Treatment-Resistant Schizophrenia
Conditions
Interventions
antipsychotic drug group:None
healthy control group:None
Sponsors
Shanghai Mental Health Center
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: magnetic seizure therapy group: 1. Meet the diagnostic criteria for schizophrenia according to the DSM-5, and be determined as having clinically treatment-resistant schizophrenia (TRS) by two senior psychiatrists; 2. Aged 18 to 55 years; 3. Positive and Negative Syndrome Scale >=60; 4. CGI >=4; 5. Written informed consent obtained from the subject and their legal guardian; antipsychotic drug group: 1.Meet the diagnostic criteria for schizophrenia according to the DSM-5, and be determined as having clinically treatment-resistant schizophrenia (TRS) by two senior psychiatrists;OR the patient/legal guardian declines MST and opts to receive antipsychotic medication only; 2. Aged 18 to 55 years; 3. PANSS >=60; 4. CGI >=4; 5. Written informed consent obtained from the subject and their legal guardian; healthy control group: Volunteers matched for age, sex, and education level with the patient group;
Exclusion criteria
Exclusion criteria: magnetic seizure therapy and antipsychotic drug group: 1. Diagnosis of psychiatric disorders other than schizophrenia based on the structural neuropsychiatric Interview, including bipolar and related disorders, depressive disorders, anxiety disorders, etc; 2. Having received electroconvulsive therapy (ECT) or magnetic seizure therapy (MST) within the past 6 months; 3. Presence of severe or unstable physical diseases (e.g., acute or chronic renal failure, liver cirrhosis, or active liver disease); 4. Clinically significant abnormal laboratory results(affect the safety of the subject); 5. Alcohol abuse within 30 days prior to the start of the trial, or a history of alcohol or substance dependence within 6 months prior to the trial; 6. Pregnant or lactating women, or women of childbearing potential with a positive urine human chorionic gonadotropin (HCG) test at screening; 7. Participation in any other clinical trial within 30 days prior to baseline; 8. Presence of contraindications for magnetic resonance imaging (MRI) (e.g., irremovable metal implants in the head); 9. Any other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in the study; healthy control group: 1. Any individuals with possible mental disorders based on a structured neuropsychiatric interview. 2. Family history of psychosis; 3. Presence of severe or unstable physical diseases (e.g., acute or chronic renal failure, liver cirrhosis, or active liver disease); 4. Clinically significant abnormal laboratory results(affect the safety of the subject); 5. Alcohol abuse within 30 days prior to the start of the trial, or a history of alcohol or substance dependence within 6 months prior to the trial; 6. Pregnant or lactating women, or women of childbearing potential with a positive urine human chorionic gonadotropin (HCG) test at screening; 7. Participation in any other clinical trial within 30 days prior to baseline; 8. Presence of contraindications for magnetic resonance imaging (MRI) (e.g., irremovable metal implants in the head); 9. Any other conditions that, in the opinion of the investigator, make the subject unsuitable for participation in the study;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Volume of the hippocampus and its subfields;NDI in the hippocampus and its subfields;Cerebral blood flow (CBF) in the hippocampus and its subfields; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive and Negative Syndrome Scale, PANSS;FA, MD, AD, RD ;Delta(1-4Hz), Theta (4-8Hz), Alpha(8-13Hz), Beta(13-30Hz), Gamma(30-100Hz) ;Other parameters of NODI sequence: Directional Dispersion (ODI) and Isotropic Volume Fraction (Fiso); | — |
Countries
China
Contacts
Public ContactLi Chunbo
Shanghai Mental Health Center
Outcome results
None listed