PsychosisSTEPNCT05273164
State Representation in Early Psychosis
An observational study of Psychosis and Schizophrenia, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychosis, Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders
- How many people
- 277 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 29 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Participants are recruited from Minnesota. Most participants are located in the Twin Cities Metro area.
Who may be able to join
- English proficiency, as determined by staff observation and participant self-report
- Estimated IQ at or above 70, as estimated by the cognitive assessments
- Additional Inclusion Criteria for Early Psychosis Participants:
- 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
Who cannot join
- 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)
Show all 20Show fewer
- 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
- Additional Exclusion Criteria for Early Psychosis Participants:
- 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
- Additional Exclusion Criteria for Control Participants:
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
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.
Read the 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
- Medical subject headings
- Psychotic Disorders, Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 month follow up
Change in MRI Variables
MRI assessments will include structural MRI, Diffusion-weighted MRI, Resting State fMRI.
Measured: Baseline, 6 month follow up
Secondary outcomes (12)
Change in symptoms and functioning as indicated by Minnesota Symptom Severity Scale
This 29-item measure assesses symptoms in several domains such as anxiety, depression, sleep problems, somatic symptoms, and substance use. Scores range from 0 to 116, with a higher score indicating greater symptom severity.
Measured: Baseline,6 month follow up
Change in symptoms and functioning as indicated by the SANS/SAPS
The Scale for Assessment of Negative Symptoms (SANS, 25 items) and Scale for Assessment of Positive Symptoms (SAPS, 34 items) assess negative and positive symptoms of schizophrenia in a standardized interview. Scores on the SANS ranges from 0-125, and the SANS ranges from 0-170, with higher scores indicating increased symptom severity.
Measured: Baseline, 6 month follow up
Change in symptoms and functioning as indicated by the BPRS
The Brief Psychiatric Rating Scale is a 24-item interview which assesses psychiatric symptoms. Scores on the BPRS rang from 24-168, with a higher score indicating increased symptom severity.
Measured: Baseline, 6 month follow up
Change in symptoms and functioning as indicated by the SPQ-BR
Schizotypal Personality Questionnaire Brief Revised, a 32-item measure to assess a broad array of schizotypal symptoms and signs. The SPQ ranges from 32-160, with a higher score indicating greater schizotypy.
Measured: Baseline, 6 month follow up
Change in symptoms and functioning as indicated by the SGI
The Sensory Gating Inventory Brief is a 10-item measure assesses an individual's subjective ability to modulate, filter, over-include, discriminate, attend to, and tolerate sensory stimuli. The SGI ranges from 10-60, with higher score indicating increased perceptual abnormalities.
Measured: Baseline, 6 month follow up
Change in symptoms and functioning as indicated by the IDI
The Intersectional Discrimination Index is a 31-item measure assesses anticipated, day to day, and major discrimination experienced by the participant. Scores range from 0-136, with higher scores indicating greater discrimination experienced by the individual.
Measured: Baseline, 6 month follow up
Change in symptoms and functioning as indicated by the WHODAS 2.0 Brief
The World Health Organization Disability Assessment Schedule is a 12-item self-administered scale measuring disability and functional impairment. The WHODAS ranges in score from 12-60, with a higher score indicating increased disability.
Measured: Baseline, 6 month follow up
Change in symptoms and functioning as indicated by the GFS/GFR
The Global Functioning Social/Global Functioning Role scales provide a rating on a scale from 1-10 for social functioning and for role functioning, with higher scores indicating increased functioning.
Measured: Baseline, 6 month follow up
Change in Test My Brain Neurocognitive Assessment performance: Digit Symbol Matching Z Score
This subdomain of the TMB battery assesses processing speed. Z scores range from -5 to 5, with higher score indicating increased functioning.
Measured: Baseline, 6 month follow up
Change in Test My Brain Neurocognitive Assessment performance: Verbal Pair Associates Memory Z Score
This subdomain of the TMB battery assesses verbal learning. Z scores range from -5 to 5, with higher score indicating increased functioning.
Measured: Baseline, 6 month follow up
Change in Test My Brain Neurocognitive Assessment performance: Matrix Reasoning Z Score
This subdomain of the TMB battery assesses reasoning skills and also provides an IQ estimate. Z scores range from -5 to 5, with higher score indicating increased functioning.
Measured: Baseline, 6 month follow up
Change in Test My Brain Neurocognitive Assessment performance: Multiracial Emotion Identification Z Score
This subdomain of the TMB battery is a social cognition test that assesses the ability to recognize emotions (happiness, sadness, anger, and fear). Z scores range from -5 to 5, with higher score indicating increased functioning.
Measured: Baseline, 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2022
- Study start1 Dec 2021
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 277 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Sophia Vinogradov, University of Minnesota
- Investigators
- Sophia Vinogradov, MD, Principal investigator, University of MinnesotaAngus MacDonald III, Ph.D., Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05273164
- Sponsor's protocol ID
- STUDY00009964
- Other IDs
- 5P50MH119569
- Acronym
- STEP
- Status last verified
- Sep 2025
- First submitted
- 24 Jan 2022
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This data is shared with the NIMH Data Archive, Collection ID C3504, and will include demographics, imaging data, and primary and secondary outcome data.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- State Representation in Early Psychosis
- ClinicalTrials.gov ID
- NCT05273164
- Acronym / sponsor ID
- STEP / STUDY00009964
- Conditions
- Psychosis, Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Schizoaffective Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 277 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 10 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 15 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Participants are recruited from Minnesota. Most participants are located in the Twin Cities Metro area.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Performance of Dot Pattern Expectancy (DPX) Task Variant
Time frame: Baseline, 6 month follow up
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.
Change in Performance of Bandit Task Variant
Time frame: Baseline, 6 month follow up
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.
Change in Test My Brain Neurocognitive Assessment performance: Global Cognition Z Score.
Time frame: Baseline, 6 month follow up
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.
Change in EEG Variables
Time frame: Baseline, 6 month follow up
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.
Change in MRI Variables
Time frame: Baseline, 6 month follow up
MRI assessments will include structural MRI, Diffusion-weighted MRI, Resting State fMRI.
12 secondary outcomes
Change in symptoms and functioning as indicated by Minnesota Symptom Severity Scale
Time frame: Baseline,6 month follow up
Change in symptoms and functioning as indicated by the SANS/SAPS
Time frame: Baseline, 6 month follow up
Change in symptoms and functioning as indicated by the BPRS
Time frame: Baseline, 6 month follow up
Change in symptoms and functioning as indicated by the SPQ-BR
Time frame: Baseline, 6 month follow up
Change in symptoms and functioning as indicated by the SGI
Time frame: Baseline, 6 month follow up
Change in symptoms and functioning as indicated by the IDI
Time frame: Baseline, 6 month follow up
Change in symptoms and functioning as indicated by the WHODAS 2.0 Brief
Time frame: Baseline, 6 month follow up
Change in symptoms and functioning as indicated by the GFS/GFR
Time frame: Baseline, 6 month follow up
Change in Test My Brain Neurocognitive Assessment performance: Digit Symbol Matching Z Score
Time frame: Baseline, 6 month follow up
Change in Test My Brain Neurocognitive Assessment performance: Verbal Pair Associates Memory Z Score
Time frame: Baseline, 6 month follow up
Change in Test My Brain Neurocognitive Assessment performance: Matrix Reasoning Z Score
Time frame: Baseline, 6 month follow up
Change in Test My Brain Neurocognitive Assessment performance: Multiracial Emotion Identification Z Score
Time frame: Baseline, 6 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: Yes. This data is shared with the NIMH Data Archive, Collection ID C3504, and will include demographics, imaging data, and primary and secondary outcome data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sophia Vinogradov, MD principal investigator
University of Minnesota
Angus MacDonald III, Ph.D. principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psychosis and Schizophrenia, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Performance of Dot Pattern Expectancy (DPX) Task Variant (time frame: Baseline, 6 month follow up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.