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New treatment option for Schizophrenia Disorder
Official title MicroRNAs as Biomarkers in First Episode Schizophrenia
ClinicalTrials.gov ID: NCT07703670
What this study is testing
What is Whole Genome Sequencing?
Whole Genome Sequencing is an investigational medicine, given as an once-daily, being studied as a potential treatment for schizophrenia disorder.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 to 40. Healthy volunteers may be eligible.
You may be able to join if
- Acute first episode of psychosis with DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychosis Not...
- Current positive symptoms rated ≥4 (moderate) on one or more of these BPRS items: hallucinatory behavior, unusual thought content, grandiosity...
- 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
You likely can't join if
- 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...
- The investigator, sponsor, independent safety monitor, or DSMB determines discontinuation is necessary to protect the participant
- Pregnancy is discovered during the study
See the full eligibility 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
- 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 side effects, 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
The study team makes the final eligibility decision.
Where it's taking place
- Glen Oaks, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Glen Oaks, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.