Key objectives of this clinical study are to: - Determine how well intramuscular (IM) olanzapine depot works compared to oral olanzapine - Evaluate the safety and tolerability of IM olanzapine depot compared to oral olanzapine - Evaluate different doses of IM olanzapine depot to identify the best dose(s) - Determine the blood levels of IM olanzapine depot in patients at different points in time after an injection

Condition	Treatment or Intervention	Phase
Schizophrenic Disorders	Drug: Intramuscular Olanzapine Depot	Phase III

Ages Eligible for Study:  18 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patients must have schizophrenia
• Patients must be retrospectively judged by investigators, based on clinical interview and impression to have been stable on their antipsychotic medication (with respect to their symptoms of schizophrenia) for at least 4 weeks entry into the study
• Each patient must have a level of understanding sufficient to complete all tests and examinations required by the protocol, and to provide informed consent
• Patients must not have paticipated 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

"There may be multiple sites in this clinical trial."      1-877-CTLILLY (1-877-285-4559) 

Argentina
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Buenos Aires,  Argentina
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Mendoza,  Argentina
Brazil
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Rio de Janeiro,  Brazil
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Salvador,  Brazil
Bulgaria
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Sofia,  Bulgaria
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Varna,  Bulgaria
Croatia
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Zagreb,  Croatia
France
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Paris,  France
Germany
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Hamburg,  Germany
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physicianM, Muchen,  Germany
Greece
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Chaidari,  Greece
Israel
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Bat Yam,  Israel
Italy
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Torino,  Italy
Mexico
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Mexico City,  Mexico
Puerto Rico
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Ponce,  Puerto Rico
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Rio Piedras,  Puerto Rico
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, San Juan,  Puerto Rico
Spain
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Barcelona,  Spain
Taiwan, Province of China
      For additional information regarding investigative sites for this trial, contact (1-877-285-4559) or speak with your personal physician, Taipei,  Taiwan, Province of China

Study ID Numbers:  5985
Record last reviewed:  July 2004
Record first received:  July 26, 2004
ClinicalTrials.gov Identifier:  NCT00088491
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2004-10-20