Ziprasidone vs Standard Therapy for Agitated Patients in... | NCT00786318

Studies
Ziprasidone vs Standard Therapy for Agitated Patients in the ED

NCT00786318

Sponsor

George Washington University

Status

Withdrawn

Last Update Posted

Sep 25, 2017Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Psychosis
Agitation
Delirium

Interventions

ziprasidone
Standard therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor terminated

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Jul 2011Estimated

Completion Date

Jul 2011Estimated

First Submitted Date

Nov 5, 2008

First Submission Date that Met QC Criteria

Nov 5, 2008

First Posted Date

Nov 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 22, 2017

Last Update Posted Date

Sep 25, 2017Actual

Name	Class
Pfizer	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ziprasidone	Experimental		Drug: ziprasidone
Standard therapy	Active Comparator		Drug: Standard therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ziprasidone	Drug	ziprasidone 20mg IM	ziprasidone
Standard therapy

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acutely agitated
Requires chemical sedation

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The George Washington University Medical Center, Dept of Emergency Medicine		Washington D.C.	District of Columbia	20037	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16387220	Background	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.

ID	Term
D011618	Psychotic Disorders
D011595	Psychomotor Agitation
D003693	Delirium

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D020820	Dyskinesias
D009461	Neurologic Manifestations

ID	Term
C092292	ziprasidone
D059039	Standard of Care

ID	Term
D019984	Quality Indicators, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration
D017530	Health Care Quality, Access, and Evaluation