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

A Randomized Double-blind Multicenter Double-dummy Non-inferiority Trial of Inhaled Loxapine and Intramuscular Haloperidol + Lorazepam for the Reduction of Agitation

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.

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.

Inclusion Criteria:

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

Exclusion Criteria:

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