160 Participants NeededMy employer runs this trial

MicroRNAs for Schizophrenia

(MIRFEST Trial)

NM
JG
Overseen ByJuan Gallego, MD, MS
Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Northwell Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

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Juan Gallego, MD

Principal Investigator

Northwell Health

Are You a Good Fit for This Trial?

This trial is for people recently diagnosed with their first episode of schizophrenia or related psychotic disorders who are starting treatment with aripiprazole or risperidone, as well as healthy volunteers. Participants must be able to give blood samples and follow study procedures.

Inclusion Criteria

I am able to understand and agree to participate in this study.
I am experiencing my first episode of psychosis and have a related diagnosis.
I am taking or will soon start aripiprazole or risperidone.
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Exclusion Criteria

I am able to give consent and make decisions throughout the study.
My doctor says I need a different antipsychotic because aripiprazole or risperidone don't work for me.
Investigator, sponsor, independent safety monitor, or DSMB determines discontinuation is necessary to protect the participant
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What Are the Treatments Tested in This Trial?

Trial Overview

Researchers are studying whether certain molecules (microRNAs) found in the blood can help diagnose schizophrenia and track how patients respond to treatment. Blood samples will be collected from both patients and healthy volunteers for analysis using advanced genetic tests.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: First-Episode Schizophrenia - Aripiprazole/RisperidoneExperimental Treatment2 Interventions
Group II: Healthy volunteersActive Control2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials
481
Recruited
470,000+