Outcomes of Antipsychotic Medication Used in the Emergency Department

NCT ID: NCT02504450

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 93 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2016-03-31

Brief Summary

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.

Conditions

Agitation,Psychomotor

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Interventions

Adasuve

Inhaled medication to treat acute agitation in the emergency department

Intervention Type: DRUG

Alternative medications

Medication given to treat acute agitation in the emergency department

Intervention Type: DRUG

Other Intervention Names

Loxapine; Haloperidol, Serenace, Peridol, Haldon, Geodon, Ziprasidone

Eligibility Criteria

Inclusion Criteria

• All patients given antipsychotic therapy for acute agitation

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik Kulstad, MD

Role: PRINCIPAL_INVESTIGATOR

Advocate Healthcare

References

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.

Reference Type: RESULT

PMID: 20528148 (View on PubMed)

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.

Reference Type: RESULT

PMID: 25210413 (View on PubMed)

Other Identifiers

AHC6066

Identifier Type: -

Identifier Source: org_study_id