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

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Intramuscular ziprasidone mesylate; Drug: Intramuscular haloperidol

• Registration Number: NCT00723606
• Lead Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-28
• Study First Posted: 2008-07-29
• Study Start: 2008-09
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Results First Submitted: 2010-07-29
• Results First Submitted QC: 2010-07-29
• Results First Posted: 2010-08-25
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-02
• Last Update Posted: 2021-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 376

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intramuscular ziprasidone	Intramuscular ziprasidone mesylate	-
Intramuscular haloperidol	Intramuscular haloperidol	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
BPRS Agitation Subscale Response at 72 Hours	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.
Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours	Baseline, 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.
Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours	Baseline, 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.
Change From Baseline in BPRS Agitation Subscale Score at 72 Hours	Baseline, 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.
Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇳 Xi'an, China