This local registration study is to confirm the hypothesis of the efficacy, tolerability and safety of ziprasidone IM (intramuscular) in the Chinese population with agitation in schizophrenia
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
376
The recommended dose is 10 to 20 mg administered as required up to a maximum dose of 40 mg per day. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day for 3 days.
The haloperidol group will receive an initial intramuscular injection of haloperidol 5mg, following on which 5mg haloperidol may be repeated every 4-8 hours to a maximum of 20 mg /day for 3 days.
Pfizer Investigational Site
Baoding, Hebei, China
Pfizer Investigational Site
Wuhan, Hubei, China
Pfizer Investigational Site
Kunming, Yunnan, China
Pfizer Investigational Site
Beijing, China
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours
BPRS is an 18-item clinician rated scale with 11 general symptom items, 5 positive-symptom items, and 2 negative symptom items scored on a 7-point scale (1=not present and 7=extremely severe), with higher score indicating greater severity of symptom. Total possible score range=18 to 126. Change: score at final visit minus score at baseline.
Time frame: Baseline, 72 hours
BPRS Agitation Subscale Response at 72 Hours
The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. A response was defined as a \> 30 percent reduction from baseline in BPRS agitation subscale score.
Time frame: 72 hours
Change From Baseline in BPRS Agitation Subscale Score at 72 Hours
The BPRS agitation subscale score was composed of 4 questions (questions 2, 6, 10, 17). The BPRS agitation subscale score was obtained by summing the relevant individual items. Total possible score range=4 to 28. Change: score at final visit minus score at baseline.
Time frame: Baseline, 72 hours
Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours
CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved), 2 (much improved), or 3 (minimally improved) on the scale. Higher score = more affected.
Time frame: 72 hours
Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours
CGI-S: 7-point clinician rated scale to assess severity of subject's current illness state; range: 1 (normal - not ill at all) to 7 (among the most extremely ill patients). Higher score = more affected. Change: score at observation minus score at baseline.
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Pfizer Investigational Site
Beijing, China
Pfizer Investigational Site
Changsha, China
Pfizer Investigational Site
Guangzhou, China
Pfizer Investigational Site
Nanjing, China
Pfizer Investigational Site
Xi'an, China
Time frame: Baseline, 72 hours
Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours
BARS measures the degree of agitated behavior using a 7-point scale describing increasing levels of activity (1 =difficult or unable to rouse; 2 = asleep but responds normally to verbal or physical contact; 3 = drowsy, appears sedated; 4 = quiet and awake \[normal level of activity\]; 5 = signs of overt \[physical or verbal\] activity, calms down with instructions; 6 = extremely or continuously active, not requiring restraint; 7 = violent, requires restraint.
Time frame: Baseline, 72 hours