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Search / Trial NCT05273164

State Representation in Early Psychosis

Launched by UNIVERSITY OF MINNESOTA · Feb 28, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial, titled "State Representation in Early Psychosis," is exploring how people aged 15 to 45 with psychotic illnesses, like schizophrenia or schizoaffective disorder, understand and process information about their environment. The study will also include young adults without any psychiatric diagnosis for comparison. Participants will undergo various observational tests and take part in cognitive training to see how well they can represent their surroundings. The goal is to learn more about how these conditions affect thinking and perception.

To be eligible for this study, participants must speak English and have an estimated IQ of 70 or higher. Individuals diagnosed with specific psychotic disorders must have been stable in their treatment for at least a month before joining. However, those who are pregnant, unable to provide consent, or have certain medical conditions will not be able to participate. If you join the study, you can expect to take part in tests that help researchers understand your thinking processes better, and your insights could contribute to improving care for those with psychotic disorders.

Gender

ALL

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
  • 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

About University Of Minnesota

The University of Minnesota is a leading academic institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. With a focus on interdisciplinary collaboration, the university leverages its extensive resources and expertise to conduct cutting-edge studies aimed at improving patient outcomes and addressing critical health challenges. Its robust clinical trial program emphasizes ethical standards, patient safety, and scientific rigor, contributing to the development of novel therapies and interventions that enhance medical practice and public health.

Locations

Minneapolis, Minnesota, United States

Patients applied

0 patients applied

Trial Officials

Sophia Vinogradov, MD

Principal Investigator

University of Minnesota

Angus MacDonald III, Ph.D.

Principal Investigator

University of Minnesota

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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