The Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation

1. Trial Design:This is a multi-center, open-labeled, intervention study. 2. STUDY EVALUATION：1)Primary efficacy endpoint：The change of BARS total scores from baseline to the endpoint.2)Secondary efficacy endpoint： * The change of CGI-S from baseline to the endpoint * The change of BARS/CGI-S/CGI-I from baseline to every visit * The percentage of response at the end of 2h(BARS decreased score\>=2) * Subgroup analysis:(1)Comparison of the difference of the reduction in BARS/CGI-S in the different diseases subgroup.(2)Comparison of the difference of the reduction in BARS/CGI-S in the first episode and multi-episode patients.(3)Comparison of the difference of the reduction in BARS/CGI-S in the different previous antipsychotic treatment.(4)Comparison of the difference of disease categories, dosage, duration, and the reduction in BARS/CGI-S in the monotherapy and combination with other oral antipsychotic drugs Safety evaluation 3)Include adverse events, ECG(the change rate of ECG and the average change of QT),vital signs from the baseline to the endpoint. 1. The change of Simpson-Angus with from the baseline to endpoint. 2. The incidence of ADR、extrapyramidal symptoms、tachycardia during the studyThe incidence of during the study. 3. STUDY DRUGS:The injection mesylate ziprasidone used in this study have been marketed, manufactured by Pfizer and provided study drug for research purposes.Strength:Each vial contains Ziprasidone 30 mg, Sulfobutyl betadex sodium 441 mg. When reconstituted as directed the solution for injection contains the equivalent of 20 mg per mL of Ziprasidone.Ziprasidone intramuscular is intended for intramuscular use only and should not be administered intravenously. 4. DATA ADMINISTRATION AND STATISTICAL METHODS:The case report form (CRF) used in this clinical study is in paper form. The data and statistical analysis collected in study will be recorded in the statistical analysis program (SAP). 5. Basic principles of research design:Collecting the safety, effectiveness indexes in the process of drug treatment, analysis the changes before and after 3 days of the treatment, and record injection in the process of the study, in order to analyze the safety and efficacy of injection ziprasidone in the real clinical practice.