Plasma exosome microRNAs linked to cognitive problems in first-episode schizophrenia
Study on the Role and Mechanism of Plasma Exosome microRNAs in Cognitive Impairment in First-episode Schizophrenia
We will test whether patterns of plasma exosome microRNAs can explain or predict cognitive problems in people with first-episode, drug-naive schizophrenia.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Tianjin Anding Hospital Academic / other |
| Locations | 1 site (Tianjin) |
| Trial ID | NCT07139171 on ClinicalTrials.gov |
What this trial studies
This single-center prospective cohort will enroll 200 drug-naive, first-episode schizophrenia patients and 100 demographically matched healthy volunteers at Tianjin Anding Hospital. At baseline participants complete the MATRICS Consensus Cognitive Battery (MCCB), clinical rating scales, multimodal MRI, and provide fasting blood and first-morning urine for multi-omics assays focusing on plasma exosome microRNAs. Patients then receive naturalistic antipsychotic treatment and are re-evaluated at 4, 8, and 12 weeks with repeated cognitive testing and biosampling to capture longitudinal change. Analyses will link baseline omics signatures to MCCB composite scores and build predictive biomarker panels for cognitive improvement versus persistent impairment.
Who should consider this trial
Good fit: Ideal participants are Han Chinese adults with first-episode, drug-naive schizophrenia (and matched healthy volunteers) who can attend baseline and 4-, 8-, and 12-week in-person visits.
Not a fit: People with chronic or previously treated schizophrenia, major uncontrolled medical illnesses, substance-induced psychoses, or those who are pregnant or breastfeeding are unlikely to be eligible or to benefit from this protocol.
Why it matters
Potential benefit: If successful, the study could produce blood-based biomarkers that help predict who will recover cognitive function and guide targeted interventions or drug development.
How similar studies have performed: Small emerging studies have associated exosome microRNAs with psychiatric and cognitive changes, but using multi-omics and longitudinal prediction in first-episode, drug-naive schizophrenia is largely novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy volunteers matched to the patient group on sex, age, and education level; * No family history of psychiatric disorders among first- or second-degree relatives (two generations); * Ethnic Han Chinese; * Able and willing to provide written informed consent. Exclusion Criteria: * Any serious physical illness, including but not limited to uncontrolled hypertension, severe cardiovascular, cerebrovascular, pulmonary, thyroid, or metabolic disease, diabetes, epilepsy, or metabolic syndrome; * Current or past diagnosis of substance-induced psychotic disorder, delusional disorder, brief psychotic disorder, or mood disorder with psychotic features; * Pregnancy or breastfeeding; * Any condition that would interfere with the ability to give informed consent or complete study procedures.
Where this trial is running
Tianjin
- Tianjin Anding Hospital — Tianjin, China (Recruiting)
Study contacts
- Study coordinator: Jie Li, Doctor
- Email: jieli@tjmhc.com
- Phone: +86-022-88188006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.