A Study To Evaluate The Efficacy And Safety Of Intramuscular Levosulpiride In Patients With Agitation Of Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the efficacy and safety of Intramuscular Levosulpiride in the treatment of Chinese patients with Agitation Of Schizophrenia compared with Intramuscular Haloperidol by evaluating the change of PANSS-EC total scores at end of study (72 hours after first dosing) from baseline.

Detailed Description
-----------------
Secondary Outcome Measures: To evaluate the change of Agitation Calmness Evaluation Scale(ACES), Clinical Global Impression(CGI, including CGI-S and CGI-I),PANSS total scores,Brief Psychiatric Rating Scale(BPRS) total scores and every item of PANSS-EC from baseline to the end of study (Time Frame: 72 hours) [ Designated as safety issue: No ] To evaluate the change of patients' main complain, physical examination, lab and ECG tests, AE、Rating Scale for Extrapyramidal Side Effect(RSESE) and Barnes Akathisia Scale(BAS)from baseline to the end of study (Time Frame: 72 hours) [ Designated as safety issue: Yes ]

Official Title
-----------------
A Randomized Blind Parallel Intramuscular Haloperidol-Controlled Multicenter Clinical Trial to Evaluate the Efficacy and Safety of Intramuscular Levosulpiride in the Treatment of Chinese Patients With Agitation Of Schizophrenia

Conditions
-----------------
Agitation

Intervention / Treatment
-----------------
* Drug: Intramuscular Haloperidol
* Drug: Intramuscular Levosulpiride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Chinese inpatients(are required to stay at hospital during the study) aged 18-65 years Patients meeting the DSM-IV criteria for schizophrenia or schizophreniform psychosis Agitated with a minimum total score of ≧ 15 on the five items of the PANSS-EC and at least one individual item score of ≧ 5 or two item score of ≧ 4 using the 1-7 scoring system ACES≤3 Written informed consent provided by patients' legal representative Exclusion Criteria: Investigator and his/her relatives Participation in another drug trial within 3 months prior enrolment into this study Female patients during their pregnant and lactation period Any currently severe unstable medical illness or disease would affect assessment for this study, including epilepsy, angle closure glaucoma, disease of liver, kidney, gastrointestinal tract, respiratory system, cardiovascular system(including Ischemic Heart Disease), endocrine system, nervous system, immune or hematological system etc. A significantly clinical abnormal value in ECG or lab results,ALT and AST values in the liver function test exceeding two times of the upper limits of normal values, urea nitrogen value arising up to 1.2 times of the upper limits of normal values, creatinine or serum potassium exceeding normal values With a family history of sudden death Meet the DSM-IV criteria for substance abuse within 1 year prior enrolment Regularly use antipsychotics(clozapine within 90 days), antidepressants, mood stabilizers, anti-epileptics or prolonged-action preparations within 2 weeks prior enrolment Use of Electroconvulsive therapy within 30 days prior enrolment Systematically use of sulpiride, levosulpiride or haloperidol therapy within 30 days prior enrolment History of or current neuroleptic malignant syndrome, severe EPS, significant tardive dyskinesia Severe suicide attempt Known hypersensitivity to sulpiride, levosulpiride or haloperidol, or history of severe drug hypersensitivity or hypersensitivity to more than 2 drugs Use of psychotropics(except permitted drugs) within 12 hours prior enrolment Known lack of efficacy to levosulpiride or haloperidol by formal treatment before Organic mental disorders, including Mental retardation History of psychosurgery treatment Patients can not comply with study protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Intramuscular Levosulpiride | Drug: Intramuscular Levosulpiride<br>* 2ml：50mg/ampoul the recommended dose is 100 mg per day administered. Doses of 100 mg may be administered 50mg bid with an interval longer than 4 hours for 3 days.<br>* Other names: Intramuscular Levosulpiride parenteral solution;|
| Active Comparator: 2<br>Intramuscular Haloperidol | Drug: Intramuscular Haloperidol<br>* 1ml：5mg/ampoul the recommended dose is 10 mg per day administered. Doses of 10 mg may be administered 5mg bid with an interval longer than 4 hours for 3 days.<br>* Other names: Intramuscular Haloperidol parenteral solution;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of PANSS-EC total scores |  | from baseline to the end of study(72 hours after first dosing) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the change of Agitation Calmness Evaluation Scale(ACES) |  | from baseline to the end of study (72 hours after first dosing) | 
| The Change of Clinical Global Impression(CGI, including CGI-S and CGI-I) |  | from baseline to the end of study (72 hours after first dosing) | 
| the change of PANSS total scores |  | from baseline to the end of study (72 hours after first dosing) | 
| the change of Brief Psychiatric Rating Scale(BPRS) total scores |  | from baseline to the end of study (72 hours after first dosing) | 
| the change of every item of PANSS-EC |  | from baseline to the end of study (72 hours after first dosing) | 
| the change of Rating Scale for Extrapyramidal Side Effect(RSESE) |  | from baseline to the end of study (72 hours after first dosing) | 
| the change of Barnes Akathisia Scale(BAS) |  | from baseline to the end of study (72 hours after first dosing) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Agitation, Schizophrenia, Randomized, Blind, Parallel, Intramuscular Haloperidol, Controlled, Multicenter, Clinical Trial, Efficacy, Safety, Intramuscular Levosulpiride, Chinese, PANSS-EC, ACES, CGI, BPRS, PANSS, RSESE, BAS