Study Stopped
Sponsor terminated
Ziprasidone vs Standard Therapy for Agitated Patients in the ED
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
1 other identifier
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Sep 2008
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 5, 2008
CompletedFirst Posted
Study publicly available on registry
November 6, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedSeptember 25, 2017
September 1, 2017
2.8 years
November 5, 2008
September 22, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Length of time taken to sedate patient
Ed visit
Total time spent in restraints
ED visit
Cost effectiveness of the therapy
ED visit
Study Arms (2)
ziprasidone
EXPERIMENTALStandard therapy
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Acutely agitated
- Requires chemical sedation
You may not qualify if:
- Physician preference for a specific chemical sedative
- Known allergy to any study medications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- George Washington Universitylead
- Pfizercollaborator
Study Sites (1)
The George Washington University Medical Center, Dept of Emergency Medicine
Washington D.C., District of Columbia, 20037, United States
Related Publications (1)
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.
PMID: 16387220BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 5, 2008
First Posted
November 6, 2008
Study Start
September 1, 2008
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
September 25, 2017
Record last verified: 2017-09