NCT02504450

Brief Summary

To review records of patients treated with antipsychotics (including Adasuve, Geodon, Haldol) in order to evaluate outcomes.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 4, 2024

Status Verified

July 1, 2016

Enrollment Period

11 months

First QC Date

July 17, 2015

Last Update Submit

October 2, 2024

Conditions

Agitation,Psychomotor

Keywords

Bipolar 1 disorderschizophrenia

Outcome Measures

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.

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

Secondary Outcomes (1)

  • Disposition

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

Interventions

AdasuveDRUG

Inhaled medication to treat acute agitation in the emergency department

Also known as: Loxapine
Alternative medicationsDRUG

Medication given to treat acute agitation in the emergency department

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

subjects treated in the emergency department for agitation

You may qualify if:

  • All patients given antipsychotic therapy for acute agitation

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 20528148RESULT

  • 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.

    PMID: 25210413RESULT

MeSH Terms

Conditions

Psychomotor AgitationSchizophrenia

Interventions

LoxapineHaloperidolziprasidone

Condition Hierarchy (Ancestors)

DyskinesiasNeurologic ManifestationsNervous System DiseasesPsychomotor DisordersNeurobehavioral ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsAberrant Motor Behavior in DementiaBehavioral SymptomsBehaviorSchizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

DibenzoxazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsButyrophenonesKetonesOrganic Chemicals

Study Officials

  • Erik Kulstad, MD

    Advocate Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2015

First Posted

July 22, 2015

Study Start

April 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

October 4, 2024

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share