RecruitingNot ApplicableNCT07703670

MicroRNAs as Biomarkers in First Episode Schizophrenia

MicroRNAs in Neural-Derived Extracellular Vesicles as Biomarkers in First Episode Schizophrenia


Sponsor

Northwell Health

Enrollment

160 participants

Start Date

Jul 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 15 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Plasma NDE miRNA Sequencing and Whole Genome Sequencing for people with psychosis not otherwise specified (nos), schizoaffective disorder, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 15 Years to 40 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPlasma NDE miRNA Sequencing

Blood samples collected at baseline and week 12 for isolation of neural-derived extracellular vesicles (NDEs) from plasma using L1/NCAM antibody immunoprecipitation, followed by small RNA sequencing on Illumina NovaSeq6000 to identify differentially expressed miRNAs.

GENETICWhole Genome Sequencing

Single baseline blood sample collected for DNA extraction and whole genome sequencing to analyze genetic variation associated with psychosis and treatment response.


Locations(1)

Zucker Hillside Hospital

Glen Oaks, New York, United States

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NCT07703670


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