Official Title: “An Open-Label Study of Intramuscular Olanzapine Depot in Patients With Schizophrenia or Schizoaffective Disorder”

This is a long-term, open-label clinical study designed to enable longer-term treatment of patients completing other clinical studies with intramuscular olanzapine depot.

Key objectives of the study are to: - Determine how well intramuscular (IM) olanzapine depot works during long-term treatment, - Evaluate the safety and tolerability of IM olanzapine depot during long-term treatment, - Determine the blood levels of IM olanzapine depot in patients during long-term treatment

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Intramuscular Olanzapine Depot

Primary Measures

• To assess the long-term safety of IM olanzapine depot in patients diagnosed with schizophrenia or schizoaffective disorder by monitoring laboratory values, vital signs, electrocardiograms, adverse events and extrapyramidal symptoms

Secondary Measures

• To assess long-term efficacy of IM olanzapine depot in patients diagnosed with schizophrenia or schizoaffective
• disorder by measuring PANSS total, positive, negative, and general psychopathology subscales and Clinical Global
• Impression-severity scores
• To assess long-term impact of IM olanzapine depot on quality of life in patients diagnosed with schizophrenia
• or schizoaffective disorder by assessing quality of life measures, resource utilization and hospitalization
• measures, subjective well-being under neuroleptics treatment measures, and patient satisfaction with
• medication questionnaire
• To characterize the pharmacokinetics of IM olanzapine depot during long-term treatment

Inclusion Criteria:

• Patients must have schizophrenia
• Female patients of childbearing potential must be using a medically accepted means of contraception
• Patients must have completed (within 10 days) another IM olanzapine depot study if permitted by that study's protocol.

Exclusion Criteria:

• Patients must not have participated in a clinical trial of another investigational drug, including olanzapine, within 1 month (30 days) prior to study entry
• Female patients must not be pregnant or breast-feeding
• Patients must not be experiencing acute, serious or unstable medical conditions other than schizophrenia or schizoaffective disorder
• Patients must not have a substance (except nicotine or caffeine) dependence within the past 30 days

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 76 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00088465

Study ID Number: 5995

ClinicalTrials.gov Identifier: NCT00088465

Health Authority: United States: Food and Drug Administration