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Ziprasidone vs Standard Therapy for Agitated Patients in the ED

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2010 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was:  Active, not recruiting
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Identifier:
First received: November 5, 2008
Last updated: June 18, 2010
Last verified: June 2010
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 Intervention Phase
Psychosis Agitation Delirium Drug: ziprasidone Drug: Standard therapy Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Outcome Measures:
  • 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:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: September 2008
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ziprasidone
    ziprasidone 20mg IM
    Drug: Standard therapy
    Haldol 5mg/ Ativan 2mg IM

Ages Eligible for Study:   18 Years and older   (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
  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 identifier: NCT00786318

United States, District of Columbia
The George Washington University Medical Center, Dept of Emergency Medicine
Washington, District of Columbia, United States, 20037
Sponsors and Collaborators
George Washington University
  More Information

Responsible Party: Jeremy Brown, Dept of Emergency Medicine, The George Washington University Medical Center Identifier: NCT00786318     History of Changes
Other Study ID Numbers: 010411
Study First Received: November 5, 2008
Last Updated: June 18, 2010

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

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 processed this record on August 18, 2017