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RECRUITING
NCT07703670
NA

MicroRNAs as Biomarkers in First Episode Schizophrenia

Sponsor: Northwell Health

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

15 Years - 40 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-07-01

Completion Date

2031-05-01

Last Updated

2026-07-14

Healthy Volunteers

Yes

Interventions

DIAGNOSTIC_TEST

Plasma 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.

GENETIC

Whole 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