Schizophrenia
Conditions
Interventions
Long Waiting Group A:Clozapine treatment
Short Waiting Group B:Clozapine treatment
Sponsors
Peking University Sixth Hospital ( Institute of Mental Health )
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1.Outpatient and inpatient patients; 2.Diagnosed with F20 schizophrenia in the International Statistical Classification of Diseases and Related Health Issues, 10th edition (ICD-10); 3.Age range from 18 to 60 years old; 4.The patient meets the TRRIP criteria for refractory schizophrenia: current PANSS score >= 70 and at least 2 items on the positive symptom subscale score>= 4; And have previously used two or more antipsychotic drugs (chlorpromazine equivalent dose >= 600mg/d) for treatment, but have not achieved sufficient efficacy after more than 12 weeks of treatment; 5.The subjects and their guardians are able to understand the interview content and sign written informed consent;
Exclusion criteria
Exclusion criteria: 1.Additional diagnosis of neurological and psychiatric disorders, other neurological disorders including epilepsy, intellectual disability, and multiple sclerosis; 2.Previous alcohol/drug dependence or abuse; 3.Previous history of significant physical illnesses; 4.Women who have a need for pregnancy preparation or are already in pregnancy; 5.There are contraindications to clozapine treatment; 6.There are contraindications for magnetic resonance imaging examination; 7.Previously received treatment with clozapine; 8.Received electroconvulsive or long-acting injection treatment in the past 3 months; 9.There are currently clinically significant laboratory tests or test results that are not suitable for receiving treatment with clozapine; 10.Currently using somatic drugs that have central nervous system side effects and non central nervous system indications, as well as somatic drugs that affect the immune system, including glucocorticoids, anti-inflammatory/immunomodulatory drugs, and antibiotics; 11.The researcher determines that it is not suitable for participants in this clinical trial;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severity of symptoms;Interleukin-1ß;Interleukin-2;Interleukin-6;Interleukin-10;Glutamine Level in anterior cingulate cortex;Head magnetic resonance imaging structural phase indicators;Resting-state functional connectivity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Severity of negative symptoms;Severity of anhedonia;Decision making process;Social Functioning;neurocognition;Severity of suicide;Side-effects of antipsychotics;Medication adherence;Electrocardiogram, ECG;Cardiac Biomarkers;Blood routine and C-reactive protein;Urine human Chorionic Gonadotropin test;Clozapine Blood Concentration;Liver Function Tests;Urinalysis; | — |
Countries
China
Contacts
Public ContactYu Xin
Peking University Sixth Hospital ( Institute of Mental Health )
Outcome results
None listed