SchizophreniaNCT07139171
Study on the Role and Mechanism of Plasma Exosome microRNAs in Cognitive Impairment in First-episode Schizophrenia
An observational study of Schizophrenia, run by Tianjin Anding Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 11 Nov 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Anding Hospital
Tianjin
Jie Li, Doctor, +86-022-88188006, jieli@tjmhc.com
About this study
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.
Read the 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
- Keywords
- schizophrenia, cognitive funciton, exosome, microRNA
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Baseline
Secondary outcomes (6)
Psychiatric Symptoms
The psychiatric symptoms of schizophrenia were assessed in all enrolled patients using the Positive and Negative Syndrome Scale (PANSS). The PANSS is a 30-item clinician-rated scale yielding a total score ranging from 30 (least symptomatic) to 210 (symptomatic), where higher scores indicate more severe psychopathology.
Measured: Baseline, week4, week8, week12
Depressive Symptoms
The Hamilton Depression Scale-24 (HAMD-24) was used to assess the severity of depressive symptoms. Each item was scored on a scale of 0 (none) to 4 (severe); the total score ranged from 0 to 76, with higher scores indicating more severe depressive symptoms.
Measured: Baseline, week4, week8, week12
Anxiety Symptoms
The Hamilton Anxiety Scale (HAMA) is used to assess the severity of anxiety symptoms. Each item is scored on a scale of 0 (none) to 4 (very severe), with a total score range of 0-56. Higher scores indicate more severe anxiety symptoms.
Measured: baseline, week 4, week 8 and week 12
Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) is used to assess sleep quality and sleep disorders over the past month. The questionnaire includes seven subscale scores (subjective sleep quality, sleep onset latency, sleep duration, habitual sleep efficiency, sleep disturbances, sleep medication use, and daytime functioning), with each subscale scored on a scale of 0 to 3. The sum of the seven subscale scores constitutes the PSQI total score, ranging from 0 to 21, with higher scores indicating poorer sleep quality.
Measured: baseline, week 4, week 8 and week 12
Aggressive behaviors
The Modified Open Aggression Scale (MOAS) is a four-component scale administered by clinicians or observers that quantifies verbal aggression, aggression toward objects, self-aggression, and physical aggression toward others. Each component consists of five items, with scores ranging from 0 (none) to 4 (extreme). The scores from each component are added together to produce a total weighted score ranging from 0 to 40, with higher scores indicating more severe overall aggressive behaviour.
Measured: Baseline
Brain Magnetic Resonance Imaging (MRI)
Multimodal 3 T MRI acquired at baseline, including T1-weighted anatomical imaging, diffusion tensor imaging (DTI) and resting-state functional MRI. Extracted metrics-cortical thickness, regional gray-matter volume, fractional anisotropy, mean diffusivity, and amplitude of low-frequency fluctuation-will be used to quantify structural and functional alterations associated with cognitive impairment.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start11 Nov 2022
- Primary completion1 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Anding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139171
- Sponsor's protocol ID
- FESW-TJAH
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2025
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Role and Mechanism of Plasma Exosome microRNAs in Cognitive Impairment in First-episode Schizophrenia
- ClinicalTrials.gov ID
- NCT07139171
- Acronym / sponsor ID
- FESW-TJAH
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, cognitive funciton, exosome, microRNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tianjin Anding HospitalUniversity, hospital or other
- Study start
- 11 Nov 2022 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cognitive Function
Time frame: Baseline, week8
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.
Plasma Exosome Concentration
Time frame: Baseline
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
The MicroRNA Expression Profile
Time frame: Baseline
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.
Plasma Exosome Size Distribution
Time frame: Baseline
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
6 secondary outcomes
Psychiatric Symptoms
Time frame: Baseline, week4, week8, week12
Depressive Symptoms
Time frame: Baseline, week4, week8, week12
Anxiety Symptoms
Time frame: baseline, week 4, week 8 and week 12
Sleep Quality
Time frame: baseline, week 4, week 8 and week 12
Aggressive behaviors
Time frame: Baseline
Brain Magnetic Resonance Imaging (MRI)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Tianjin Anding Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jie Li, Doctor (+86-022-88188006, jieli@tjmhc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognitive Function (time frame: Baseline, week8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.