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MicroRNAs as Biomarkers in First Episode Schizophrenia

MicroRNAs in Neural-Derived Extracellular Vesicles as Biomarkers in First Episode Schizophrenia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
15 Years to 40 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Interviews, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Currently, doctors diagnose schizophrenia and monitor treatment primarily through clinical interviews, which can be slow and imprecise."
  • "Blood samples will be collected from all participants."
  • "Diagnosis and treatment assessment remain heavily reliant on clinical interviews, which are subjective and lack objective biological indicators."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether tiny molecules called microRNAs in blood can help find schizophrenia and predict how well treatment will work. It includes people with a first episode of schizophrenia or a related condition who are starting aripiprazole or risperidone, plus healthy volunteers. Everyone gives blood samples; people with schizophrenia give samples at the start and after 12 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 15 to 40 years old.
  • Have a first episode of psychosis, which can make it hard to tell what is real, with a diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychosis not otherwise specified.
  • Have at least one symptom rated moderate or worse: sensing things that are not there, unusual beliefs, beliefs about having special power or importance, or confused thinking.
  • Have taken medicines for psychosis for no more than 2 weeks total in your life.
  • Be taking or about to start aripiprazole or risperidone.
  • Be fully able to understand the study and agree to take part.

Who can't join

  • Choose to stop taking part at any time.
  • Lose the ability to understand the study and agree to take part.
  • Your psychiatrist decides you need a medicine other than aripiprazole or risperidone because of side effects, poor results, or another reason.
  • The study team, sponsor, or safety reviewers decide you must stop to protect your safety.
  • Pregnancy is found during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NY