Schizophrenia
Conditions
Interventions
TR:Delivery order: TR
RT:Delivery order: RT
Sponsors
The Second Xiangya Hospital of Central South University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age range: >= 18 years old, male or female; 2. Conforming to DSM-5 criteria for schizophrenia; 3. Subjects have taken a stable dose of clozapine for up to 3 months at a daily dose of 150 to 350 mg and are able to tolerate 100 mg every 12 hours during the study; 4. Female subjects must meet one of the following conditions: -Menopause (at least one year); -Surgical sterilization (hysterectomy, bilateral oophorectomy or tubal ligation, or infertility); -Use of non-pharmacological contraceptive methods throughout the study; 5. The result of the blood pregnancy test was negative at the time of screening for women of childbearing age; 6. Male subjects must agree to use non-pharmaceutical contraception and not to donate sperm during the study; 7. The subject or his/her legal guardian can communicate well with the investigator, understand and comply with the requirements of the study, and understand and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. DSM-5 diagnosis of active substance dependence (nicotine and caffeine-free) within 6 months prior to screening; 2. Currently suffering from any serious or unstable cardiovascular, respiratory, neurological (including epilepsy or major cerebrovascular), renal, hepatic, blood, endocrine (including uncontrolled diabetes), immune or other system diseases, encephalopathy syndrome, central nervous system depression, bone marrow depression, urinary retention, glaucoma, mild to moderate or severe mental retardation, The presence can lead to prolongation of the QT interval, risk factors for torsade de pointes or stenosis; 3. ECG, vital signs, physical examination or laboratory test items are abnormal and the doctor considers it is not suitable to participate in the study; 4. Those who donated blood or lost a large amount of blood (>= 200 mL), received blood transfusion or used blood products within 3 months before the test; 5. The presence of evidence of clinically significant liver disease (including aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than twice the upper limit of the laboratory reference range) at the time of screening physical examination; 6. The subject's white blood cell count or the absolute value of neutrophils is lower than the lower limit of the laboratory reference range during screening physical examination; 7. Have a concurrent major psychiatric or neurological diagnosis, including organic mental disorder, severe tardive dyskinesia, or congenital Parkinson's disease; 8. History of granulocytopenia or myeloproliferative disease (drug-induced or congenital); history of severe orthostatic hypotension; 9. Women who are pregnant, breast-feeding or plan to become pregnant within 6 months; 10. Use of any drug that inhibits or induces hepatic metabolism of the drug within 30 days prior to the study (e.g., inducer barbiturates, carbamazepine, phenytoin, glucocorticoids, omeprazole; Inhibitors-SSRI antidepressants, cimetidine, diltiazem, macrolides, nitroimidazoles, sedative hypnotics, verapamil, fluoroquinolones, antihistamines, ketoconazole; except for drugs that have been taken for a long time and are planned to be used steadily during clinical trials); 11. Those who have ingested grapefruit or grapefruit-related citrus fruits (such as lime, grapefruit), star fruit, papaya, pomegranate or the above fruit products within 14 days before the test: 12. Significant smoking and drinking habits within 1 year before the test (smoking > 20 cigarettes per day; drinking more than 14 units of alcohol per week, 1 unit >= 200 mL of 5% alcohol beer or 25 mL of 40% alcohol spirits or 85 mL of 12% alcohol wine): 13. Known or suspected allergy or intolerance to clozapine or any of its excipients; 14. Previous life-threatening allergic reaction to drugs or food; 15. Previous use of the following prohibited therapies:-Use of antipsychotic long-acting injection before screening, and the last dose is within 5 half-lives of the screening period; -Non-selective/irreversible monoamine oxidase inhibitor antidepressants within 30 days prior to screening; 16. Participated in other clinical studies within 3 months of screening; 17. An employee of the investigator or the study site (directly involved in the study or other research conducted under the direction of the investigator or the study site), or a dependent of an investigator or employee; 18. The subject may not be able to complete the
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clozapine in plasma; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety; | — |
Countries
China
Contacts
Public ContactPingfei Fang
The Second Xiangya Hospital of Central South University
Outcome results
None listed