Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

NCT06740383 | Recruiting

• 2 other identifiers: 2022P000622R01MH127174-03
• Study Type: observational
• Target: 320
• Locations: 1 country
• Sites: 6

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Treatment Response

  \>30% reduction in Positive and Negative Syndrome Scale (PANSS) score

  From enrollment at baseline to end of study at 1 year

• Symptomatic Remission

  Score of ≤ 3 on 8 core on the Positive and Negative Syndrome Scale (PANSS) items (P1, P2, P3, 1, N4, N6, N7, G5, and G9) for at least one month

  From enrollment at baseline to end of study at 1 year

• Functional Remission

  Score ≥ 7 on Global Functioning Role and Social Scales

  From enrollment at baseline to end of study at 1 year

• Relapse

  1\) Positive and Negative Syndrome Scale (PANSS) score of ≥ 4 for a psychosis item (P1, P2, P3, and P6) and ≥ 25% increase on the total PANSS score or ≥ 10 points and 2) an increased level of care, i.e. hospitalization, ER visits, etc.

  From enrollment at baseline to end of study at 1 year

Study Arms (1)

Individuals with Early Psychosis enrolled in Coordinated Specialty Care Clinics

In this naturalistic longitudinal study, we administer the B-SNIP biomarker batter to individuals with Early Psychosis (EP) in EP clinics with Coordinated Specialty Care treatment programs to characterize outcome trajectories and biotypes. EP individuals of both sexes, age 18-40 will be included after they meet study criteria and provide informed consent. Individuals with psychosis duration \< 4 years will be included. Individuals in this cohort of EP are diagnosed with Schizophrenia, Schizoaffective Disorder, Schizophreniform, Bipolar I Disorder with psychotic features, Delusional Disorder, Major Depressive Disorder with psychotic features, and Psychosis Not Otherwise Specified.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Participants are recruited from 5 different sites across the United States including Boston, Dallas, Hartford, Chicago, and Georgia. The target population for this study includes individuals who meet DSM-5 criteria for a psychotic disorder (i.e., schizophrenia, schizophreniform, schizoaffective disorder, bipolar I disorder or major depression with psychotic features, delusional disorder, or psychosis N.O.S.). Participants will be between 18 and 40 years of age, males and females, of all races and ethnicities who are experiencing early course psychosis.

You may qualify if:

• Males and females, all races and ethnicities
• 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

You may not qualify if:

• 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)
• Pregnant women
• Presence of ferromagnetic objects in body
• Weight or body size exceeding scanner capacity (\>300 lbs)
• Claustrophobia

Sponsors & Collaborators

• University of Chicago: collaborator
• University of Texas Southwestern Medical Center: collaborator
• Yale University: collaborator
• Hartford Hospital: collaborator
• University of Georgia: collaborator
• Mclean Hospital: collaborator
• National Institute of Mental Health (NIMH): collaborator
• Beth Israel Deaconess Medical Center: lead

Study Sites (6)

Hartford Hospital

Hartford, Connecticut, 06102, United States

RECRUITING

University of Georgia

Athens, Georgia, 30602, United States

RECRUITING

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

McLean Hospital

Belmont, Massachusetts, 02478, United States

RECRUITING

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215-5400, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

venous blood samples, buccal swab samples, and saliva samples

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Schizophrenia, Paranoid; Psychotic Disorders; Bipolar Disorder; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Mental Disorders; Bipolar and Related Disorders; Mood Disorders; Depressive Disorder

Study Officials

• Matcheri S. Keshavan, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Matcheri S. Keshavan, MD

CONTACT

617-754-1256; mkeshava@bidmc.harvard.edu

Brendan Stiltner, BA

CONTACT

bstiltne@bidmc.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Stanley Cobb Professor of Psychiatry

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: December 18, 2024
• Study Start: January 1, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: January 1st 2023 until June 30th 2028, one year after study completion
• Access Criteria: The study has been registered in NIH/NIMH Data Archive (NDA) (Study#: C4330). Data Submission Agreement is in place. The data will be uploaded to NDA during regular data sharing cycles.

Locations

US (6)