The Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services (BICEPS) study aims to understand the early stages of psychotic disorders like Schizophrenia, Schizoaffective Disorder, and Bipolar I Disorder. It involves gathering mental health information, brain scans (MRI), eye movement patterns (Eye-Tracking), and brain electrical waves (EEG) data from individuals who have experienced these disorders in recent years. Participants will be involved for about a year, with four visits over this period. Screening procedures, lasting approximately 3 hours, include tests for drug use, a pregnancy test for eligible women, clinical interviews about feelings and experiences, psychiatric and family history interviews, and a medical history review. Research procedures for eligible participants include DNA collection, a neuropsychological test battery, EEG, eye-tracking, and MRI. These procedures will help researchers understand brain function, genetics, and cognitive abilities related to psychotic disorders. Follow-up visits at 1-month, 6-month, and 12-month intervals involve modified clinical interviews and repeating neuropsychological tests to track changes over time. Participants may opt to provide DNA samples for genetic analysis, undergo various cognitive tests, EEG to record brain waves, eye-tracking to monitor eye movements, and MRI scans to visualize brain structure. Follow-up visits at regular intervals will help researchers track changes in symptoms and cognitive function. This study provides comprehensive insight into the onset and progression of psychotic disorders and offers valuable information for patients, families, and healthcare providers involved in managing these conditions. Our goal is to better understand whether a combination of biological markers and different types of people (BT1, BT2, BT3) can help us predict how well individuals with early psychosis respond to specialized care. We expect that those in BT3 will have the best outcomes, BT2 will have intermediate outcomes, and BT1 will have the poorest outcomes. Even though BT1 and BT2 might start with similar cognitive issues, their biology might lead to different responses to treatment. This research can help us understand which treatments work best for different people with early psychosis.
Males and females, all races and ethnicities
18-40 y/o
Meet DSM-5 criteria for a psychotic disorder, i.e. schizophrenia, schizophreniform, schizoaffective disorder, or bipolar I disorder or major depression with psychotic features, delusional disorder or psychosis N.O.S.
Able to read, speak, and understand English
Estimated premorbid intellectual ability <70 (WRAT-4, Word Reading subtest, age-corrected standardized score)
Neurological or medical disorder that may affect brain function (seizure disorder, traumatic brain injury with a loss of consciousness greater than or equal to 30 min, history of stroke, AIDS, etc.)
Psychoses secondary to substance use i.e., Comorbid DSM-5 diagnosis of alcohol or substance use disorders that may explain the diagnosis of psychotic disorders (individuals with cannabis use disorders unrelated to psychosis onset will be allowed. Participants encouraged to abstain from substances for 24 hours prior to lab visits)
Pregnant women
Participants are recruited from 5 different sites across the United States including Boston, Dallas, Hartford, Chicago, and Georgia. The target population for this study includes individuals who meet DSM-5 criteria for a psychotic disorder (i.e., schizophrenia, schizophreniform, schizoaffective disorder, bipolar I disorder or major depression with psychotic features, delusional disorder, or psychosis N.O.S.). Participants will be between 18 and 40 years of age, males and females, of all races and ethnicities who are experiencing early course psychosis.
Cohort
Prospective
Not listed
Treatment Response
\>30% reduction in Positive and Negative Syndrome Scale (PANSS) score
Symptomatic Remission
Score of ≤ 3 on 8 core on the Positive and Negative Syndrome Scale (PANSS) items (P1, P2, P3, 1, N4, N6, N7, G5, and G9) for at least one month
Functional Remission
Score ≥ 7 on Global Functioning Role and Social Scales
Relapse
1\) Positive and Negative Syndrome Scale (PANSS) score of ≥ 4 for a psychosis item (P1, P2, P3, and P6) and ≥ 25% increase on the total PANSS score or ≥ 10 points and 2) an increased level of care, i.e. hospitalization, ER visits, etc.
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Beth Israel Deaconess Medical Center
Lead sponsor
University of Chicago
Collaborator
University of Texas Southwestern Medical Center
Collaborator
Yale University
Collaborator
Hartford Hospital
Collaborator
University of Georgia
Collaborator
Mclean Hospital
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
