Actively Recruiting

Age: 18Years - 40Years
All Genders
NCT06740383

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

Led by Beth Israel Deaconess Medical Center · Updated on 2026-03-10

320

Participants Needed

6

Research Sites

234 weeks

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

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.

CONDITIONS

Official Title

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

Who Can Participate

Age: 18Years - 40Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Males and females of all races and ethnicities
  • Age 18 to 40 years
  • Meet DSM-5 criteria for a psychotic disorder including 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
  • Able and willing to provide written informed consent and follow the study protocol
  • Psychosis illness duration less than or equal to 4 years
  • Receiving both psychopharmacology and psychotherapy at baseline only
Not Eligible

You will not qualify if you...

  • Premorbid intellectual ability estimated below 70 on WRAT-4 Word Reading subtest
  • Neurological or medical conditions affecting brain function such as seizure disorder, traumatic brain injury with loss of consciousness of 30 minutes or more, stroke, or AIDS
  • Psychosis caused by substance use disorders (except cannabis use disorders unrelated to psychosis onset)
  • Pregnant women
  • Presence of ferromagnetic objects in the body
  • Weight or body size exceeding MRI scanner capacity (over 300 lbs)
  • Claustrophobia preventing MRI scanning

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

Actively Recruiting

3

University of Chicago Medical Center

Chicago, Illinois, United States, 60637

Actively Recruiting

4

McLean Hospital

Belmont, Massachusetts, United States, 02478

Actively Recruiting

5

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States, 02215-5400

Actively Recruiting

6

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

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Research Team

M

Matcheri S. Keshavan, MD

CONTACT

B

Brendan Stiltner, BA

CONTACT

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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