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

Eli Lilly and Company402 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

402

Conditions

Schizophrenia

Interventions

Intramuscular Olanzapine DepotDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (37)

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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National City, California, United States

Orange, California, United States

Rosemead, California, United States

San Diego, California, United States

Santa Ana, California, United States

Denver, Colorado, United States

Washington D.C., District of Columbia, United States

Bradenton, Florida, United States

Honolulu, Hawaii, United States

Chicago, Illinois, United States

...and 27 more locations