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Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

RECRUITINGSponsored by Beth Israel Deaconess Medical Center
Actively Recruiting
SponsorBeth Israel Deaconess Medical Center
Started2023-01-01
Est. completion2027-06-30
Eligibility
Age18 Years – 35 Years
Healthy vol.Accepted
Locations6 sites

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

Age: 18 Years – 35 YearsHealthy volunteers accepted
Inclusion Criteria:

* 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

Exclusion Criteria:

* Estimated premorbid intellectual ability \<70 (WRAT-4, Word Reading subtest, age-corrected standardized score)
* Neurological or medical disorder that may affect brain function (seizure disorder, traumatic brain injury with a loss of consciousness greater than or equal to 3o min, history of stroke, AIDS, etc.)
* Comorbid DSM-5 diagnosis of alcohol or substance use disorders in prior 3 months (cases with cannabis use not meeting criteria for cannabis use disorder will be allowed).

MRI-Specific Exclusion Criteria:

* Pregnant women
* Presence of ferromagnetic objects in body
* Weight or body size exceeding scanner capacity (\>300 lbs)
* Claustrophobia

Conditions8

Bipolar 1 DisorderDelusional DisorderDepressionEarly PsychosisPsychosis Not Otherwise SpecifiedSchizoaffective DisorderSchizophreniaSchizophrenia Spectrum and Other Psychotic Disorders

Locations6 sites

Hartford Hospital
Hartford, Connecticut, 06102
Godfrey Pearlson, MA, MBBS860.545.7757Godfrey.Pearlson@HHChealth.org
University of Georgia
Athens, Georgia, 30602
Brett Clementz, PhD706-542-2174clementz@uga.edu
University of Chicago Medical Center
Chicago, Illinois, 60637
Sarah K. Keedy, PhD773-834-7178skeedy@bsd.uchicago.edu
McLean Hospital
Belmont, Massachusetts, 02478
Kathryn E. Lewandowski, PhD617-855-2886klewanowski@mclean.harvard.edu
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215-5400
Matcheri S. Keshavan, MD617-754-1256mkeshava@bidmc.harvard.edu

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