NCT06740383 Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services
| NCT ID | NCT06740383 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | Schizophrenia Spectrum and Other Psychotic Disorders |
| Study Type | OBSERVATIONAL |
| Enrollment | 320 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 320 participants in total. It began in 2023-01-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 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 30 min, history of stroke, AIDS, etc.) * 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: * Pregnant women * Presence of ferromagnetic objects in body * Weight or body size exceeding scanner capacity (\>300 lbs) * Claustrophobia
Contact & Investigator
Matcheri S. Keshavan, MD
PRINCIPAL INVESTIGATOR
Beth Israel Deaconess Medical Center
Frequently Asked Questions
Who can join the NCT06740383 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 40 Years, studying Schizophrenia Spectrum and Other Psychotic Disorders. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06740383 currently recruiting?
Yes, NCT06740383 is actively recruiting participants. Contact the research team at mkeshava@bidmc.harvard.edu for enrollment information.
Where is the NCT06740383 trial being conducted?
This trial is being conducted at Hartford, United States, Athens, United States, Chicago, United States, Belmont, United States and 2 additional locations.
Who is sponsoring the NCT06740383 clinical trial?
NCT06740383 is sponsored by Beth Israel Deaconess Medical Center. The principal investigator is Matcheri S. Keshavan, MD at Beth Israel Deaconess Medical Center. The trial plans to enroll 320 participants.
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