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Ziprasidone vs Standard Therapy for Agitated Patients in the ED

Primary Purpose

Psychosis, Agitation, Delirium

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ziprasidone
Standard therapy
Sponsored by
George Washington University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring Psychosis, Agitation, Delirium

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acutely agitated
  • Requires chemical sedation

Exclusion Criteria:

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

Sites / Locations

  • The George Washington University Medical Center, Dept of Emergency Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ziprasidone

Standard therapy

Arm Description

Outcomes

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

Secondary Outcome Measures

Length of time taken to sedate patient
Total time spent in restraints
Cost effectiveness of the therapy

Full Information

First Posted
November 5, 2008
Last Updated
September 22, 2017
Sponsor
George Washington University
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00786318
Brief Title
Ziprasidone vs Standard Therapy for Agitated Patients in the ED
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 Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor terminated
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2011 (Anticipated)
Study Completion Date
July 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
George Washington University
Collaborators
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Agitation, Delirium
Keywords
Psychosis, Agitation, Delirium

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ziprasidone
Arm Type
Experimental
Arm Title
Standard therapy
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
ziprasidone
Intervention Description
ziprasidone 20mg IM
Intervention Type
Drug
Intervention Name(s)
Standard therapy
Intervention Description
Haldol 5mg/ Ativan 2mg IM
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Length of time taken to sedate patient
Time Frame
Ed visit
Title
Total time spent in restraints
Time Frame
ED visit
Title
Cost effectiveness of the therapy
Time Frame
ED visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acutely agitated Requires chemical sedation Exclusion Criteria: Physician preference for a specific chemical sedative Known allergy to any study medications
Facility Information:
Facility Name
The George Washington University Medical Center, Dept of Emergency Medicine
City
Washington, D.C.
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16387220
Citation
Brown J. The spectrum of informed consent in emergency psychiatric research. Ann Emerg Med. 2006 Jan;47(1):68-74. doi: 10.1016/j.annemergmed.2005.08.025. Epub 2005 Nov 17.
Results Reference
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Ziprasidone vs Standard Therapy for Agitated Patients in the ED

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