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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00723606
• Other study ID #: A1281152
• Status: Completed
• Phase: Phase 3
• Start date: September 2008
• Est. completion date: July 2009

Study information

• Verified date: March 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 376
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psychomotor Agitation
• Schizophrenia

Intervention

Drug:
• Intramuscular ziprasidone mesylate
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.
• Intramuscular haloperidol
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.

Locations

Country	Name	City	State
China	Pfizer Investigational Site	Baoding	Hebei
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Beijing
China	Pfizer Investigational Site	Chang Sha
China	Pfizer Investigational Site	Guangzhou
China	Pfizer Investigational Site	Kunming	Yunnan
China	Pfizer Investigational Site	Nanjing
China	Pfizer Investigational Site	Wuhan	Hubei
China	Pfizer Investigational Site	Xi'an

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   To obtain contact information for a study center near you, click here.