MicroRNAs as Biomarkers in First Episode Schizophrenia

Part of paid clinical trials in Glen Oaks, New York.

Sponsor
Northwell Health
Study ID
NCT07703670
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
15 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Plasma NDE miRNA Sequencing — DIAGNOSTIC_TEST
    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.
  • Whole Genome Sequencing — GENETIC
    Single baseline blood sample collected for DNA extraction and whole genome sequencing to analyze genetic variation associated with psychosis and treatment response.

Study Details

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.

Key Dates

First listed
Jul 14, 2026
Start date
Jul 1, 2026
Status verified
Jul 2026
Primary completion
May 31, 2031
Completion
May 1, 2031

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: First-Episode Schizophrenia - Aripiprazole/Risperidone
    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.
  • Active Comparator: Healthy volunteers
    Healthy volunteers providing a single baseline blood sample for NDE miRNA analysis comparison.

Primary Outcome Measure

Diagnostic performance of plasma NDE miRNA panel [ Time Frame: Baseline (Week 0) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Zucker Hillside HospitalGlen OaksNew York11004
Nicole Montgomery
[email protected]
9494869390

Find similar trials in Glen Oaks, NY

By condition
Schizophrenia
By specialty
PsychiatryMental healthBehavioral health
By research site
Zucker Hillside Hospital· Glen Oaks, NY

Related Studies