Agitation,Psychomotor, Haloperidol Causing Adverse Effects in Therapeutic Use, Lorazepam Causing Adverse Effects in Therapeutic Use, Loxapine Causing Adverse Effects in Therapeutic Use
Conditions
Brief 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.
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
DRUGHaloperidol + lorazepam
Haloperidol + lorazepam + placebo
DRUGLoxapine
loxapine + placebo
Sponsors
Mount Sinai Hospital, Chicago
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Reporting Reduction of Agitation on Positive and Negative Syndrome Scale (PANSS) | 120 minutes | Change in agitation level on the PANSS from baseline up to 120 minutes -- terminated by sponsor before results available |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Haloperidol + Lorazepam IM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler
Haloperidol + lorazepam: Haloperidol + lorazepam + placebo | 1 |
| Loxapine Inhaled loxapine 10mg + IM normal saline
Loxapine: loxapine + placebo | 1 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Sponsor withdrew | 1 | 1 |
Baseline characteristics
| Characteristic | Loxapine | Total | Haloperidol + Lorazepam |
|---|---|---|---|
| Age, Customized >18 years <99 | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 1 |
| other Total, other adverse events | 0 / 1 | 0 / 1 |
| serious Total, serious adverse events | 0 / 1 | 0 / 1 |
Outcome results
Primary
Number of Subjects Reporting Reduction of Agitation on Positive and Negative Syndrome Scale (PANSS)
Change in agitation level on the PANSS from baseline up to 120 minutes -- terminated by sponsor before results available
Time frame: 120 minutes
Population: No data was collected because the sponsor terminated the study before any data could be collected.