At a glance
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A Double-Blind Confirmatory Study Comparing Rapid-Acting Intramuscular Olanzapine and Rapid-Acting Intramuscular Placebo in Patients With an Exacerbation of Schizophrenia With Acute Psychotic Agitation
In Brief
A Phase 3 clinical trial evaluating Rapid-Acting Intramuscular Olanzapine and Placebo for Schizophrenia. Completed, enrolled 91 participants across 11 sites.
Detailed Summary
The primary objectives of the study is to confirm if the efficacy of intramuscular injection (IM) olanzapine 10 milligrams (mg) in patients with an exacerbation of schizophrenia with acute psychotic agitation is greater than intramuscular placebo by comparing changes from baseline to 2 hours after the first IM injection of agitation.
Study Details
Timeline
Interventions
Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections
Administered by means of IM with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections