Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services
Launched by BETH ISRAEL DEACONESS MEDICAL CENTER · Dec 13, 2024
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
The BICEPS study is a research project designed to better understand the early stages of psychotic disorders, such as schizophrenia, schizoaffective disorder, and bipolar I disorder. Researchers will collect various types of information, including brain scans, eye movement patterns, and brain wave activity, from individuals who have experienced these conditions within the last three years. This study aims to explore how different biological markers and individual characteristics can help predict how well people respond to specialized treatments. Participants will take part in the study for about a year, attending four visits during which they will undergo interviews, cognitive tests, and other assessments to track changes in their symptoms and cognitive abilities.
To be eligible for the study, participants should be between 18 and 35 years old and diagnosed with a psychotic disorder. It's important that they can read and understand English and are willing to commit to the study's requirements. During the study, participants will have the opportunity to provide DNA samples, undergo brain scans, and complete various tests to help researchers learn more about how these disorders develop and how to improve treatment options. This research is a valuable step forward in understanding psychotic disorders and tailoring care to meet the needs of different individuals.
Gender
ALL
Eligibility criteria
- 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
About Beth Israel Deaconess Medical Center
Beth Israel Deaconess Medical Center (BIDMC) is a leading academic medical center located in Boston, Massachusetts, affiliated with Harvard Medical School. Renowned for its commitment to cutting-edge research and innovation in healthcare, BIDMC fosters a collaborative environment that integrates patient care, education, and scientific investigation. The center actively sponsors clinical trials across a variety of disciplines, aiming to advance medical knowledge and improve patient outcomes. With a focus on translational medicine, BIDMC's research initiatives engage multidisciplinary teams to address complex health challenges and translate findings into effective therapeutic strategies.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Belmont, Massachusetts, United States
Hartford, Connecticut, United States
Dallas, Texas, United States
Chicago, Illinois, United States
Athens, Georgia, United States
Boston, Massachusetts, United States
Patients applied
Trial Officials
Matcheri S. Keshavan, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported