NCT07703670 MicroRNAs as Biomarkers in First Episode Schizophrenia
| NCT ID | NCT07703670 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northwell Health |
| Condition | Schizophrenia Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2031-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2026-07-01 with a primary completion date of 2031-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Juan Gallego, MD
PRINCIPAL INVESTIGATOR
Northwell Health
Frequently Asked Questions
Who can join the NCT07703670 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, up to 40 Years, studying Schizophrenia Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07703670 currently recruiting?
Yes, NCT07703670 is actively recruiting participants. Contact the research team at nmontgomery@northwell.edu for enrollment information.
Where is the NCT07703670 trial being conducted?
This trial is being conducted at Glen Oaks, United States.
Who is sponsoring the NCT07703670 clinical trial?
NCT07703670 is sponsored by Northwell Health. The principal investigator is Juan Gallego, MD at Northwell Health. The trial plans to enroll 160 participants.
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