Skip to content

Metabolomics-based approach for identifying early cognitive impairment biomarkers in schizophrenia

Metabolomics-based approach for identifying early cognitive impairment biomarkers in schizophrenia

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400085909
Enrollment
Unknown
Registered
2024-06-20
Start date
2024-07-01
Completion date
Unknown
Last updated
2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Interventions

Patient group:None
Healthy control:None

Sponsors

Tianjin Anding Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: Patient group: (1) Patients who meet the diagnostic criteria for "schizophrenia" or "schizophrenia-like disorders" as outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), and whose diagnosis is independently confirmed by at least two attending psychiatrists or psychiatrists of higher rank; (2) Aged 18-50 years old; (3) Either gender; (4) Han ethnicity; (5) Education level of primary school or above; (6) No prior systematic treatment with antipsychotic medications (defined as continuous use of antipsychotic medications for more than 2 weeks or cumulative use exceeding 4 weeks), and no use of antipsychotic medications for at least 2 weeks prior to enrollment in the study; (7) Total score on the Positive and Negative Syndrome Scale (PANSS) = 60 points; (8) Able to complete cognitive function tests using the MATRICS Consensus Cognitive Battery (MCCB); (9) Patient or family member agrees to participate in the study and signs an informed consent form. Healthy control group: (1) Healthy individuals matched with the patient group in terms of gender, age, and education level; (2) Han ethnicity; (3) No history of antipsychotic medication use; (4) Able to complete cognitive assessment using the MCCB, with cognitive deficit score less than 3 points; (5) Agree to participate in the study and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Patient group: (1) Individuals diagnosed with any psychiatric disorder other than "schizophrenia" or "schizophrenia-like disorders" according to DSM-5 criteria; (2) Currently suffering from severe neurological diseases (such as dementia), metabolic disorders, severe diseases of the liver, kidney, cardiovascular system, lung, blood, urinary system, gastrointestinal diseases, infections, autoimmune diseases, malignant tumors, etc.; (3) History of gastric or intestinal surgery; (4) Use of antibiotics or other immunosuppressants, hormones, probiotics, and prebiotics within the past month; (5) History of significant suicidal or aggressive behavior; (6) Underwent physical treatments such as electroconvulsive therapy or transcranial magnetic stimulation within the past month; (7) Alcohol abuse or history of use of other psychoactive substances; (8) Pregnant or lactating women; (9) Any factors that hinder the provision of informed consent or participation in the study. Healthy control group: (1) Individuals diagnosed with any psychiatric disorder according to DSM-5 criteria; (2) Currently suffering from severe neurological diseases (such as dementia), metabolic disorders, severe diseases of the liver, kidney, cardiovascular system, lung, blood, urinary system, gastrointestinal diseases, infections, autoimmune diseases, malignant tumors, etc.; (3) History of gastric or intestinal surgery; (4) Use of antibiotics or other immunosuppressants, hormones, probiotics, and prebiotics within the past month; (5) Alcohol abuse or history of use of other psychoactive substances; (6) Positive family history of psychiatric disorders in two or three generations; (7) Pregnant or lactating women; (8) Any factors that hinder the provision of informed consent or participation in the study. Healthy subjects in this study will be recruited from the community.

Design outcomes

Primary

MeasureTime frame
Cognitive function assessment;metabolites level;

Secondary

MeasureTime frame
Reduction rate of positive and negative symptom scales;

Countries

China

Contacts

Public ContactYeqing Dong

Tianjin Anding Hospital

dongyeqing@tmu.edu.cn+86 22 8818 8875

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026