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Blood test may spot schizophrenia early and guide treatment

NCT ID NCT07703670

Knowledge-focused Sponsor: Northwell Health Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This study investigates whether microRNAs found in brain-derived particles in the blood can serve as biomarkers for schizophrenia. Researchers will compare blood samples from 80 people recently diagnosed with first-episode schizophrenia and 80 healthy volunteers, tracking changes over 12 weeks of treatment. The goal is to see if these molecules can help diagnose schizophrenia faster and predict which medication will work best for each person.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could lead to a simple blood test to diagnose schizophrenia earlier and help doctors choose the right medication faster.
What could go wrong
This is an early-stage observational study. The microRNA patterns may not prove reliable enough for clinical use, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 to 40 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

psychotic disorder Psychotic Disorders schizoaffective disorder schizophrenia schizophreniform disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Psychosis not otherwise specified (NOS) Schizoaffective disorder Schizophrenia disorder Schizophreniform disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Zucker Hillside Hospital

    RECRUITING

    Glen Oaks, New York, 11004, United States

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