Ziprasidone vs Standard Therapy for Agitated Patients in the ED

Delirium Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00786318
• Other study ID #: 010411 (completed)
• Status: Withdrawn
• Phase: Phase 4
• First received: November 5, 2008
• Last updated: September 22, 2017
• Start date: September 2008
• Est. completion date: July 2011

Study information

• Verified date: September 2017
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Acutely agitated

• Requires chemical sedation

Exclusion Criteria:

• Physician preference for a specific chemical sedative

• Known allergy to any study medications

Related Conditions & MeSH terms

• Agitation
• Delirium
• Mental Disorders
• Psychomotor Agitation
• Psychosis
• Psychotic Disorders

Intervention

Drug:
• ziprasidone
ziprasidone 20mg IM
• Standard therapy
Haldol 5mg/ Ativan 2mg IM

Locations

Country	Name	City	State
United States	The George Washington University Medical Center, Dept of Emergency Medicine	Washington, D.C.	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
George Washington University	Pfizer

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	length of time from triage until patient is either ready to be seen by psychiatry or is ready to have a disposition made		During ED stay
Secondary	Length of time taken to sedate patient		Ed visit
Secondary	Total time spent in restraints		ED visit
Secondary	Cost effectiveness of the therapy		ED visit