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Ziprasidone vs Standard Therapy for Agitated Patients in the ED

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00786318
First received: November 5, 2008
Last updated: June 18, 2010
Last verified: June 2010
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of time taken to sedate patient [ Time Frame: Ed visit ] [ Designated as safety issue: No ]
  • Total time spent in restraints [ Time Frame: ED visit ] [ Designated as safety issue: No ]
  • Cost effectiveness of the therapy [ Time Frame: ED visit ] [ Designated as safety issue: No ]

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00786318

Locations
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
Pfizer
  More Information

Publications:

Responsible Party: Jeremy Brown, Dept of Emergency Medicine, The George Washington University Medical Center
ClinicalTrials.gov Identifier: NCT00786318     History of Changes
Other Study ID Numbers: 010411
Study First Received: November 5, 2008
Last Updated: June 18, 2010
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Delirium
Mental Disorders
Psychotic Disorders
Psychomotor Agitation
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Schizophrenia and Disorders with Psychotic Features
Dyskinesias
Psychomotor Disorders
Ziprasidone
 Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 16, 2013