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Understanding Early Psychosis and Specialty Services (BICEPS) Study

The BICEPS study is looking to better understand the early stages of psychotic disorders like Schizophrenia, Schizoaffective Disorder, and Bipolar I Disorder. This observational study will gather information about your mental health, take brain scans (MRI), measure eye movement patterns (Eye-Tracking), and record brain electrical waves (EEG). You may be eligible if you are between 18 and 40 years old and have been diagnosed with a psychotic disorder. The study aims to see how well treatments work (Treatment Response), if symptoms go away (Symptomatic Remission), and if you can return to daily activities (Functional Remission) over one year. The study is currently unclear on its recruitment status, but plans to enroll 320 participants.

Study design
This is an observational study, meaning no specific intervention is being tested. It plans to enroll 320 participants across multiple sites.
What's involved
You would be involved for about a year, with four visits during that time. Screening procedures, lasting about 3 hours, include tests for drug use, a pregnancy test (if applicable), clinical interviews, and a medical history review.
Compensation
Not stated in the trial record.
Follow-up
You will be followed from enrollment at baseline to the end of the study at 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06740383

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

Recruiting
Not specifiedAges 18–40Observational
Beth Israel Deaconess Medical Center
~320 participants
Updated 2026-03-10 on ClinicalTrials.gov

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Treatment Response
Measured over From enrollment at baseline to end of study at 1 year
+3 more outcomes measured

Conditions

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

Explore related trials

Bipolar I disorderDelusional DisorderPsychosis Not Otherwise SpecifiedSchizoaffective DisorderSchizophreniaSchizophreniform DisorderUnipolar Depression

Where it's being run

6 sites across 5 states
Massachusetts2
Connecticut1
Georgia1
Illinois1
Texas1

Study leadership

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

Who to contact

Matcheri S. Keshavan, MD
[email protected]
617-754-1256
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Treatment ResponseFrom enrollment at baseline to end of study at 1 year

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

  • Symptomatic RemissionFrom enrollment at baseline to end of study at 1 year

    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

  • Functional RemissionFrom enrollment at baseline to end of study at 1 year

    Score ≥ 7 on Global Functioning Role and Social Scales

  • RelapseFrom enrollment at baseline to end of study at 1 year

    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.