Ziprasidone vs Standard Therapy for Agitated Patients in the ED

Phase 4

Withdrawn

• Conditions: Agitation; Psychosis; Delirium
• Interventions: Drug: Standard therapy; Drug: ziprasidone

• Registration Number: NCT00786318
• Lead Sponsor: George Washington University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2008-11-05
• Study First Submitted QC: 2008-11-05
• Study First Posted: 2008-11-06
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-22
• Last Update Posted: 2017-09-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Acutely agitated
• Requires chemical sedation

Exclusion Criteria

• Physician preference for a specific chemical sedative
• Known allergy to any study medications

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard therapy	Standard therapy	-
ziprasidone	ziprasidone	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Total time spent in restraints	ED visit
Length of time taken to sedate patient	Ed visit
Cost effectiveness of the therapy	ED visit

Trial Locations

Locations (1)

The George Washington University Medical Center, Dept of Emergency Medicine; 🇺🇸 Washington, D.C., District of Columbia, United States