ClinConnect ClinConnect Logo
Search / Trial NCT06740383

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

Schizophrenia Bipolar Disorder Schizoaffective Disorder Schizophreniform Major Depression Psychosis Delusional Disorder Biotypes Biomarkers Coordinated Specialty Care

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.

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

0 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