Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

Condition(s) studied

Study summary

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.

Eligibility

Primary outcome measure(s)

• Treatment Response — From enrollment at baseline to end of study at 1 year
  \>30% reduction in Positive and Negative Syndrome Scale (PANSS) score
• Symptomatic Remission — From enrollment at baseline to end of study at 1 year
  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 — From enrollment at baseline to end of study at 1 year
  Score ≥ 7 on Global Functioning Role and Social Scales
• Relapse — From enrollment at baseline to end of study at 1 year
  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.

Trial sites (6)

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