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

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

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 Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Intramuscular ziprasidone mesylate; Drug: Intramuscular haloperidol

• Study Type: Interventional
• Enrollment (Actual): 376
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100083
    • Pfizer Investigational Site
  • Beijing, China, 100088
    • Pfizer Investigational Site
  • Chang Sha, China, 410011
    • Pfizer Investigational Site
  • Guangzhou, China, 510370
    • Pfizer Investigational Site
  • Nanjing, China, 210029
    • Pfizer Investigational Site
  • Xi'an, China
    • Pfizer Investigational Site
  • Hebei
    • Baoding, Hebei, China, 071000
      • Pfizer Investigational Site
  • Hubei
    • Wuhan, Hubei, China, 430060
      • Pfizer Investigational Site
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intramuscular ziprasidone	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.; Other Names: Zeldox, Geodon
Active Comparator: Intramuscular haloperidol	Drug: 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.; Other Names: Haldol

What is the study measuring?

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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Zhang H, Wang G, Zhao J, Xie S, Xu X, Shi J, Deng H, Li K, Gao C, Wang X, Vanderburg D, Pan S, Tang H, Shu L, Karayal ON. Intramuscular ziprasidone versus haloperidol for managing agitation in Chinese patients with schizophrenia. J Clin Psychopharmacol. 2013 Apr;33(2):178-85. doi: 10.1097/JCP.0b013e3182839612.

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: July 25, 2008
• First Submitted That Met QC Criteria: July 28, 2008
• First Posted (Estimate): July 29, 2008

Study Record Updates

• Last Update Posted (Actual): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Intramuscular ziprasidone, agitation, efficacy and safety
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Schizophrenia Spectrum and Other Psychotic Disorders; Dyskinesias; Psychomotor Disorders; Schizophrenia; Psychomotor Agitation; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Anti-Dyskinesia Agents; Ziprasidone; Haloperidol; Haloperidol decanoate
• Other Study ID Numbers: A1281152