Schizophrenia Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Genetic, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 40
Healthy Volunteers: t
View:

• Acute first episode of psychosis with DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychosis Not Otherwise Specified (NOS)

• Current positive symptoms rated ≥4 (moderate) on one or more of these BPRS items: hallucinatory behavior, unusual thought content, grandiosity, conceptual disorganization

• Early phase of illness as defined by having taken antipsychotic drugs for a cumulative lifetime period ≤2 weeks

• Age 15 to 40

• Receiving or about to start naturalistic treatment with either aripiprazole or risperidone

• Full capacity to consent

Locations
United States
New York
Zucker Hillside Hospital
RECRUITING
Glen Oaks
Contact Information
Primary
Nicole Montgomery, MD
nmontgomery@northwell.edu
949-486-9390
Backup
Juan Gallego, MD, MS
NMontgomery@northwell.edu
718-470-4588
Time Frame
Start Date: 2026-07-01
Estimated Completion Date: 2031-05-01
Participants
Target number of participants: 160
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Northwell Health

This content was sourced from clinicaltrials.gov