Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Agitation,Psychomotor, Haloperidol Causing Adverse Effects in Therapeutic Use, Lorazepam Causing Adverse Effects in Therapeutic Use, Loxapine Causing Adverse Effects in Therapeutic Use

In brief

The primary objective of this study is to determine the noninferiority of inhaled loxapine compared to intramuscular haloperidol/lorazepam on agitation reduction at 120 minutes.

Key facts

Study ID

NCT03110900

Run by

University of Arkansas

People needed

2

Starts

2017-09-30

Expected to finish

2018-04-04

Last updated by the study team

2018-06-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Requires treatment for agitation in the judgment of a physician
• Patient either pre-consented, has surrogate consent, or able to consent (in cases of mild agitation).
• The patient is at least 18 years of age and less than 65 years of age.
• Patients with known or presumed schizophrenia or bipolar 1 disorder.

You may not qualify if…

• Patients with acute respiratory signs/symptoms (eg, wheezing).
• Known diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or asthma or taking meds for asthma or COPD.
• Female patients who are obviously pregnant or breast-feeding.
• Medically unstable patients.
• Patients or surrogates who object to being in the study (even if previously pre-consented).
• Physician objection to patient enrollment in the study.
• Prisoners or incarcerated.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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