MicroRNAs as Biomarkers in First Episode Schizophrenia
Recruiting · NCT07703670 · Interventional (participants receive a specific treatment) · Lead sponsor: Northwell Health
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 can take part
Inclusion criteria
- 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
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
Where it is running
1 location listed across 1 US state.
- Zucker Hillside Hospital - Glen Oaks, New York, United States