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CompletedNCT02504450OAMEDUpdated Oct 4, 2024

Outcomes of Antipsychotic Medication Used in the Emergency Department

An observational study in Agitation,Psychomotor, sponsored by Wake Forest University Health Sciences. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-10-04.

Sponsored by Wake Forest University Health Sciences · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
93
Ages
18 Years to 80 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Agitation,Psychomotor

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Keywords

  • Bipolar 1 disorder
  • schizophrenia
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In context

Psychomotor Agitation

500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.

This study's enrollment of 93 is below the median of 154 across 71 observational studies indexed under Psychomotor Agitation.

Browse Psychomotor Agitation studies →

Lead sponsor

Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.

Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

subjects treated in the emergency department for agitation

Inclusion criteria

  • All patients given antipsychotic therapy for acute agitation

Exclusion criteria

Exclusion Criteria:

  • None
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Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
93 participants (actual)
Patient registry
No

Interventions

  • DrugAdasuve

    Inhaled medication to treat acute agitation in the emergency department

    Also known as: Loxapine

  • DrugAlternative medications

    Medication given to treat acute agitation in the emergency department

    Also known as: Haloperidol, Serenace, Peridol, Haldon, Geodon, Ziprasidone

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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

    Time frame: Participants will be followed for the duration of emergency department stay, an expected average of 12 hours.

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Study locations

No study locations are listed for this record.

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References and documents

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 20528148 ↗
  • Valdes 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 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 4, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02504450
Lead sponsor
Wake Forest University Health Sciences
Responsible party
Sponsor
First posted
Jul 22, 2015
Start date
Apr 2015
Primary completion
Mar 2016
Completion
Mar 2016
Last update
Oct 4, 2024

Study contacts

Erik Kulstad, MD
principal investigator · Advocate Healthcare

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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