Ziprasidone vs Standard Therapy for Agitated Patients in the ED - Full Text View

Sponsor:	George Washington University
Collaborator:	Pfizer
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00786318

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 IV

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:

MedlinePlus related topics: Delirium Mental Disorders Psychotic Disorders

Drug Information available for: Ziprasidone hydrochloride Ziprasidone Ziprasidone mesylate

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:

ziprasidone 20mg IM

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:

Brown J. The spectrum of informed consent in emergency psychiatric research. Ann Emerg Med. 2006 Jan;47(1):68-74. Epub 2005 Nov 17.

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 February 09, 2012