Ziprasidone vs Standard Therapy for Agitated Patients in the ED

NCT00786318

Last updated date
Study Location
The George Washington University Medical Center, Dept of Emergency Medicine
Washington, D.C., District of Columbia, 20037, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psychosis, Agitation, Delirium
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-100 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Acutely agitated

- Requires chemical sedation

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Physician preference for a specific chemical sedative


- Known allergy to any study medications

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Psychosis, Agitation, DeliriumZiprasidone vs Standard Therapy for Agitated Patients in the ED
NCT00786318
  1. Washington, D.C., District of Columbia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Ziprasidone vs Standard Therapy for Agitated Patients in the ED
Official Title  ICMJE Prospective Double Blind Randomized Trial of Intramuscular Ziprasidone Compared With Standard Antipsychotic Therapy For The Treatment Of The Acutely Agitated Patient In The Emergency Department
Brief Summary The primary objective is to determine if ziprasidone is superior to standard therapies in the emergency department treatment of the acutely agitated patient. The primary outcome will be the length of time taken until the patient is ready to be evaluated by the psychiatric service, or until a disposition is made.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Psychosis
  • Agitation
  • Delirium
Intervention  ICMJE
  • Drug: ziprasidone
    ziprasidone 20mg IM
  • Drug: Standard therapy
    Haldol 5mg/ Ativan 2mg IM
Study Arms  ICMJE
  • Experimental: ziprasidone
    Intervention: Drug: ziprasidone
  • Active Comparator: Standard therapy
    Intervention: Drug: Standard therapy
Publications * Brown J. The spectrum of informed consent in emergency psychiatric research. Ann Emerg Med. 2006 Jan;47(1):68-74. Epub 2005 Nov 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 12, 2017)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2008)
300
Estimated Study Completion Date  ICMJE July 2011
Estimated Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Acutely agitated
  • Requires chemical sedation

Exclusion Criteria:

  • Physician preference for a specific chemical sedative
  • Known allergy to any study medications
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00786318
Other Study ID Numbers  ICMJE 010411 (completed)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeremy Brown, Dept of Emergency Medicine, The George Washington University Medical Center
Study Sponsor  ICMJE George Washington University
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account George Washington University
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP