Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

Status: Recruiting
Location: See all (6) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: f
View:

• Males and females, all races and ethnicities

• 18-35 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

• Able and willing to provide written informed consent, and willing to commit to the study protocol

• Illness duration from psychosis onset less than or equal to 3 years

Locations
United States
Connecticut
Hartford Hospital
RECRUITING
Hartford
Georgia
University of Georgia
RECRUITING
Athens
Illinois
University of Chicago Medical Center
RECRUITING
Chicago
Massachusetts
McLean Hospital
RECRUITING
Belmont
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Matcheri S. Keshavan, MD
mkeshava@bidmc.harvard.edu
617-754-1256
Backup
Kareem F. Hamada, MS
khamada@bidmc.harvard.edu
617-652-0858
Time Frame
Start Date: 2023-01-01
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 320
Treatments
Individuals with Early Psychosis enrolled in Coordinated Specialty Care Clinics
In this naturalistic longitudinal study, we administer the B-SNIP biomarker batter to individuals with Early Psychosis (EP) in EP clinics with Coordinated Specialty Care treatment programs to characterize outcome trajectories and biotypes. EP individuals of both sexes, age 18-35 will be included after they meet study criteria and provide informed consent. Individuals with psychosis duration \< 3 years will be included. Individuals in this cohort of EP are diagnosed with Schizophrenia, Schizoaffective Disorder, Schizophreniform, Bipolar I Disorder with psychotic features, Delusional Disorder, Major Depressive Disorder with psychotic features, and Psychosis Not Otherwise Specified.
Related Therapeutic Areas
Sponsors
Collaborators: Yale University, Hartford Hospital, National Institute of Mental Health (NIMH), University of Georgia, University of Chicago, University of Texas Southwestern Medical Center, Mclean Hospital
Leads: Beth Israel Deaconess Medical Center

This content was sourced from clinicaltrials.gov