A Phase 2/3 interventional study of Intramuscular Haloperidol and Intramuscular Levosulpiride in Agitation, sponsored by Shanghai Mental Health Center. Completed at 5 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-12-03.
Sponsored by Shanghai Mental Health Center · Phase 2/3, Interventional, and Treatment
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 ]
500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.
This study's planned enrollment of 240 is above the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.
Browse Psychomotor Agitation studies →Shanghai Mental Health Center is the lead sponsor of 267 studies on the registry; 93 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Intramuscular Levosulpiride
Drug: Intramuscular Levosulpiride
Intramuscular Haloperidol
Drug: Intramuscular Haloperidol
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.
Also known as: Intramuscular Haloperidol parenteral solution
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.
Also known as: Intramuscular Levosulpiride parenteral solution
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)
This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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Shanghai Mental Health Center