Overview

This trial is active, not recruiting.

Conditions psychosis, agitation, delirium
Treatments ziprasidone, standard therapy
Phase phase 4
Sponsor George Washington University
Collaborator Pfizer
Start date September 2008
End date January 2010
Trial size 300 participants
Trial identifier NCT00786318, 010411

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment

Primary Outcomes

Measure
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 Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Acutely agitated - Requires chemical sedation Exclusion Criteria: - Physician preference for a specific chemical sedative - Known allergy to any study medications

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in June 2010.
Information provided to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).