State Representation in Early Psychosis

NCT ID: NCT05273164

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 277 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-08-29

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.

Detailed Description

Participants will be asked to complete two sets of appointments six months apart. During both sets of appointments, participants will be asked to complete interviews examining behaviors and symptoms of mental health conditions, self-report questionnaires, and a neurocognitive assessment. In addition, participants will complete an imaging appointment, in which they will receive simultaneous electroencephalography (EEG) and functional Magnetic Resonance Imaging (fMRI) while performing two computerized tasks.

The purpose of this study is to determine how differences in information processing that support state representation in neural circuits relate to clinical heterogeneity in early psychosis. To this end, the investigators will: (a) Recruit people with early psychosis and demographically similar adults without a psychiatric illness aged 15-45 years; (b) Determine test-retest reliability of variants of the Dot Pattern Expectancy (DPX) and Bandit tasks as assessments of state representation processes; (c) Characterize behavioral performance and neurophysiology at baseline using the DPX and Bandit task variants during simultaneous EEG-fMRI along with other MRI modalities; (d) Follow patients for 6 months while they receive usual care, to delineate their clinical trajectories; (e) Repeat the behavioral and EEG-fMRI assessments after six months. The data the investigators acquire will allow us to examine the baseline relationships between clinical and experimental measures, and also to investigate how changes in clinical and experimental measures are related over a 6-month time period during a critical phase of illness.

Participants in this protocol will be invited to participate in a follow on study, NCT05664594.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

No interventions assigned to this group

Healthy Controls

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

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Previous intent to act on suicidal ideation with a specific plan and/or preparatory acts within 6 months of enrollment, as indicated by the C-SSRS

• Meets DSM-5 criteria for psychotic, bipolar, or autism spectrum disorder
• Has a family history (1st degree relative) of psychotic, bipolar, or autism spectrum disorder

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Sophia Vinogradov

Professor and Department Head

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sophia Vinogradov, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Angus MacDonald III, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

5P50MH119569

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00009964

Identifier Type: -

Identifier Source: org_study_id