RightFit
RecruitingPhase not listed

Biomarkers/Biotypes, Course of Early Psychosis and Specialty Services

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 40 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Visits mentioned: 4 visits
  • Procedures mentioned: MRI scans, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at whether brain tests and other body signs can help predict how people with early psychosis respond to specialty care. Psychosis can make it hard to tell what is real. It is for adults ages 18–40 whose psychosis started within the past 4 years, and involves four visits over about a year.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Adults ages 18–40 of any sex, race, or ethnic background.
  • Have a diagnosed psychotic disorder, such as schizophrenia, schizoaffective disorder, bipolar I disorder, depression with psychosis, or a disorder involving false beliefs.
  • Psychosis started no more than 4 years ago.
  • Can read, speak, and understand English.
  • Can and will give written consent and follow the study plan.
  • At the first visit, receive both mental health medicine and talk therapy.

Who can't join

  • A word-reading test gives a score below 70 when used to estimate learning ability before the illness.
  • Have a health condition that may affect the brain, such as seizures, stroke, AIDS, or a head injury that caused loss of consciousness for at least 30 minutes.
  • Have an alcohol or drug use disorder that may explain the psychosis. A cannabis use disorder is allowed if it is not linked to when psychosis began.
  • For MRI scans only: pregnant.
  • For MRI scans only: have metal objects in the body that are attracted to magnets.
  • For MRI scans only: weigh more than 300 pounds or have a body size beyond the scanner's limits.
  • For MRI scans only: have claustrophobia, a fear of tight or closed spaces.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (6)

CT

GA

IL

MA

TX