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

• ClinicalTrials.gov Identifier: NCT00723606
• Recruitment Status: Completed
• First Posted: July 29, 2008
• Results First Posted: August 25, 2010
• Last Update Posted: March 3, 2021
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Information provided by (Responsible Party): Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Study Description

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

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: Intramuscular ziprasidone mesylate; Drug: Intramuscular haloperidol	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 376 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: September 2008
• Actual Primary Completion Date: July 2009
• Actual Study Completion Date: July 2009

Arms and Interventions

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 Name: 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 Name: Haldol

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours [ Time Frame: 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 :

1. BPRS Agitation Subscale Response at 72 Hours [ Time Frame: 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.
2. Change From Baseline in BPRS Agitation Subscale Score at 72 Hours [ Time Frame: 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.
3. Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours [ Time Frame: 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.
4. Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours [ Time Frame: 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.
5. Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours [ Time Frame: 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.

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

China, Hebei

Pfizer Investigational Site

Baoding, Hebei, China, 071000

China, Hubei

Pfizer Investigational Site

Wuhan, Hubei, China, 430060

China, Yunnan

Pfizer Investigational Site

Kunming, Yunnan, China, 650032

China

Pfizer Investigational Site

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

Sponsors and Collaborators

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

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

More Information

Additional Information:

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• ClinicalTrials.gov Identifier: NCT00723606
• Other Study ID Numbers: A1281152
• First Posted: July 29, 2008
• Results First Posted: August 25, 2010
• Last Update Posted: March 3, 2021
• Last Verified: March 2021

Keywords provided by Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. ):

Intramuscular ziprasidone, agitation, efficacy and safety

Additional relevant MeSH terms:

Psychomotor Agitation; Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Haloperidol; Haloperidol decanoate; Ziprasidone; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Dopamine Antagonists; Dopamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Dyskinesia Agents; Serotonin Antagonists; Serotonin Agents