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

University of Arkansas

Status and phase: Terminated; Phase 4

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

Treatments: Drug: Loxapine; Drug: Haloperidol + lorazepam

Study type: Interventional

Funder types: Other

Identifiers

NCT03110900

206292

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2 participants in 2 patient groups

haloperidol + lorazepam

Active Comparator group

Description:

IM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler

Treatment:

Drug: Haloperidol + lorazepam

loxapine

Experimental group

Description:

Inhaled loxapine 10mg + IM normal saline

Treatment:

Drug: Loxapine