Ziprasidone vs Standard Therapy for Agitated Patients in the ED
NCT00786318
Last updated date
ABOUT THIS STUDY
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.
Study Location
The George Washington University Medical Center, Dept of Emergency Medicine
Washington, D.C., District of Columbia, 20037, United States
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Psychosis, Agitation, Delirium
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-100 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Acutely agitated
- Requires chemical sedation
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Physician preference for a specific chemical sedative
- Known allergy to any study medications
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Psychosis, Agitation, DeliriumZiprasidone vs Standard Therapy for Agitated Patients in the ED
NCT00786318
- Washington, D.C., District of Columbia
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||
|---|---|---|---|
| Brief Title ICMJE | Ziprasidone vs Standard Therapy for Agitated Patients in the ED | ||
| Official Title ICMJE | 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 | ||
| 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 Provided | ||
| Study Type ICMJE | Interventional | ||
| Study Phase ICMJE | Phase 4 | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment | ||
| Condition ICMJE |
| ||
| Intervention ICMJE |
| ||
| Study Arms ICMJE |
| ||
| Publications * | Brown J. The spectrum of informed consent in emergency psychiatric research. Ann Emerg Med. 2006 Jan;47(1):68-74. Epub 2005 Nov 17. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||
| Recruitment Information | |||
| Recruitment Status ICMJE | Withdrawn | ||
| Actual Enrollment ICMJE | 0 | ||
| Original Estimated Enrollment ICMJE | 300 | ||
| Estimated Study Completion Date ICMJE | July 2011 | ||
| Estimated Primary Completion Date | July 2011 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||
| Sex/Gender ICMJE |
| ||
| Ages ICMJE | 18 Years to 100 Years (Adult, Older Adult) | ||
| Accepts Healthy Volunteers ICMJE | No | ||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number ICMJE | NCT00786318 | ||
| Other Study ID Numbers ICMJE | 010411 (completed) | ||
| Has Data Monitoring Committee | No | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement ICMJE | Not Provided | ||
| Responsible Party | Jeremy Brown, Dept of Emergency Medicine, The George Washington University Medical Center | ||
| Study Sponsor ICMJE | George Washington University | ||
| Collaborators ICMJE | Pfizer | ||
| Investigators ICMJE | Not Provided | ||
| PRS Account | George Washington University | ||
| Verification Date | September 2017 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||