MicroRNAs for Schizophrenia
(MIRFEST Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study investigates whether tiny molecules called microRNAs (miRNAs), found in special brain-derived "packages" (neural-derived extracellular vesicles, or NDEs) that travel from the brain into the blood, can serve as helpful indicators (biomarkers) for schizophrenia. Currently, doctors diagnose schizophrenia and monitor treatment primarily through clinical interviews, which can be slow and imprecise. This study will work with 80 individuals recently diagnosed with first-episode schizophrenia who are beginning treatment with either aripiprazole or risperidone, along with 80 healthy volunteers. Blood samples will be collected from all participants. For individuals with schizophrenia, blood will be drawn at the beginning of treatment and again after 12 weeks. By comparing patterns of brain-derived miRNAs in the blood of patients versus healthy volunteers, and by observing changes in these miRNAs during treatment, the researchers hope to discover whether these molecules can help diagnose schizophrenia more quickly and predict how well a treatment will work. If successful, this study will provide initial evidence that these miRNAs could become valuable new tools leading to earlier, more accurate diagnoses and more personalized treatment selection.
Who Is on the Research Team?
Juan Gallego, MD
Principal Investigator
Northwell Health
Are You a Good Fit for This Trial?
This trial is for people recently diagnosed with their first episode of schizophrenia or related psychotic disorders who are starting treatment with aripiprazole or risperidone, as well as healthy volunteers. Participants must be able to give blood samples and follow study procedures.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Trial Overview
Researchers are studying whether certain molecules (microRNAs) found in the blood can help diagnose schizophrenia and track how patients respond to treatment. Blood samples will be collected from both patients and healthy volunteers for analysis using advanced genetic tests.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
FES participants receiving naturalistic treatment with aripiprazole or risperidone as prescribed by their treating psychiatrist. Blood samples collected at baseline and week 12 for NDE miRNA analysis.
Healthy volunteers providing a single baseline blood sample for NDE miRNA analysis comparison.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northwell Health
Lead Sponsor
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