Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT05664594
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; participants aged 36-45 must have onset of psychosis within the past 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 patients may have a diagnosis of autism spectrum 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
* 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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
45 Years
Study:
NCT05664594
Study Brief:
Protocol Section:
NCT05664594