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The mechanisms and intervention strategies of the interaction between metabolism and immunity in the onset and development of schizophrenia

The mechanisms and intervention strategies of the interaction between metabolism and immunity in the onset and development of schizophrenia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400087353
Enrollment
Unknown
Registered
2024-07-25
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-29

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

Conditions

Schizophrenia

Interventions

Healthy control:Four hundred healthy controls received no intervention.
Schizophrenia patients (Four hundred schizophrenia patients were used to establish the model, and one hundred schizophrenia patients were used for independent validation. A single antipsychotic medica

Sponsors

Peking University Sixth Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: (1) Inclusion criteria for schizophrenia patients: Inclusion criteria include: (i) first-episode or relapsed schizophrenia that has not been systematically treated, meeting DSM-5 diagnostic criteria, with a Positive and Negative Syndrome Scale (PANSS) score of =60; (ii) aged 18-55 years, BMI not exceeding 24 kg/m2, and having at least one caregiver who will provide supervision over the next year; (iii) expected stability in residence and accessibility to transportation and medical care throughout the study; (iv) informed consent obtained from both the patient and the caregiver, with a signed consent form. These criteria were applied to both the 400 modeling samples and the 100 independent validation samples of schizophrenia. (2) Inclusion criteria for healthy controls: Inclusion criteria include: (i) physically healthy, with no psychiatric disorders meeting DSM-5 diagnostic criteria; (ii) no family history of psychiatric disorders; (iii) no current severe physical illnesses; (iv) aged 18-55 years; gender and educational level not statistically different from the patient group; (v) able to comply with the project's assessment requirements and has given informed consent. No contraindications for MRI scans. These criteria were applied to the 400 healthy controls.

Exclusion criteria

Exclusion criteria: (1) Exclusion criteria for schizophrenia patients: Exclusion criteria include: (i) comorbidity with metabolic immunological diseases and severe physical illnesses or substance abuse, including alcohol; (ii) severe physical disabilities that prevent completion of follow-ups; (iii) coexistence of other severe mental disorders, intellectual developmental delays, dementia, or severe cognitive impairments; (iv) patients currently participating in or preparing to participate in other clinical studies. These criteria were applied to both the 400-modeling samples and the 100 independent validation samples of schizophrenia. (2) Exclusion criteria for healthy controls: Exclusion criteria include: (i) presence of metabolic immune system diseases or history of substance dependence; (ii) presence of traumatic brain injury, epilepsy, or other cerebro-organic diseases; (iii) diagnosed with significant hypertension, diabetes, or other physical diseases; (iv) laboratory findings indicating liver or kidney function impairment or other severe physical diseases and metabolic disorders; (v) pregnant or lactating women. These criteria were applied to both the 400 healthy controls.

Design outcomes

Primary

MeasureTime frame
Positive and Negative Syndrome, PANSS;

Secondary

MeasureTime frame
MATRICS Consensus Cognitive Battery, MCCB;Abnormal Involuntary Movement Scale, AIMS;Clinical global impression scale, CGI;

Countries

China

Contacts

Public ContactWeihua Yue

Peking University Sixth Hospital

dryue@bjmu.edu.cn+86 188 1089 8027

Outcome results

None listed

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