RECRUITING

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

Quick Facts

Study Start:2023-01-01
Study Completion:2027-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06740383

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 35 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Males and females, all races and ethnicities
  2. * 18-35 y/o
  3. * 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.
  4. * Able to read, speak, and understand English
  5. * Able and willing to provide written informed consent, and willing to commit to the study protocol
  6. * Illness duration from psychosis onset less than or equal to 3 years
  1. * Estimated premorbid intellectual ability \<70 (WRAT-4, Word Reading subtest, age-corrected standardized score)
  2. * 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.)
  3. * 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).

Contacts and Locations

Study Contact

Matcheri S. Keshavan, MD
CONTACT
617-754-1256
mkeshava@bidmc.harvard.edu
Kareem F. Hamada, MS
CONTACT
617-652-0858
khamada@bidmc.harvard.edu

Principal Investigator

Matcheri S. Keshavan, MD
PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center

Study Locations (Sites)

Hartford Hospital
Hartford, Connecticut, 06102
United States
University of Georgia
Athens, Georgia, 30602
United States
University of Chicago Medical Center
Chicago, Illinois, 60637
United States
McLean Hospital
Belmont, Massachusetts, 02478
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215-5400
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

  • Matcheri S. Keshavan, MD, PRINCIPAL_INVESTIGATOR, Beth Israel Deaconess Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01
Study Completion Date2027-06-30

Study Record Updates

Study Start Date2023-01-01
Study Completion Date2027-06-30

Terms related to this study

Keywords Provided by Researchers

  • schizophrenia
  • bipolar disorder
  • schizoaffective disorder
  • schizophreniform
  • major depression
  • psychosis
  • delusional disorder
  • Biotypes
  • Biomarkers
  • coordinated specialty care

Additional Relevant MeSH Terms

  • Schizophrenia Spectrum and Other Psychotic Disorders
  • Schizophrenia
  • Delusional Disorder
  • Bipolar 1 Disorder
  • Schizoaffective Disorder
  • Psychosis Not Otherwise Specified
  • Early Psychosis