A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation

Study Overview
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Brief Summary
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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

Official Title
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A Randomized, Open Label, Rater Blind, Flexible Dose Multi-Center Study Comparing The Efficacy And Safety Of Intramuscular Ziprasidone With Haloperidol For Three Days In Patients With Agitation Of Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Intramuscular ziprasidone mesylate
* Drug: Intramuscular haloperidol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Chinese subjects aged 18-65 years (including 65) at screening. Subjects meeting the ICD-10 (Classification of Mental and Behavioral Disorders) criteria for schizophrenia (F20.X). Subjects who are in acute phase of schizophrenia and are appropriate to receive intramuscular medication for at least 3 days Exclusion Criteria: History of clinically significant physical illness especially myocardial infarction, non compensatory heart failure etc. Subjects receiving an investigational agent in the previous 3 months prior to screening. Use of antipsychotic agents within 12 hours or parenteral benzodiazepines within 4 hours prior to randomization and during the study.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intramuscular ziprasidone<br> | Drug: Intramuscular ziprasidone mesylate<br>* 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.<br>* Other names: Zeldox, Geodon;|
| Active Comparator: Intramuscular haloperidol<br> | Drug: Intramuscular haloperidol<br>* 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.<br>* Other names: Haldol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | Baseline, 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intramuscular ziprasidone, agitation, efficacy and safety