The purpose of this study is to assess the efficacy and safety of intramuscular olanzapine for the treatment of acute agitation associated with schizophrenia and bipolar I mania.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
318
intramuscular injection, 10 mg/dose, first dose and an optional second or third dose.
intramuscular injection, 7.5 mg/dose, first dose and an optional second or third dose.
Change from baseline to 2 hours post-first IM injection on the PANSS-EC
The PANSS-EC comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)
Time frame: 2 hours
Percentage of Participants With 40% or Greater Percent Decrease in the PANSS-EC Total Score
Time frame: 2 hours post-first IM injection
Proportion of participants receiving one, two, or three doses of study drug during 24-hour intramuscular treatment period
Time frame: 24 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.