Biomarkers for Early Psychosis
(BICEPS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to better understand the early stages of psychotic disorders, such as schizophrenia and bipolar disorder, by examining brain function, genetics, and cognitive abilities. Researchers will collect data from brain scans, eye movements, and brain waves to determine how these factors relate to symptoms and treatment responses. The goal is to predict which treatments work best for different individuals with early psychosis. This trial is ideal for those diagnosed with a psychotic disorder within the past three years and willing to participate in several assessments over a year. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future treatment strategies for early psychosis.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What prior data suggests that these research procedures are safe?
Research has shown that special early intervention teams and Coordinated Specialty Care (CSC) programs are safe for individuals experiencing early signs of psychosis. These programs aim to treat individuals early in their illness to improve recovery chances. Studies have found that CSC programs reduce symptoms and enhance the quality of life for those with schizophrenia and other psychotic disorders. No major safety concerns have been reported, and participants generally tolerate the programs well. Structured support helps individuals manage their condition effectively.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to uncover important biomarkers and biotypes associated with early psychosis. Unlike typical treatments that focus solely on managing symptoms, this trial seeks to understand the underlying biological factors contributing to the condition. By identifying specific biomarkers, the goal is to develop more personalized and effective treatment strategies, potentially leading to better outcomes for patients. This approach could revolutionize how early psychosis is diagnosed and treated, moving towards customized care tailored to an individual's unique biological profile.
What evidence suggests that this trial's treatments could be effective for early psychosis?
Research has shown that special programs for early psychosis can improve patient outcomes. Studies indicate that participants in these programs often experience better mental health, enjoy a higher quality of life, and function better socially and in their roles. One study found that individuals receiving these services had fewer symptoms and felt better overall over time. Another analysis highlighted that starting these services early is cost-effective and can save money in the long run. Overall, evidence supports that these special programs greatly benefit people in the early stages of psychotic disorders.678910
Who Is on the Research Team?
Matcheri S. Keshavan, MD
Principal Investigator
Beth Israel Deaconess Medical Center
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Initial assessments including clinical interviews, psychiatric and family history, medical history review, and biomarker assessments (EEG, eye-tracking, MRI)
Treatment and Monitoring
Participants receive Coordinated Specialty Care (CSC) treatment and undergo repeated clinical and cognition assessments at 1, 6, and 12 months
Follow-up
Participants are monitored for changes in symptoms and cognitive function through modified clinical interviews and neuropsychological tests
What Are the Treatments Tested in This Trial?
Interventions
- Specialty Services
Find a Clinic Near You
Who Is Running the Clinical Trial?
Beth Israel Deaconess Medical Center
Lead Sponsor
University of Texas Southwestern Medical Center
Collaborator
Hartford Hospital
Collaborator
National Institute of Mental Health (NIMH)
Collaborator
University of Chicago
Collaborator
Yale University
Collaborator
University of Georgia
Collaborator
Mclean Hospital
Collaborator
Citations
Outcomes During and After Early Intervention Services for ...
Outcomes during and after early intervention services for first-episode psychosis: results over 5 years from the RAISE-ETP site-randomized trial.
Fidelity to Common Elements of Coordinated Specialty Care
Across programs, clients experienced improved symptoms, higher quality of life, and improved social and role functioning. Of note, participants ...
3.
nami.org
nami.org/wp-content/uploads/2024/11/Scaling-CSC-for-FEP-Insights-from-a-National-Impact-Model.pdfScaling Coordinated Specialty Care for First-Episode ...
Impact was assessed across five categories (health care, employment, housing, criminal justice, and caregiving) based on available data in ...
Comparing interventions for early psychosis: a systematic ...
Primary outcomes were negative and positive psychotic symptoms at 3-month and 1-year follow-up and treatment dropouts. Secondary outcomes were ...
Coordinated Specialty Care for First Episode Psychosis
Analyses suggest that early psychosis intervention is cost-effective and results in cost savings. Tarride et al.33. 2022 Canada. Predictive.
Specialised early intervention teams for recent‐onset psychosis
The purpose of SEI teams is to intensively treat people with psychosis early in the course of the illness with the goal of increasing the likelihood of recovery ...
7.
psychiatrictimes.com
psychiatrictimes.com/view/coordinated-specialty-care-paving-the-way-for-psychosis-recoveryCoordinated Specialty Care: Paving the Way for Psychosis ...
Early intervention in schizophrenia enhances recovery, reduces symptoms, and improves quality of life through coordinated specialty care programs across the US.
Special Report: What Is 'Coordinated Specialty Care,' and ...
Early intervention programs for people with psychosis or at high risk of psychosis have expanded rapidly. Coordinated Specialty Care is one ...
Coverage of Coordinated Specialty Care (CSC) for Early or ...
Symptoms of psychosis can also include speech that does not make sense, difficulty thinking clearly, lack of self-care, withdrawal and odd or inappropriate ...
10.
library.samhsa.gov
library.samhsa.gov/product/coordinated-specialty-care-first-episode-psychosis-costs-and-financing-strategies/pep23-01-00-003Coordinated Specialty Care for First Episode Psychosis
This report will include data on the cost of CSC programs; how it is financed; case studies of cost reimbursement methodologies; funding options.
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