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

NCT00723606 | Completed Phase 3 Results

• 1 other identifier: A1281152
• Study Type: interventional
• Target: 376
• Locations: 1 country
• Sites: 9

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

Conditions

Schizophrenia

Keywords

Intramuscular ziprasidone, agitation, efficacy and safety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• BPRS Agitation Subscale Response at 72 Hours

  72 hours

• Change From Baseline in BPRS Agitation Subscale Score at 72 Hours

  Baseline, 72 hours

• Clinical Global Impression-Improvement (CGI-I) Score at 72 Hours

  72 hours

• Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours

  Baseline, 72 hours

• Change From Baseline in Behavioral Activity Rating Scale (BARS) at 72 Hours

  Baseline, 72 hours

Study Arms (2)

Intramuscular ziprasidone

EXPERIMENTAL

Drug: Intramuscular ziprasidone mesylate

Intramuscular haloperidol

ACTIVE COMPARATOR

Drug: Intramuscular haloperidol

Interventions

Intramuscular ziprasidone mesylate DRUG

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.

Also known as: Zeldox, Geodon

Intramuscular ziprasidone

Intramuscular haloperidol DRUG

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.

Also known as: Haldol

Intramuscular haloperidol

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (9)

Pfizer Investigational Site

Baoding, Hebei, 071000, China

Location

Pfizer Investigational Site

Wuhan, Hubei, 430060, China

Location

Pfizer Investigational Site

Kunming, Yunnan, 650032, China

Location

Pfizer Investigational Site

Beijing, 100083, China

Location

Pfizer Investigational Site

Beijing, 100088, China

Location

Pfizer Investigational Site

Changsha, 410011, China

Location

Pfizer Investigational Site

Guangzhou, 510370, China

Location

Pfizer Investigational Site

Nanjing, 210029, China

Location

Pfizer Investigational Site

Xi'an, China

Location

Related Publications (1)

• 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.

  PMID: 23422376 DERIVED

Related Links

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

MeSH Terms

Conditions

Schizophrenia; Psychomotor Agitation

Interventions

ziprasidone; Haloperidol

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2008
• First Posted: July 29, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: March 3, 2021
• Results First Posted: August 25, 2010

Record last verified: 2021-03

Locations

CN (9)