Recruiting

miRNAs with Aripiprazole & Risperidone

Sponsor:

Northwell Health

Code:

NCT07703670

Conditions

Schizophrenia Disorder

Schizophreniform Disorder

Schizoaffective Disorder

Psychosis Not Otherwise Specified (NOS)

Eligibility Criteria

Sex: All

Age: 15 - 40

Healthy Volunteers: Accepted

Interventions

Plasma NDE miRNA Sequencing

Whole Genome Sequencing

Study Details

Brief 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.

Conditions

Schizophrenia Disorder

Schizophreniform Disorder

Schizoaffective Disorder

Psychosis Not Otherwise Specified (NOS)

Study ID

NCT07703670

Start date

Jul 1, 2026

Status verified date

Jul, 2026

Completion date

May 1, 2031

Anticipated

Primary completion date

May, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15 - 40

Healthy Volunteers: Accepted

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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

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.

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.

Primary outcome measure

  • Diagnostic performance of plasma NDE miRNA panel [ Time Frame: Baseline (Week 0) ]
  • Predictive performance of baseline plasma NDE miRNA levels for treatment response [ Time Frame: Baseline NDE miRNAs predicting response at Week 12 ]

Central Contacts and Locations

Central contacts

Nicole Montgomery, MD

949-486-9390nmontgomery@northwell.edu

Juan Gallego, MD, MS

718-470-4588NMontgomery@northwell.edu

Locations

Zucker Hillside Hospital

Recruiting

Glen Oaks, New York, United States, 11004

Contacts

Nicole Montgomery

9494869390NMontgomery@northwell.edu

More Information

Sponsor

Northwell Health

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Keywords

  • miRNA
  • biomarkers
  • first episode
  • neural derived extracellular vesicles
  • exosomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2026-07-14.