NCT07703670Recruiting
MicroRNAs as Biomarkers in First Episode Schizophrenia
MicroRNAs in Neural-Derived Extracellular Vesicles as Biomarkers in First Episode Schizophrenia
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 160 (estimated)
- First submitted
- 4 Jun 2026
- Start date
- 1 Jul 2026
- Primary completion date
- May 2031
- Lead sponsor
- Northwell Health
- Diseases
- Schizophrenia
- NCT number
- NCT07703670
What you commit to
- Study type: Interventional
- Planned participants: 160
- From 1 Jul 2026 to the primary completion date, May 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other
- Participant voluntarily withdraws consent at any given time during the study
- Loss of capacity to consent during the study
- The investigator, sponsor, independent safety monitor, or DSMB determines discontinuation is necessary to protect the participant
- Pregnancy is discovered during the study
Who the study is looking for
- 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
Age in the registry: 15 years to 40 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Zucker Hillside Hospital Coordinator of this site? Confirm its status | Glen Oaks | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.