Examining state representation in early psychosis
State Representation in Early Psychosis
This study is trying to see how young people aged 15-45 with early psychosis understand their surroundings compared to others their age without mental health issues, while also looking at how brain activity relates to their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 350 (estimated) |
| Ages | 15 Years to 45 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05273164 on ClinicalTrials.gov |
What this trial studies
This study investigates how individuals aged 15-45 with psychotic illnesses process information about their surroundings compared to demographically similar young adults without psychiatric diagnoses. Participants will undergo a series of assessments, including interviews, self-report questionnaires, and neurocognitive evaluations, over two sets of appointments spaced six months apart. Additionally, they will participate in simultaneous EEG and fMRI imaging while performing computerized tasks to explore the relationship between neural circuits and clinical symptoms in early psychosis. The goal is to understand the clinical heterogeneity in early psychosis and how cognitive training may influence state representation.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 15-45 with a clinical diagnosis of schizophrenia or related disorders who have achieved clinical stability.
Not a fit: Patients who are unable to provide informed consent or demonstrate adequate decisional capacity may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of cognitive processes in early psychosis, potentially leading to improved interventions and outcomes for patients.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in understanding cognitive processes in psychosis, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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 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 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 * 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 Additional Exclusion Criteria for Early Psychosis Participants: * 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 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Sophia Vinogradov, MD — University of Minnesota
- Study coordinator: Connor Petricek, BA
- Email: Stepstudy@umn.edu
- Phone: 612-741-2826
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.