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
- Diseases
- Schizophrenia, Depression, Bipolar disorder
- 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
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Georgia Coordinator of this site? Confirm its status | Athens | United States | Recruiting |
| McLean Hospital Coordinator of this site? Confirm its status | Belmont | United States | Recruiting |
| Beth Israel Deaconess Medical Center Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
| University of Chicago Medical Center Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Hartford Hospital Coordinator of this site? Confirm its status | Hartford | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.