Brain-derived miRNA biomarkers in first-episode psychosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates if microRNAs contained in neural-derived extracellular vesicles circulating in blood can serve as objective biomarkers for schizophrenia and treatment response. It enrolls 80 individuals with first-episode psychosis who begin aripiprazole or risperidone and 80 healthy controls, with blood samples collected at baseline and after 12 weeks for miRNA sequencing. The approach uses immunoprecipitation to isolate brain-derived vesicles and Illumina sequencing to profile miRNA cargo, alongside clinical and cognitive assessments. The goal is to determine whether these brain-specific miRNAs differ between patients and controls and whether they change with treatment. The trial design incorporates mechanistic analyses to explore diagnostic and pharmacodynamic potential of NDE miRNAs.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Acute first episode of psychosis with DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychosis Not Otherwise Specified (NOS)
2. Current positive symptoms rated ≥4 (moderate) on one or more of these BPRS items: hallucinatory behavior, unusual thought content, grandiosity, conceptual disorganization
3. Early phase of illness as defined by having taken antipsychotic drugs for a cumulative lifetime period ≤2 weeks
4. Age 15 to 40
5. Receiving or about to start naturalistic treatment with either aripiprazole or risperidone
6. Full capacity to consent

Exclusion Criteria:

* Participant voluntarily withdraws consent at any given time during the study
* Loss of capacity to consent during the study
* Treating psychiatrist determines that the participant requires an antipsychotic medication other than aripiprazole or risperidone due to adverse effects, poor tolerability, poor response, or any other reason
* The investigator, sponsor, independent safety monitor, or DSMB determines discontinuation is necessary to protect the participant
* Pregnancy is discovered during the study

Where it's running

• Zucker Hillside Hospital
  Glen Oaks, New York, United States Recruiting

Study contacts

• Principal investigator: Juan Gallego, MD — Northwell Health
• Study coordinator: Nicole Montgomery, MD
• Email: nmontgomery@northwell.edu
• Phone: 949-486-9390

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.