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

NCT ID: NCT07139171

Last Updated: 2025-09-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-11
• Study Completion Date: 2025-12-31

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.

Detailed Description

This single-center, prospective cohort study will enroll 200 drug-naive schizophrenia patients and 100 demographically matched healthy volunteers to identify biological signatures of cognitive impairment and to develop predictive models for subsequent change. At baseline we will administer the MATRICS Consensus Cognitive Battery (MCCB), clinical rating scales, multimodal magnetic resonance imaging (MRI), and collect fasting blood and first-morning urine for multi-omics assays. Participants are re-evaluated at 4, 8 and 12 weeks during naturalistic antipsychotic treatment, repeating cognitive testing, clinical scales, and blood/urine sampling. Primary analyses will link baseline omics to the MCCB overall composite score; secondary analyses will model the longitudinal trajectories of both cognition and biomarkers to derive parsimonious predictors of cognitive gain versus persistent impairment. The resulting biomarker panels are expected to inform future stratified clinical trials and mechanism-based cognitive remediation strategies.

Conditions

Schizophrenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tianjin Anding Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Tianjin Anding Hospital

Tianjin, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Jie Li, Doctor

Role: CONTACT

jieli@tjmhc.com

+86-022-88188006

Facility Contacts

Jie Li, Doctor

Role: primary

jieli@tjmhc.com

+86-022-88188006

Other Identifiers

FESW-TJAH

Identifier Type: -

Identifier Source: org_study_id