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Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services Observational Study of Early Psychosis with Coordinated Specialty Care
Led by Beth Israel Deaconess Medical Center · Updated on 2026-03-10
320
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
Sponsors
B
Beth Israel Deaconess Medical Center
Lead Sponsor
U
University of Chicago
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the early stages of psychotic disorders such as Schizophrenia, Schizoaffective Disorder, and Bipolar I Disorder to better understand their progression and how biological markers and different patient types may predict treatment response. This observational study involves a large sample across multiple sites, aiming to identify clinical and biological predictors of outcomes to improve personalized care for individuals with early psychosis. Participants receive coordinated specialty care and undergo a series of assessments including brain scans (MRI), eye-tracking, EEG, DNA collection, and neuropsychological testing at baseline and follow-up visits at 1, 6, and 12 months. These procedures help gather data on brain function, genetics, and cognitive abilities. The study categorizes participants into biotypes based on biomarker profiles to explore their relation to treatment outcomes. Participants are involved for about one year, attending four visits where clinical interviews, cognitive tests, and biomarker assessments are conducted. Screening takes about three hours and includes drug and pregnancy testing, psychiatric and medical history reviews. Researchers track outcomes such as treatment response, symptomatic and functional remission, and relapse over the study period to gain insight into early psychosis and guide future care strategies.
CONDITIONS
Brief Title
Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females, all races and ethnicities
- Age 18 to 40 years
- Diagnosed with a psychotic disorder such as schizophrenia, schizophreniform, schizoaffective disorder, bipolar I disorder, major depression with psychotic features, delusional disorder, or psychosis not otherwise specified
- Able to read, speak, and understand English
- Willing and able to provide informed consent and follow the study protocol
- Illness duration from psychosis onset 4 years or less
- Receiving both psychopharmacology and psychotherapy at baseline only
You will not qualify if you...
- Estimated premorbid intellectual ability below 70 on WRAT-4 Word Reading subtest
- Neurological or medical disorders affecting brain function such as seizure disorder, significant traumatic brain injury, stroke, or AIDS
- Psychoses caused by substance use disorders (except cannabis use disorder unrelated to psychosis onset)
- Pregnant women (for MRI scans)
- Presence of ferromagnetic objects in the body preventing MRI
- Weight or body size exceeding MRI scanner capacity (over 300 lbs)
- Claustrophobia preventing MRI scans
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants with early psychosis enrolled in Coordinated Specialty Care Clinics are observed and assessed over time with biomarker and clinical evaluations to characterize outcome trajectories.
Visits at baseline, 1 month, 6 months, and 12 months
Trial Site Locations
Total: 6 locations
1
Hartford Hospital
Hartford, Connecticut, United States, 06102
Actively Recruiting
2
University of Georgia
Athens, Georgia, United States, 30602
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3
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
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4
McLean Hospital
Belmont, Massachusetts, United States, 02478
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5
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215-5400
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6
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
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Research Team
M
Matcheri S. Keshavan, MD
B
Brendan Stiltner, BA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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