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Trial record 1 of 1 for:    NCT00786318
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Ziprasidone vs Standard Therapy for Agitated Patients in the ED

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00786318
Recruitment Status : Withdrawn (Sponsor terminated)
First Posted : November 6, 2008
Last Update Posted : September 25, 2017
Information provided by:
George Washington University

Tracking Information
First Submitted Date  ICMJE November 5, 2008
First Posted Date  ICMJE November 6, 2008
Last Update Posted Date September 25, 2017
Study Start Date  ICMJE September 2008
Estimated Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 5, 2008)
length of time from triage until patient is either ready to be seen by psychiatry or is ready to have a disposition made [ Time Frame: During ED stay ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 5, 2008)
  • Length of time taken to sedate patient [ Time Frame: Ed visit ]
  • Total time spent in restraints [ Time Frame: ED visit ]
  • Cost effectiveness of the therapy [ Time Frame: ED visit ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
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 Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: September 12, 2017)
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2008)
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