PsychosisPhase 4NCT00786318
Ziprasidone vs Standard Therapy for Agitated Patients in the ED
A Phase 4 study testing ziprasidone and Standard therapy in people with Psychosis and Agitation, run by George Washington University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- What is being tested?
- ziprasidone and Standard therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2008to Jul 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acutely agitated
- Requires chemical sedation
Who cannot join
- Physician preference for a specific chemical sedative
- Known allergy to any study medications
Trial locations and contacts
1 site in 1 country.
United States1 site
The George Washington University Medical Center, Dept of Emergency Medicine
Washington D.C., District of Columbia, 20037
About this study
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
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.
- Being tested
- ziprasidone, Standard therapy
- Keywords
- Psychosis, Agitation, Delirium
- Medical subject headings
- Psychotic Disorders, Psychomotor Agitation, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ziprasidoneDrug
ziprasidone 20mg IM
Standard therapyDrug
Haldol 5mg/ Ativan 2mg IM
| Study group | Role | What they receive |
|---|---|---|
| ziprasidone | Experimental | Not described Receives: Drug: ziprasidone |
| Standard therapy | Active comparator | Not described Receives: Drug: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of time from triage until patient is either ready to be seen by psychiatry or is ready to have a disposition made
Measured: During ED stay
Secondary outcomes (3)
Length of time taken to sedate patient
Measured: Ed visit
Total time spent in restraints
Measured: ED visit
Cost effectiveness of the therapy
Measured: ED visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2008 (estimated)
- Study startSep 2008
- Primary completionJul 2011 (estimated)
- Study completionJul 2011 (estimated)
Why it stopped: Sponsor terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PsychosisStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00786318
- Sponsor's protocol ID
- 010411 (completed)
- Status last verified
- Sep 2017
- First submitted
- 5 Nov 2008
- Last updated
- 25 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16387220
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00786318
- Acronym / sponsor ID
- 010411 (completed)
- Keywords
- Psychosis, Agitation, Delirium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor terminated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Sep 2008
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Jul 2011 (estimated)
- First posted
- 6 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ziprasidone | Experimental | Drug: ziprasidone |
| Standard therapy | Active comparator | Drug: Standard therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acutely agitated
- Requires chemical sedation
Key exclusion criteria (2 listed)
- Physician preference for a specific chemical sedative
- Known allergy to any study medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ziprasidoneziprasidone 20mg IM | Drug | ziprasidone |
| Standard therapyHaldol 5mg/ Ativan 2mg IM | Drug | Standard therapy |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Background: PubMed 16387220Brown 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ziprasidone and Standard therapy in people with Psychosis and Agitation, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00786318, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.