Status:
COMPLETED
State Representation in Early Psychosis
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Psychosis
Schizophrenia
Eligibility:
All Genders
15-45 years
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...
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Key Trial Info
Start Date :
December 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 29 2025
Estimated Enrollment :
277 Patients enrolled
Trial Details
Trial ID
NCT05273164
Start Date
December 1 2021
End Date
August 29 2025
Last Update
September 22 2025
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55454