Schizophrenia
Conditions
Interventions
experimental group:Ziprasidone Mesylate for Injection Combined With Olanzapine, Aripiprazole
control group:Ziprasidone Mesylate for Injection Sequential Olanzapine, Aripiprazole, Ziprasidone
Sponsors
Xi'an Mental Health Center
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Subjects or/and legal representatives signed written informed consent form; 2. Subjects aged 18-50 years when signing written informed consent form; 3. Subjects met the diagnostic criteria for schizophrenia (F20.X) in ICD-10 (The International Statistical Classification of Diseases and Related Health Problems 10th Revision); 4. Subjects met all of the following criteria at baseline visit to show that the subject was in acute agitation period of schizophrenia; the total score of Positive and Negative Syndrome Scale (PANSS) =70; the total score of 5 items of Positive and Negative Syndrome Scale - Excited Component (PANSS-EC, P4 Excitement, P7 Hostility, G4 Tension, G8 Uncooperativeness, G14 Poor impulse control) =14 (1-7 point system), and at least one score of item =4.
Exclusion criteria
Exclusion criteria: 1. Subjects received antipsychotics within the previous 1 week prior to screening; 2. Female subjects during pregnancy or lactation, or who have recently planned pregnancy; 3. Subjects who met the diagnostic criteria for substance abuse in ICD-10 (The International Statistical; Classification of Diseases and Related Health Problems 10th Revision) within 6 months prior to the screening visit, including alcohol abuse; 4. Subjects with a history of symptomatic hypotension or orthostatic hypotension; 5. Subjects with a history of ischemic heart disease or myocardial infarction, heart failure, angioplasty, stent implantation or coronary artery bypass surgery; 6. Electrocardiogram (ECG) results: subjects with an ECG interval = 450 ms (male) or = 470 ms (female); 7. Subjects with brain organic mental disorders, including mental retardation, elderly psychiatric patients associated with dementia, epilepsy (except for single seizures, such as fecal seizures in childhood, seizures after trauma or after alcohol withdrawal), cerebrovascular diseases, etc.; 8. Subjects with severe organic diseases or medical history of important organs (including but not limited to: liver, kidney, respiratory, cardiovascular, endocrine, neurological, hematological or immunological diseases); 9. Subjects with a history of increased intraocular pressure or glaucoma; 10. Subjects with abnormal electrolytes during screening; 11. Subjects with dehydration and hypovolemia during screening; 12. Subjects who used long-acting antipsychotics within the previous 4 weeks prior to screening; 13. Subject received electroconvulsive therapy within 4 weeks prior to the signing of the informed consent form; 14. Subjects with a history of psychiatric surgery; 15. Subjects with physical disease medications taken during screening may cause QTc prolongation; 16. Subjects with a history of neuroleptic syndrome (NMS); 17. Subjects with a history of allergies to liningone, olanzapine, and aripiprazole.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PANSS-EC; | — |
Secondary
| Measure | Time frame |
|---|---|
| PANSS;CGI;TESS;RESES;Barnes; | — |
Countries
China
Contacts
Public ContactMeng Cui
Xi'an Mental Health Center
Outcome results
None listed