Comparison of Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia

Study Overview
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Brief Summary
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Key objectives of this clinical study are to: Determine how well intramuscular (IM) olanzapine depot works compared to placebo Evaluate the safety and tolerability of IM olanzapine depot compared to placebo Evaluate different doses of IM olanzapine depot compared to placebo to identify the best dose(s).

Official Title
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A Double-Blind, Randomized Study Comparing Intramuscular Olanzapine Depot With Placebo in the Treatment of Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Intramuscular Olanzapine Depot
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must have schizophrenia and be experiencing a psychotic episode Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent Patient must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to the study entry Female patients must not be pregnant or breast-feeding Female patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia Exclusion Criteria: Patients who were previously treated with olanzapine and are considered to be treatment-resistant to olanzapine, in the opinion of the investigator One or more seizures without a clear and resolved etiology is exclusionary. However, if the patient has had one or more seizures in the past with an identifiable etiology, and that etiology has been resolved, the patient may be entered. Treatment with clozapine within 4 weeks prior to visit 1 DSM-IV or DSM-IV-TR substance (except nicotine and caffeine) dependence within the past 30 days Treatment with remoxipride within 6 months (180 days) prior to visit 1

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Intramuscular Olanzapine Depot|nan|
|Drug: Placebo|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstrate superiority of IM olanzapine depot 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks dosages compared with placebo in the treatment of patients with schizophrenia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in CGI-I |  |  | 
| To determine the earliest time point at which 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot show superior clinical improvement compared with placebo |  |  | 
| To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in CGI-S |  |  | 
| To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in terms of change in PANSS Positive, PANSS Negative and PANSS General Psychopathology subscales |  |  | 
| To assess the efficacy of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo in change from baseline to endpoint in quality of life |  |  | 
| To evaluate the safety and tolerability of 300 mg/2 weeks, 405 mg/4 weeks, and 210 mg/2 weeks IM olanzapine depot compared with placebo |  |  | 
| To characterize the pharmacokinetics of olanzapine following multiple dosing with IM olanzapine depot at each of the prescribed dosing regimens |  |  |