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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-30

Study Completion Date

2018-04-04

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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haloperidol + lorazepam

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

Group Type ACTIVE_COMPARATOR

Haloperidol + lorazepam

Intervention Type DRUG

Haloperidol + lorazepam + placebo

loxapine

Inhaled loxapine 10mg + IM normal saline

Group Type EXPERIMENTAL

Loxapine

Intervention Type DRUG

loxapine + placebo

Interventions

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Haloperidol + lorazepam

Haloperidol + lorazepam + placebo

Intervention Type DRUG

Loxapine

loxapine + placebo

Intervention Type DRUG

Other Intervention Names

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Haldol + Ativan Adasuve

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes