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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
2
Haloperidol + lorazepam + placebo
loxapine + placebo
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
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
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