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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00786318

Enrollment

Registered

2008-11-06

Start date

2008-09-30

Completion date

2011-07-31

Last updated

2017-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Agitation, Delirium, Psychosis

Keywords

Psychosis, Agitation, Delirium

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.

Interventions

DRUGziprasidone

ziprasidone 20mg IM

DRUGStandard therapy

Haldol 5mg/ Ativan 2mg IM

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

* Acutely agitated * Requires chemical sedation

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026