RecruitingNCT06740383

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services


Sponsor

Beth Israel Deaconess Medical Center

Enrollment

320 participants

Start Date

Jan 1, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study tracks people in the early stages of a psychotic disorder to understand what biological markers and treatment patterns predict long-term outcomes. It aims to identify subtypes of early psychosis to help tailor future treatments more effectively. **You may be eligible if...** - You are between 18 and 40 years old - You have been diagnosed within the past 4 years with schizophrenia, bipolar disorder with psychotic features, major depression with psychosis, or a related psychotic disorder (DSM-5 criteria) - You are able to read, speak, and understand English - You are currently receiving both medication and psychotherapy **You may NOT be eligible if...** - Your psychotic illness began more than 4 years ago - You are not currently engaged in both pharmacological and psychotherapy treatment - You have conditions that prevent safe participation in the study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(6)

Hartford Hospital

Hartford, Connecticut, United States

University of Georgia

Athens, Georgia, United States

University of Chicago Medical Center

Chicago, Illinois, United States

McLean Hospital

Belmont, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06740383


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