Ziprasidone vs Standard Therapy for Agitated Patients in the ED

Condition(s) targeted: Psychosis; Agitation; Delirium

Intervention: ziprasidone (Drug); Standard therapy (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: George Washington University

Overall contact:
Jeremy Brown, MD, Phone: 202 741 2902

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.

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 design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: length of time from triage until patient is either ready to be seen by psychiatry or is ready to have a disposition made

Secondary outcome:

Length of time taken to sedate patient

Total time spent in restraints

Cost effectiveness of the therapy

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Acutely agitated

- Requires chemical sedation

Exclusion Criteria:

- Physician preference for a specific chemical sedative

- Known allergy to any study medications

Jeremy Brown, MD, Phone: 202 741 2902

The George Washington University Medical Center, Dept of Emergency Medicine, Washington, District of Columbia 20037, United States; Recruiting
Jeremy Brown, MD, Principal Investigator

Related 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.

Starting date: September 2008
Ending date: January 2010
Last updated: May 20, 2009