Agitation Clinical Trial
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
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.
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,
AEćRating 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 ]
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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