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

Schizophrenia Clinical Trial

Official title: A Multi-Center,Open-Labeled,Intervention Study:The Efficacy And Safety Of Intramuscular Ziprasidone For Three Days In Patients With Psychotic Agitation

Status Not yet recruiting

Clinical Trial Summary

1. The title of this study is a multi-center,non randomized,open-labeled,intervention study:the efficacy and safety of intramuscular ziprasidone for three days in patients with acute psychotic agitation.

2. The primary objectiveis to evaluate the efficacy of intramuscular ziprasidone in patients with acute psychotic agitation in daily clinical practice.

3. The secondary objectives are:1.To evaluate the safety of intramuscular ziprasidone in patients with acute psychotic agitation in daily clinical practice.2.To compare the efficacy and tolerance of intramuscular ziprasidone in patients with agitation in the different psychotic disorder 3.To compare the efficacy and tolerance of intramuscular ziprasidone in patients with first episode andmulti-episode patients. 4.To explore the measured based administration according to severity of symptoms.5.To compare the efficacy and tolerance of ziprasidone im between the monotherapy and combination with other antipsychotic drug in clinical practice.

4. The Rationale:In China, the studies of ziprasidone im treating agitation focus on schizophrenia. But in the foreign country, ziprasidone im also is approved to treat psychotic agitation, including bipolar and schizoaffective disorder. And in the clinical practice of China, ziprasidone im is also used to treat other patients, although the evidence is less. In this study, we assume ziprasidone im treat the psychotic agitation is effective and safe.

5. Study populations:The study plan to enroll 1000 subjects in China. （6）The background and the hypothesis：The researches of ziprasidone mesylate injection in our country are more concentrated in schizophrenia at present, while in foreign countries ziprasidone is approved for psychotic agitation, including mania etc. It's also used for substance abuse and alcohol induced agitation.Therefore, this study assumes that ziprasidone mesylate injection is effective in the treatment of acute agitation, and it's well tolerated.

Clinical Trial Description

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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Schizophrenia

• NCT number: NCT02935998
• Study type: Interventional
• Source: Beijing HuiLongGuan Hospital
• Contact: Yang Fude, director
• Phone: +8613651336121
• Email: yangfd200@126.com
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 2016
• Completion date: December 2017