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Establishing a Clinical Database and Biobank for Schizophrenia:A Cohort Study

Establishing a Clinical Database and Biobank for Schizophrenia:A Cohort Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112186
Enrollment
Unknown
Registered
2025-11-11
Start date
2024-01-02
Completion date
Unknown
Last updated
2025-11-17

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

Conditions

Cognitive Impairment in Schizophrenia Patients: A Review of Transcranial Magnetic Stimulation

Interventions

Schizophrenia group:none
Healthy control group:none
Transcranial Magnetic Stimulation (TMS) of the Supramarginal Gyrus for the Improvement of Negative Symptoms (Experimental Group):active stimulation
Transcranial Magnetic Stimulation (TMS) of the Supramarginal Gyrus for the Improvement of Negative Symptoms (Control Group):sham stimulation

Sponsors

Second Xiangya Hospital of CSU
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Schizophrenia Cohort Inclusion Criteria: 1. Clinical diagnosis of schizophrenia according to ICD-11; 2. Confirmation of schizophrenia diagnosis via SCID-5-CV (Clinical Version of the Structured Clinical Interview for DSM-5 Disorders). Repetitive Transcranial Magnetic Stimulation Intervention Group Inclusion Criteria: 1. Clinical diagnosis of schizophrenia according to ICD-11; 2. Confirmation of schizophrenia diagnosis via SCID-5-CV (Clinical Version of the DSM-5 Diagnostic and Statistical Manual Clinical Interview); 3. Any subscale score =4 on the Negative Symptom Scale of the PANSS. 4. Age < 60 years, disease duration < 10 years. Health control group inclusion criteria: 1. Age 13–60 years; 2. Does not meet clinical criteria for schizophrenia according to ICD-11; 3. Re-evaluated using SCID-5-CV (DSM-5 Diagnostic and Statistical Manual of Mental Disorders Clinical Version) and found not to meet criteria for schizophrenia.

Exclusion criteria

Exclusion criteria: Exclusion criteria for the schizophrenia cohort: 1. Clinically diagnosed with SCID-5-CV assessment meeting criteria for neurodevelopmental disorders, bipolar and related disorders, or substance use disorders (excluding alcohol and tobacco); 2. Presence of severe or acute somatic illness, including traumatic brain injury, intracranial space-occupying or infectious lesions, acute phase of cardiovascular or cerebrovascular disease, acute respiratory illness, acute haematological disorders, etc.; 3. Presence of confirmed genetic disorders, including tuberous sclerosis, multiple sclerosis, Kleefstra syndrome, 22q11.2 deletion syndrome, Prader-Willi syndrome, Klinefelter syndrome (47,XXY), etc. Exclusion Criteria for Repetitive Transcranial Magnetic Stimulation Intervention Group: 1. Clinically diagnosed with neurodevelopmental disorders, bipolar and related disorders, or substance use disorders (excluding alcohol and tobacco) according to SCID-5-CV assessment; 2. Presence of severe or acute somatic conditions, including traumatic brain injury, intracranial space-occupying or infectious diseases, acute phase of cardiovascular or cerebrovascular diseases, acute phase of respiratory diseases, acute phase of haematological diseases, etc.; 3. Presence of confirmed genetic disorders, including tuberous sclerosis, multiple sclerosis, Kleefstra syndrome, 22q11.2 deletion syndrome, Prader-Willi syndrome, Klinefelter syndrome (47,XXY), etc.; 4. Presence of metallic implants such as cardiac pacemakers or other contraindications for MRI examinations; presence of contraindications for TMS such as epilepsy, cochlear implants, or intracranial metallic implants; 5. History of severe self-harm or suicide attempts, or patients at risk of self-harm or suicide; 6. Other circumstances deemed unsuitable for participation in this clinical trial by the investigator. Exclusion criteria for healthy control group: 1. Clinically diagnosed with neurodevelopmental disorders, bipolar and related disorders, or substance use disorders (excluding alcohol and tobacco) according to SCID-5-CV assessment; 2. Presence of severe or acute somatic illnesses, including traumatic brain injury, intracranial space-occupying or infectious diseases, acute phase of cardiovascular or cerebrovascular diseases, acute phase of respiratory diseases, acute phase of haematological diseases, etc.; 3. Presence of confirmed genetic disorders, including tuberous sclerosis, multiple sclerosis, Kleefstra syndrome, 22q11.2 deletion syndrome, Prader-Willi syndrome, Klinefelter syndrome (47,XXY), etc.

Design outcomes

Primary

MeasureTime frame
Positive and Negative Syndrome Scale (PANSS) score;MATRICS Consensus Cognitive Battery (MCCB) test score;Positive and Negative Syndrome Scale (PANSS) score;Chinese Perceived Stress Scale (CPSS) score;Scale for Assessment of positive Symptoms (SAPS) score;Calgary Depression Scale for Schizophrenia (CDSS) score;Clinical Global Impression (CGI) Score;Scale for Assessment of Negative Symptoms (SANS) score;Scale for Assessment of Negative Symptoms (SANS) score;

Secondary

MeasureTime frame
Personal and Social Performance Scale (PSP) score;Changes in BMI and waist-to-hip ratio;SCID-5-CV (Structured Clinical Interview for DSM-5 Disorders, Clinical Version) score;Blood lipids;Complete blood count;High resolution T1 structural imaging, diffusion tensor imaging (DTI), and resting state functional magnetic resonance imaging (fMRI);Eye movement detection;Near-infrared brain functional imaging;Electroencephalography (EEG) data acquisition;hepatitis panel;liver and kidney function;Clinical Global Impression (CGI) score;Calgary Depression Scale for Schizophrenia (CDSS) score;fasting blood glucose, fasting insulin, glycated hemoglobin, and insulin resistance index;Montgomery-Asberg Depression Rating Scale (MADRS) score;Global Assessment of Functioning (GAF) score;Global Assessment of Functioning (GAF) score;Scale for Assessment of positive Symptoms (SAPS) score;SCL-90 (Symptom Checklist-90) self-report scale score;thyroid function tests;Personal and Social Performance Scale (PSP) score;

Countries

China

Contacts

Public ContactRenrong Wu

Second Xiangya Hospital of CSU

wurenrong2013@163.com+86 15874179855

Outcome results

None listed

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