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, AE、Rating Scale for Extrapyramidal Side Effect(RSESE) and Barnes Akathisia Scale(BAS)from baseline to the end of study (Time Frame: 72 hours) \[ Designated as safety issue: Yes \]
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
240
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.
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.
Hebei Mental Health Center
Baoding, Hebei, China
Nanjing Brain Hospital
Nanjing, Jiangsu, China
Xi'an Mental Health Center
Xi'an, Shaanxi, China
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, China
the change of PANSS-EC total scores
Time frame: from baseline to the end of study(72 hours after first dosing)
the change of Agitation Calmness Evaluation Scale(ACES)
Time frame: 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)
Time frame: from baseline to the end of study (72 hours after first dosing)
the change of PANSS total scores
Time frame: from baseline to the end of study (72 hours after first dosing)
the change of Brief Psychiatric Rating Scale(BPRS) total scores
Time frame: from baseline to the end of study (72 hours after first dosing)
the change of every item of PANSS-EC
Time frame: from baseline to the end of study (72 hours after first dosing)
the change of Rating Scale for Extrapyramidal Side Effect(RSESE)
Time frame: from baseline to the end of study (72 hours after first dosing)
the change of Barnes Akathisia Scale(BAS)
Time frame: from baseline to the end of study (72 hours after first dosing)
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The First Affilliated Hospital Of Kunming Medical College
Kunming, Yunnan, China