A Study of Olanzapine in Patients With Acute Agitation

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Randomized, Double-blind, Parallel-controlled Injection of Olanzapine in the Treatment of Acute Agitation Associated With Schizophrenia and Bipolar I Disorder.

Conditions
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Acute Agitation

Intervention / Treatment
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* Drug: Olanzapine
* Drug: Haloperidol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients between the ages of 18 to 65 years, inclusive. Patients who have met DSM-5 criteria for schizophrenia and bipolar I disorder. Patients who are judged to be clinically acutely agitated with a total score of ≥ 14 on the 5 items comprising the PANSS-EC and at least one individual item score≥ 4 immediately before randomization. Exclusion Criteria: Patients with agitation caused by delirium, seizures, developmental delay, poisoning, etc., or withdrawal from drug abuse. Patients who have had previous suicidal behavior or currently at serious risk of suicide. Patients with glaucoma or at risk of angle-closure glaucoma. Patients who have brain diseases such as intracranial infection, brain trauma, cerebrovascular disease, basal ganglion disease, hypoxic encephalopathy, Parkinson's disease, Parkinson's syndrome, and dementia. Use of benzodiazepines, other hypnotics or short-acting antipsychotic drugs within 4 hours before randomization. Treatment with psychostimulants or reserpine within one week before randomization. Patients who received long-acting injections of typical or atypical antipsychotics within 2 weeks prior to randomization or within one injection interval. Treatment with clozapine within 4 weeks before screening. Patients with serious or unstable medical illnesses. Female patients who have a positive pregnancy test at screening or are breastfeeding. Patients who have participated in other clinical trials within 3 months before randomization.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Olanzapine<br> | Drug: Olanzapine<br>* intramuscular injection, 10 mg/dose, first dose and an optional second or third dose.<br>|
| Active Comparator: Haloperidol<br> | Drug: Haloperidol<br>* intramuscular injection, 7.5 mg/dose, first dose and an optional second or third dose.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With 40% or Greater Percent Decrease in the PANSS-EC Total Score |  | 2 hours post-first IM injection | 
| Proportion of participants receiving one, two, or three doses of study drug during 24-hour intramuscular treatment period |  | 24 hours |