Understanding early psychosis and its biological markers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The BICEPS study aims to explore the early stages of psychotic disorders such as Schizophrenia and Bipolar I Disorder by collecting mental health data, brain scans, eye movement patterns, and EEG data from participants. Over the course of a year, individuals will attend four visits where they will undergo various assessments, including clinical interviews and neuropsychological tests. The study seeks to identify clinical and biological predictors of outcomes in early psychosis, which could enhance treatment planning and intervention strategies. This multi-site study will involve approximately 320 participants across several institutions, coordinated by Boston's Beth Israel Deaconess Medical Center.

Why it matters

Who can join: the full rules

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

Where it's running

• Hartford Hospital
  Hartford, Connecticut, United States Recruiting
• University of Georgia
  Athens, Georgia, United States Recruiting
• University of Chicago Medical Center
  Chicago, Illinois, United States Recruiting
• McLean Hospital
  Belmont, Massachusetts, United States Recruiting
• Beth Israel Deaconess Medical Center
  Boston, Massachusetts, United States Recruiting
• University of Texas Southwestern Medical Center
  Dallas, Texas, United States Recruiting

Study contacts

• Principal investigator: Matcheri S. Keshavan, MD — Beth Israel Deaconess Medical Center
• Study coordinator: Matcheri S. Keshavan, MD
• Email: mkeshava@bidmc.harvard.edu
• Phone: 617-754-1256

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations

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• Trying the Kiso Mind smartphone app for people with schizophrenia spectrum disorders

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.