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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00723606
First received: July 25, 2008
Last updated: August 24, 2010
Last verified: August 2010
  Purpose

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 Intervention Phase
Schizophrenia
Drug: Intramuscular ziprasidone mesylate
Drug: Intramuscular haloperidol
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Brief Psychiatric Rating Scale (BPRS) Total Scores at 72 Hours [ Time Frame: Baseline, 72 hours ] [ Designated as safety issue: No ]
    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:
  • BPRS Agitation Subscale Response at 72 Hours [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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 BPRS Agitation Subscale Score at 72 Hours [ Time Frame: Baseline, 72 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Clinical Global Impressions Severity (CGI-S) Score at 72 Hours [ Time Frame: Baseline, 72 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline, 72 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 376
Study Start Date: September 2008
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00723606

Locations
China, Hebei
Pfizer Investigational Site
Baoding, Hebei, China, 071000
China, Hu Nan
Pfizer Investigational Site
Chang Sha, Hu Nan, China, 410011
China, Hubei
Pfizer Investigational Site
Wuhan, Hubei, China, 430060
China, Yunnan
Pfizer Investigational Site
Kunming, Yunnan, China, 650032
China
Pfizer Investigational Site
Beijing, China, 100088
Pfizer Investigational Site
Beijing, China, 100083
Pfizer Investigational Site
Guangzhou, China, 510370
Pfizer Investigational Site
Nanjing, China, 210029
Pfizer Investigational Site
Xi'an, China
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00723606     History of Changes
Other Study ID Numbers: A1281152
Study First Received: July 25, 2008
Results First Received: July 29, 2010
Last Updated: August 24, 2010
Health Authority: China: Ministry of Health
China: Food and Drug Administration

Keywords provided by Pfizer:
Intramuscular ziprasidone, agitation, efficacy and safety

Additional relevant MeSH terms:
Schizophrenia
Psychomotor Agitation
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Psychomotor Disorders
Neurobehavioral Manifestations
Signs and Symptoms
Haloperidol
Haloperidol decanoate
Ziprasidone
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
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

ClinicalTrials.gov processed this record on July 20, 2014