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

• Status: Terminated
• Trial end date: 2018-04-04
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Arkansas
• Collaborator: Mount Sinai Hospital, Chicago
• Treatments: Haloperidol; Haloperidol decanoate; Lorazepam; Loxapine

Criteria

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.