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Recruitment Status : Withdrawn (Sponsor terminated)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

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.

Condition or disease Intervention/treatment Phase
Psychosis Agitation Delirium Drug: ziprasidone Drug: Standard therapy Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2008
Estimated Primary Completion Date : July 2011
Estimated Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: ziprasidone Drug: ziprasidone
ziprasidone 20mg IM
Active Comparator: Standard therapy Drug: Standard therapy
Haldol 5mg/ Ativan 2mg IM

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Length of time taken to sedate patient [ Time Frame: Ed visit ]
  2. Total time spent in restraints [ Time Frame: ED visit ]
  3. Cost effectiveness of the therapy [ Time Frame: ED visit ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Acutely agitated
  • Requires chemical sedation

Exclusion Criteria:

  • Physician preference for a specific chemical sedative
  • Known allergy to any study medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00786318

United States, District of Columbia
The George Washington University Medical Center, Dept of Emergency Medicine
Washington, D.C., District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University

Responsible Party: Jeremy Brown, Dept of Emergency Medicine, The George Washington University Medical Center Identifier: NCT00786318     History of Changes
Other Study ID Numbers: 010411 (completed)
First Posted: November 6, 2008    Key Record Dates
Last Update Posted: September 25, 2017
Last Verified: September 2017

Keywords provided by George Washington University:

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Psychomotor Agitation
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Psychomotor Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents