MicroRNAs as Biomarkers in First Episode Schizophrenia
This study is looking into whether tiny molecules called microRNAs (miRNAs) can help doctors diagnose schizophrenia and see how well treatments like aripiprazole or risperidone are working. These miRNAs are found in special brain-derived "packages" (neural-derived extracellular vesicles, or NDEs) that travel from the brain into your blood. Currently, diagnosing and monitoring schizophrenia relies mostly on talking with doctors, which can be less precise. This study aims to find more objective ways. You might be able to join if you are between 15 and 40 years old and have been recently diagnosed with a first episode of psychosis, including schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychosis Not Otherwise Specified (NOS). The study will measure the diagnostic performance of these miRNAs at the start of the study and their ability to predict how you respond to treatment after 12 weeks. The current recruitment status is unclear.
- Study design
- This is an interventional study with a planned enrollment of 160 participants. It involves collecting blood samples to analyze specific microRNAs and genetic information.
- What's involved
- You would provide blood samples at the beginning of the study and again after 12 weeks. One blood sample will also be used for whole genome sequencing.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess treatment response at Week 12, using baseline NDE miRNA levels.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
MicroRNAs as Biomarkers in First Episode Schizophrenia
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Juan Gallego, MD · PRINCIPAL_INVESTIGATOR · Northwell Health
Who to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- Diagnostic performance of plasma NDE miRNA panelBaseline (Week 0)
Sensitivity, specificity, and Area Under the Curve (AUC) of a panel of plasma NDE miRNAs in differentiating acutely psychotic First-Episode Schizophrenia (FES) participants from Healthy Volunteers (HV), assessed using Binary Elastic Net Regression and machine learning models.
- Predictive performance of baseline plasma NDE miRNA levels for treatment responseBaseline NDE miRNAs predicting response at Week 12
Predictive performance (AUC, accuracy, sensitivity, specificity) of baseline plasma NDE miRNA levels for clinical response to antipsychotic treatment (aripiprazole or risperidone). Treatment response defined as all 4 BPRS Thought Disturbance factor items below psychotic level (\<4) for 2 consecutive ratings with concomitant CGI ratings of much/very much improved.