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).

Condition	Treatment or Intervention	Phase
Schizophrenia	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 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

California
      For additional information regarding investigative sites for this trial, contact 1-877-285-4559) or speak with your personal physician., San Diego,  California,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Santa Ana,  California,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., National City,  California,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Orange,  California,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Rosemead,  California,  United States
Colorado
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Denver,  Colorado,  United States
District of Columbia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Washington,  District of Columbia,  United States
Florida
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Bradenton,  Florida,  United States
Hawaii
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Honolulu,  Hawaii,  United States
Illinois
      For additional information regarding investigative sites for this trial, contact 1-877-285-4559) or speak with your personal physician., Hoffman Estates,  Illinois,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Chicago,  Illinois,  United States
Louisiana
      For additional information regarding investigative sites for this trial, contact 1-877-285-4559) or speak with your personal physician., Lake Charles,  Louisiana,  United States
Maryland
      For additional information regarding investigative sites for this trial, contact 1-877-285-4559) or speak with your personal physician., Baltimore,  Maryland,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Rockville,  Maryland,  United States
Michigan
      For additional information regarding investigative sites for this trial, contact 1-877-285-4559) or speak with your personal physician., St. Louis,  Michigan,  United States
Missouri
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Kansas City,  Missouri,  United States
Nevada
      For additional information regarding investigative sites for this trial, contact 1-877-285-4559) or speak with your personal physician., Las Vegas,  Nevada,  United States
      For additional information regarding investigative sites for this trial, contact 1-877-285-4559) or speak with your personal physician., Reno,  Nevada,  United States
New Jersey
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Clementon,  New Jersey,  United States
New York
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Lawrence,  New York,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., New York,  New York,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Rochester,  New York,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Staten Island,  New York,  United States
Ohio
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Beachwood,  Ohio,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Chagrin Falls,  Ohio,  United States
Oklahoma
      For additional information regarding investigative sites for this trial, contact 1-877-285-4559) or speak with your personal physician., Oklahoma City,  Oklahoma,  United States
Pennsylvania
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Norristown,  Pennsylvania,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Philadelphia,  Pennsylvania,  United States
South Carolina
      For additional information regarding investigative sites for this trial, contact 1-877-285-4559) or speak with your personal physician., Columbia,  South Carolina,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Travelers Rest,  South Carolina,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Columbia,  South Carolina,  United States
Texas
      For additional information regarding investigative sites for this trial, contact 1-877-285-4559) or speak with your personal physician., Houston,  Texas,  United States
      For additional information regarding investigative sites for this trial, contact 1-877-285-4559) or speak with your personal physician., Kirkland,  Texas,  United States
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., San Antonio,  Texas,  United States
Washington
      For additional information regarding investigative sites for this trial, contact 1-877-285-4559) or speak with your personal physician., Kirkland,  Washington,  United States
Croatia
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Zagreb,  Croatia
Russian Federation
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., Moscow,  Russian Federation
      For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., St Petersburg,  Russian Federation

Study ID Numbers:  5984
Record last reviewed:  March 2005
Last Updated:  March 23, 2005
Record first received:  July 26, 2004
ClinicalTrials.gov Identifier:  NCT00088478
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08