Recruiting

Observational Study

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT06740383

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Schizophrenia

Delusional Disorder

Bipolar 1 Disorder

Schizoaffective Disorder

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06740383

Start date

Jan 1, 2023

Status verified date

Mar, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 40

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

320 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Treatment Response [ Time Frame: From enrollment at baseline to end of study at 1 year ]
  • Symptomatic Remission [ Time Frame: From enrollment at baseline to end of study at 1 year ]
  • Functional Remission [ Time Frame: From enrollment at baseline to end of study at 1 year ]
  • Relapse [ Time Frame: From enrollment at baseline to end of study at 1 year ]

Central Contacts and Locations

Central contacts

Matcheri S. Keshavan, MD

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

Brendan Stiltner, BA

bstiltne@bidmc.harvard.edu

Locations

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Godfrey Pearlson, MA, MBBS

860.545.7757Godfrey.Pearlson@HHChealth.org

Principal Investigator:

Godfrey Pearlson, MA, MBBS

University of Georgia

Recruiting

Athens, Georgia, United States, 30602

Contacts

Brett Clementz, PhD

706-542-2174clementz@uga.edu

Principal Investigator:

Brett Clementz, PhD

University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Sarah K. Keedy, PhD

773-834-7178skeedy@bsd.uchicago.edu

Elliot S. Gershon, MD

egershon@bsd.uchicago.edu

Principal Investigator:

Sarah S. Keedy, PhD

McLean Hospital

Recruiting

Belmont, Massachusetts, United States, 02478

Contacts

Kathryn E. Lewandowski, PhD

617-855-2886klewanowski@mclean.harvard.edu

Principal Investigator:

Kathryn E Lewandowski, PhD

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215-5400

Contacts

Matcheri S. Keshavan, MD

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

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Carol Tamminga, MD

214-404-2284carol.tamminga@UTSouthwestern.edu

Principal Investigator:

Carol Tamminga, MD

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Mar 10, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-03-10.