Understanding early psychosis and its biological markers
Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services
This study is trying to find out more about early signs of psychotic disorders like schizophrenia and bipolar disorder by looking at brain scans and other health data from around 320 participants over a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 320 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center Academic / other |
| Locations | 6 sites (Hartford, Connecticut and 5 other locations) |
| Trial ID | NCT06740383 on ClinicalTrials.gov |
What this trial studies
The BICEPS study aims to explore the early stages of psychotic disorders such as Schizophrenia and Bipolar I Disorder by collecting mental health data, brain scans, eye movement patterns, and EEG data from participants. Over the course of a year, individuals will attend four visits where they will undergo various assessments, including clinical interviews and neuropsychological tests. The study seeks to identify clinical and biological predictors of outcomes in early psychosis, which could enhance treatment planning and intervention strategies. This multi-site study will involve approximately 320 participants across several institutions, coordinated by Boston's Beth Israel Deaconess Medical Center.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 18-35 who have experienced the onset of a psychotic disorder within the last three years.
Not a fit: Patients with significant neurological disorders or those with recent substance use disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies tailored to individual patients with early psychosis.
How similar studies have performed: Other studies have shown promise in using biomarkers to predict outcomes in psychotic disorders, but this approach is still evolving.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hartford, Connecticut and 5 other locations
- Hartford Hospital — Hartford, Connecticut, United States (Recruiting)
- University of Georgia — Athens, Georgia, United States (Recruiting)
- University of Chicago Medical Center — Chicago, Illinois, United States (Recruiting)
- McLean Hospital — Belmont, Massachusetts, United States (Recruiting)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (Recruiting)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Matcheri S. Keshavan, MD — Beth Israel Deaconess Medical Center
- Study coordinator: Matcheri S. Keshavan, MD
- Email: mkeshava@bidmc.harvard.edu
- Phone: 617-754-1256
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.