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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 4, 2018

Detailed 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.

Interventions

  • Drug: Haloperidol + lorazepam
    • Haloperidol + lorazepam + placebo
  • Drug: Loxapine
    • loxapine + placebo

Arms, Groups and Cohorts

  • Active Comparator: haloperidol + lorazepam
    • IM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler
  • Experimental: loxapine
    • Inhaled loxapine 10mg + IM normal saline

Clinical Trial Outcome Measures

Primary Measures

  • Number of Subjects Reporting Reduction of Agitation on Positive and Negative Syndrome Scale (PANSS)
    • Time Frame: 120 minutes
    • Change in agitation level on the PANSS from baseline up to 120 minutes — terminated by sponsor before results available

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Arkansas
  • Collaborator
    • Mount Sinai Hospital, Chicago
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael P Wilson, MD, Principal Investigator, UAMS

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