptom Severity Scale

  Baseline,6 month follow up

• Change in symptoms and functioning as indicated by the SANS/SAPS

  Baseline, 6 month follow up

• Change in symptoms and functioning as indicated by the BPRS

  Baseline, 6 month follow up

• Change in symptoms and functioning as indicated by the SPQ-BR

  Baseline, 6 month follow up

• Change in symptoms and functioning as indicated by the SGI

  Baseline, 6 month follow up

Study Arms (2)

Early Psychosis participants

Individuals who have been diagnosed with a psychosis spectrum illness, such as schizophrenia, and are in the early stages of the disease (i.e., aged 15-35, or if 36-45, has had the onset of psychotic symptoms within the last 5 years)

Healthy Controls

Demographically matched participants who do not have a personal or immediate family history of psychosis spectrum illnesses.

Eligibility Criteria

• Age: 15 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants are recruited from Minnesota. Most participants are located in the Twin Cities Metro area.

You may qualify if:

• English proficiency, as determined by staff observation and participant self-report
• Estimated IQ at or above 70, as estimated by the cognitive assessments
• Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, psychosis NOS, bipolar disorder with psychosis, or major depressive disorder with psychosis; those aged 36-45 years old must have had with onset of psychotic symptoms within the previous 5 years
• Achieved clinical stability, defined as outpatient status for at least one month prior to study participation

You may not qualify if:

• Unable or unwilling to provide informed consent
• The participant is unable to demonstrate adequate decisional capacity, in the judgment of the consenting study staff member, to make a choice about participating in the research study
• Participant is pregnant
• Participant is illiterate
• Cannot pass the CMRR Subject Safety Screen due to MRI contraindications
• Presence of a major neurological disorder (psychosis participants may have an autism spectrum diagnosis)
• Previous clinically significant head injury or prolonged unconsciousness, as determined by the PI/Co-Is
• Meets criteria for substance or alcohol dependence within 3 months of enrollment
• The presence of any major medical condition that, in the opinion of the PI/Co-Is, would impede participation in the study or would put the participant at additional risk by participating
• Presence of severe alcohol or substance abuse
• Has participated in significant formal cognitive training programs, as determined by the PI/Co-Is
• Meets criteria for clinical risk of suicidal behavior, as defined by:
• Clinician judgement
• A suicide attempt within 6 months of enrollment
• Active suicidal ideation at screening or baseline, as indicated by the C-SSRS

Sponsors & Collaborators

• University of Minnesota: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Sophia Vinogradov, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Angus MacDonald III, Ph.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Department Head

Study Record Dates

• First Submitted: January 24, 2022
• First Posted: March 10, 2022
• Study Start: December 1, 2021
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available 12 months after the completion of this study.
• Access Criteria: Access will be provided to users who have an account with the NIMH Data Archive and who request permission through a Data Access Request.

Locations

US (1)