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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Cognitive Function [Срок оценки: Baseline, week8]
• Plasma Exosome Concentration [Срок оценки: Baseline]
• The MicroRNA Expression Profile [Срок оценки: Baseline]
• Plasma Exosome Size Distribution [Срок оценки: Baseline]

Вторичные конечные точки (6)

• Psychiatric Symptoms [Срок оценки: Baseline, week4, week8, week12]
• Depressive Symptoms [Срок оценки: Baseline, week4, week8, week12]
• Anxiety Symptoms [Срок оценки: baseline, week 4, week 8 and week 12]
• Sleep Quality [Срок оценки: baseline, week 4, week 8 and week 12]
• Aggressive behaviors [Срок оценки: Baseline]
• Brain Magnetic Resonance Imaging (MRI) [Срок оценки: Baseline]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Tianjin Anding Hospital — Тяньцзинь

Идентификаторы

NCT: NCT07139171 · FESW-TJAH

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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