schizophrenia
Conditions
Interventions
Sponsors
The Seventh People's Hospital of Shaoxing City
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meeting the diagnostic standards of DSM-IV on schizophrenia; 2. Men or women aged between 18 and 65 years; 3. The total score of PANSS = 70; 4. normal liver function,Glucose and lipid metabolism and the QT interval; 5. never used antipsychotic drugs or stop use antipsychotic drugs at least 2weeks; 6.If patients were treated with other drugs due to body diseases, the service drugs have to be taken regularly more than or equal to 3 months and no induced liver function damage history; 7. Female subjects must meet one of the following conditions: (1) Menopause (at least one year); (2) Surgical sterilization (received hysterectomy, Bilateral ovariectomy or tubal ligation, or automatic infertility); (3) Agree to use effective means of contraception before and throughout the course of the study. 8. Urine pregnancy test of women on childbearing age were negative when screening; 9. Male subjects having sexual life with women on childbearing age must agree to use double barrier contraception and not to donate sperm during the study period as well as 3 months after receiving the last dose of the study medication; 10. Patients or their legal representatives must be aware of the contents of this study and signed written informed consent; 11. No serious or unstable body disease.
Exclusion criteria
Exclusion criteria: 1. Not meeting the diagnostic standards of DSM-IV on schizophrenia; 2. History of alcohol and drug dependence; 3. Attempt to suicide or have serious tendency to commit suicide or violent behavior within 12 months before screening; 4. Past or present suffering from any serious or unstable body disease; 5. History of blood transfusion and drinking, Liver and gallbladder diseases caused by acute viral hepatitis , etc.; 6. Other drug induced liver damage; 7. Past suffering from Nerve blocker Malignant Syndrome (NMS) or delayed motor disorder; 8. Women in pregnancy and lactation, or planning to become pregnant within 6 months; 9. Past or present use of clozapine to treat refractory schizophrenia; 10. Drug resistance history of Risperidone, Paliperidone or Olanzapine, which was defined as no response after 2 cycles of adequate dose treatment(at least 4 weeks with a treatment that is above the minimum dose range); 11. Known or suspected to have an allergy or intolerance on Paliperidone,Olanzapine or any of their excipients; 12. Receiving Electro shock therapy (ECT) within 30 days before screening; 13. Receiving other clinical trials within 30 days before screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALT;AST;ALT;CB;TB; | — |
Secondary
| Measure | Time frame |
|---|---|
| weight;body mass index;waistline;blood pressure;fasting blood-glucose;fasting insulin;glycohemoglobin A1;cholesterol;triglycerides;high density level cholesterol ;low density level cholesterol ;QT interval; | — |
Countries
China
Contacts
Public ContactDONG Yingying
The Seventh People's Hospital of Shaoxing City
Outcome results
None listed