Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia

Study Overview
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Brief Summary
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The purpose of this study is to compare intramuscular Olanzapine and intramuscular Haloperidol in changing of agitation in patients with schizophrenia

Official Title
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A Double-Blind Randomized Comparison of the Efficacy and Safety of Intramuscular Olanzapine and Intramuscular Haloperidol in Acutely Agitated Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Olanzapine Hydrochloride
* Drug: Haloperidol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients, between the ages of 18 and 65 Patients must have diagnosis of schizophrenia that meets disease diagnostic criteria as defined in DSM-IV Patients must be considered, by the investigator, to be clinically agitated and appropriate candidates for treatment with IM medication. Investigator must believe that it is safe to administer IM olanzapine and IM comparator to the patients with respect to the safety profile of these drugs (including the anticholinergic properties of Olanzapine IM or the comparator agent) Subjects' illness must not, in the opinion of the investigator, be caused by substance abuse Patient must be hospitalized during the study Exclusion Criteria: Previous participation (treatment with study drug) in a Lilly sponsored intra-muscular olanzapine clinical trial Serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months Have a known diagnosis of dementia of any type, as defined in the DSM-IV or DSM-IV-TR Documented history of allergic reaction to study medication(s) Treatment with an injectable depot neuroleptic within 1 injection interval prior to study drug administration

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Olanzapine Hydrochloride|nan|
|Drug: Haloperidol|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of IM olanzapine compared with IM haloperidol in changing of agitation from baseline to 2 hours post-first IM injection |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess treatment-emergent adverse events, change in vital signs and extrapyramidal symptoms of IM olanzapine versus IM haloperidol during the study |  |  | 
| Assess the efficacy of IM olanzapine compared with IM haloperidol from baseline to 15 min, 30 min, 60 min and 120 minutes post-first IM injection |  |  | 
| Compare the response rates and time to response during the 2 hours post-first IM injection. |  |  |