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NCT06740383Recruiting

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

Source: ClinicalTrials.gov · Last updated 10 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
320 (estimated)
First submitted
13 Dec 2024
Start date
1 Jan 2023
Primary completion date
30 Jun 2027
Lead sponsor
Beth Israel Deaconess Medical Center
NCT number
NCT06740383

What you commit to

  • Study type: Observational
  • Planned participants: 320
  • From 1 Jan 2023 to the primary completion date, 30 Jun 2027
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Psychoses secondary to substance use i.e., Comorbid DSM-5 diagnosis of alcohol or substance use disorders that may explain the diagnosis of psychotic disorders (individuals with cannabis use disorders unrelated to psychosis onset will be allowed. Participants encouraged to abstain from substances for 24 hours prior to lab visits)
    • MRI-Specific Exclusion Criteria:

Other illness

  • Neurological or medical disorder that may affect brain function (seizure disorder, traumatic brain injury with a loss of consciousness greater than or equal to 30 min, history of stroke, AIDS, etc.)

Age

  • Estimated premorbid intellectual ability \<70 (WRAT-4, Word Reading subtest, age-corrected standardized score)

Other

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

Who the study is looking for

  • Males and females, all races and ethnicities
  • 18-40 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 4 years
  • At baseline only: receiving both psychopharmacology and psychotherapy

Age in the registry: 18 years to 40 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
University of Georgia
Coordinator of this site? Confirm its status
AthensUnited StatesRecruiting
McLean Hospital
Coordinator of this site? Confirm its status
BelmontUnited StatesRecruiting
Beth Israel Deaconess Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesRecruiting
University of Chicago Medical Center
Coordinator of this site? Confirm its status
ChicagoUnited StatesRecruiting
University of Texas Southwestern Medical Center
Coordinator of this site? Confirm its status
DallasUnited StatesRecruiting
Hartford Hospital
Coordinator of this site? Confirm its status
HartfordUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.