Agitation,PsychomotorOAMEDNCT02504450
Outcomes of Antipsychotic Medication Used in the Emergency Department
An observational study of Agitation,Psychomotor, run by Wake Forest University Health Sciences.
Trial summary
To review records of patients treated with antipsychotics (including Adasuve, Geodon, Haldol) in order to evaluate outcomes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Agitation,Psychomotor
- What is being tested?
- Adasuve and Alternative medications
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Mar 2016
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: subjects treated in the emergency department for agitation
Who may be able to join
- All patients given antipsychotic therapy for acute agitation
Who cannot join
- None
About this study
Official title: Outcomes of Antipsychotic Medication Use in the Emergency Department: A Retrospective Comparison Study
To review records of patients treated with antipsychotics (including Adasuve, Geodon, Haldol) in order to evaluate outcomes.
Read the detailed description
A retrospective chart review will be performed for all patients presenting to the ED with agitation and subsequently given antipsychotic therapy for treatment. Identification of patients will be through chart review of patients presenting with agitation. Data to be recorded include patient age, gender, medical history, time of presentation, time of treatment, co morbidities, use of restraint, time to disposition and patient outcome. Inclusion criteria include all patients over age 18 presenting to the ED with agitation and treated with antipsychotics. No patients will be knowingly excluded from analysis. We will compare resulting outcomes of patients treated for agitation to see if Adasuve is superior to other commonly prescribed antipsychotics through its rate of discharge home and overall time in the emergency department.
- Conditions
- Agitation,Psychomotor
- Being tested
- Adasuve, Alternative medications
- Keywords
- Bipolar 1 disorder, schizophrenia
- Medical subject headings
- Psychomotor Agitation, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdasuveDrug
Also called Loxapine
Inhaled medication to treat acute agitation in the emergency department
Alternative medicationsDrug
Also called Haloperidol, Serenace, Peridol, Haldon, Geodon, Ziprasidone
Medication given to treat acute agitation in the emergency department
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in the emergency department
We will compare resulting outcomes of patients treated for agitation to see if Adasuve is superior to other commonly prescribed antipsychotics through its rate of discharge home and overall time in the emergency department.
Measured: Participants will be followed for the duration of emergency department stay, an expected average of 12 hours.
Secondary outcomes (1)
Disposition
disposition (home, transfer, admit), and time to disposition
Measured: Participants will be followed for the duration of emergency department stay, an expected average of 12 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Agitation,PsychomotorStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik Kulstad, MD, Principal investigator, Advocate Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504450
- Sponsor's protocol ID
- AHC6066
- Acronym
- OAMED
- Status last verified
- Jul 2016
- First submitted
- 17 Jul 2015
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Dinh KV, Myers DJ, Noymer PD, Cassella JV. In vitro aerosol deposition in the oropharyngeal region for Staccato loxapine. J Aerosol Med Pulm Drug Deliv. 2010 Aug;23(4):253-60. doi: 10.1089/jamp.2009.0814.
PubMed 20528148Valdes J, Shipley T, Rey JA. Loxapine inhalation powder (adasuve): a new and innovative formulation of an antipsychotic treatment for agitation. P T. 2014 Sep;39(9):621-3, 648.
PubMed 25210413
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes of Antipsychotic Medication Use in the Emergency Department: A Retrospective Comparison Study
- ClinicalTrials.gov ID
- NCT02504450
- Acronym / sponsor ID
- OAMED / AHC6066
- Conditions
- Agitation,Psychomotor
- Keywords
- Bipolar 1 disorder, schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Jul 2015 (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.
To review records of patients treated with antipsychotics (including Adasuve, Geodon, Haldol) in order to evaluate outcomes.
Detailed description
A retrospective chart review will be performed for all patients presenting to the ED with agitation and subsequently given antipsychotic therapy for treatment. Identification of patients will be through chart review of patients presenting with agitation. Data to be recorded include patient age, gender, medical history, time of presentation, time of treatment, co morbidities, use of restraint, time to disposition and patient outcome. Inclusion criteria include all patients over age 18 presenting to the ED with agitation and treated with antipsychotics. No patients will be knowingly excluded from analysis. We will compare resulting outcomes of patients treated for agitation to see if Adasuve is superior to other commonly prescribed antipsychotics through its rate of discharge home and overall time in the emergency department.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- subjects treated in the emergency department for agitation
Key inclusion criteria (1 listed)
- All patients given antipsychotic therapy for acute agitation
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| AdasuveAlso: LoxapineInhaled medication to treat acute agitation in the emergency department | Drug | – |
| Alternative medicationsAlso: Haloperidol, Serenace, Peridol, Haldon, Geodon, ZiprasidoneMedication given to treat acute agitation in the emergency department | Drug | – |
Primary outcome
Length of stay in the emergency department
Time frame: Participants will be followed for the duration of emergency department stay, an expected average of 12 hours.
We will compare resulting outcomes of patients treated for agitation to see if Adasuve is superior to other commonly prescribed antipsychotics through its rate of discharge home and overall time in the emergency department.
1 secondary outcome
Disposition
Time frame: Participants will be followed for the duration of emergency department stay, an expected average of 12 hours.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Results publication: PubMed 20528148Dinh KV, Myers DJ, Noymer PD, Cassella JV. In vitro aerosol deposition in the oropharyngeal region for Staccato loxapine. J Aerosol Med Pulm Drug Deliv. 2010 Aug;23(4):253-60. doi: 10.1089/jamp.2009.0814.
- Results publication: PubMed 25210413Valdes J, Shipley T, Rey JA. Loxapine inhalation powder (adasuve): a new and innovative formulation of an antipsychotic treatment for agitation. P T. 2014 Sep;39(9):621-3, 648.
- Individual participant dataSharing planned: No
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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.
Erik Kulstad, MD principal investigator
Advocate Healthcare
Questions about this trial
What is this clinical trial studying?
An observational study of Agitation,Psychomotor, run by Wake Forest University Health Sciences.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 stay in the emergency department (time frame: Participants will be followed for the duration of emergency department stay, an expected average of 12 hours.). 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 NCT02504450, which also lists 2 linked publications.
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 4 Oct 2024.