Plasma exosome microRNAs linked to cognitive problems in first-episode schizophrenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Tianjin Anding Hospital
  Tianjin, China Recruiting

Study contacts

• Study coordinator: Jie Li, Doctor
• Email: jieli@tjmhc.com
• Phone: +86-022-88188006

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.