Study on the Role and Mechanism of Plasma Exosome microRNAs in Cognitive Impairment in First-episode Schizophrenia

NCT07139171 | Recruiting DMC

• 1 other identifier: FESW-TJAH
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Schizophrenia is a severe mental illness characterised by positive symptoms, negative symptoms, and cognitive symptoms. In recent years, an increasing number of doctors and scholars have focused on cognitive symptoms; however, the mechanisms underlying cognitive impairment remain unclear. Recently, exosome research methods have provided new avenues for investigation. This study applies exosome research methods to first-episode, drug-naive schizophrenia patients to explore gene expression changes associated with cognitive impairment and gain a deeper understanding of the mechanisms underlying cognitive impairment. By integrating basic research with clinical findings, we aim to further investigate the molecular mechanisms underlying cognitive impairment in schizophrenia patients, identify potential intervention targets, and provide insights for future drug development.

Conditions

Schizophrenia

Keywords

schizophrenia; cognitive funciton; exosome; microRNA

Outcome Measures

Primary Outcomes (4)

• Cognitive Function

  All participants underwent cognitive function assessment based on the MATRICS Consensus Cognitive Battery (MCCB). The battery covers seven cognitive domains and two composite scores. The MCCB scoring procedure generates standardised T-scores that are corrected for age, gender, and educational level. Higher T-scores indicate better cognitive function.

  Baseline, week8

• Plasma Exosome Concentration

  Fasting plasma samples collected at baseline will be processed by standard ultracentrifugation and nanoparticle tracking analysis (NTA) to quantify total exosome concentration, expressed as particles/mL. This single parameter will serve as the primary biomarker to evaluate its association with cognitive impairment in antipsychotic-naïve schizophrenia patients

  Baseline

• The MicroRNA Expression Profile

  Levels of microRNAs isolated from plasma-derived exosomes at baseline, quantified by Quantitative Reverse Transcription Polymerase Chain Reaction using a validated panel of schizophrenia- and cognition-related miRNAs, reported as fold-change relative to exogenous spike-in control.

  Baseline

• Plasma Exosome Size Distribution

  Fasting plasma samples collected at baseline will be processed by standard ultracentrifugation and nanoparticle tracking analysis (NTA) to quantify total exosome size distribution (mode, mean, and particle diameter range), expressed as particles/mL. This single parameter will serve as the primary biomarker to evaluate its association with cognitive impairment in antipsychotic-naïve schizophrenia patients

  Baseline

Secondary Outcomes (6)

• Psychiatric Symptoms

  Baseline, week4, week8, week12

• Depressive Symptoms

  Baseline, week4, week8, week12

• Anxiety Symptoms

  baseline, week 4, week 8 and week 12

• Sleep Quality

  baseline, week 4, week 8 and week 12

• Aggressive behaviors

  Baseline

Study Arms (2)

Schizophrenic Patients

200 individuals aged 18-65 years meeting DSM-5 criteria for schizophrenia or schizophreniform disorder. Participants must be in their first illness episode and either completely antipsychotic-naïve or have received antipsychotic medication for ≤ 4 weeks lifetime and ≤ 2 weeks immediately before enrollment. All provide written informed consent.

Healthy Control

100 Han Chinese volunteers aged 18-65 years who are group-matched to patients on sex, age, and education. All have no personal history of any psychiatric disorder, no family history of psychotic illness in first- or second-degree relatives and provide written informed consent.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will recruit two groups from the outpatient and inpatient services of Tianjin Anding Hospital and surrounding communities in Tianjin, China. The patient cohort will consist of 200 Han Chinese adults aged 18-65 years who are in their first episode of schizophrenia or schizophreniform disorder and have never received antipsychotics or received them for ≤4 weeks lifetime and ≤2 weeks immediately before enrollment. The healthy control cohort will include 100 Han Chinese adults matched to the patient group on sex, age, and education; they must have no personal or family history of major psychiatric disorders and show no cognitive impairment on formal testing.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Anding Hospital: lead

Study Sites (1)

Tianjin Anding Hospital

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Jie Li, Doctor

CONTACT

+86-022-88188006; jieli@tjmhc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 24, 2025
• Study Start: November 11, 2022
• Primary Completion: October 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 24, 2025

Record last verified: 2025-09

Locations

CN (1)